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Pharmaceutical Water System Design Operation & Validation Pdf PowerPoint

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VALIDATION AND QUALIFICATION OF WATER PURIFICATION, STORAGE, AND DISTRIBUTION SYSTEMS: Establishing the dependability of pharmaceutical water purification, storage, and distribution systems requires an appropriate period of monitoring and observation. Ordinarily, few problems are encountered in maintaining the chemical purity of Purified Water and Water for Injection Nevertheless, the advent of using conductivity and TOC to define chemical purity has allowed the user to more quantitatively assess the water’s chemical purity and its variability as a function of routine pretreatment system maintenance and regeneration. Even the presence of such unit operations as heat exchangers and use point hoses can compromise the chemical quality of water within and delivered from an otherwise well-controlled water system. Therefore, an assessment of the consistency of the water’s chemical purity over time must be part of the validation program. However, even with the most well controlled chemical quality, it is often more difficult to consistently meet established microbiological quality criteria owing to phenomena occurring during and after chemical purification. A typical program involves intensive daily sampling and testing of major process points for at least one month after operational criteria have been established for each unit operation, point of use, and sampling point.

VALIDATION AND QUALIFICATION OF WATER PURIFICATION, STORAGE, AND DISTRIBUTION SYSTEMS

An overlooked aspect of water system validation is the delivery of the water to its actual location of use. If this transfer process from the distribution system outlets to the water use locations (usually with hoses) is defined as outside the water system, then this transfer process still needs to be validated to not adversely affect the quality of the water to the extent it becomes unfit for use. Because routine microbial monitoring is performed for the same transfer process and components (e.g., hoses and heat exchangers) as that of routine water use (see Sampling Considerations), there is some logic to include this water transfer process within the distribution system validation.

Validation is the process whereby substantiation to a high level of assurance that a specific process will consistently produce a product conforming to an established set of quality attributes is acquired and documented. Prior to and during the very early stages of validation, the critical process parameters and their operating ranges are established. A validation program qualifies and documents the design, installation, operation, and performance of equipment. It begins when the system is defined and moves through several stages: installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). A graphical representation of a typical water system validation life cycle is shown in Figure.

PPT PDF Pharmaceutical Water System Validation Pdf PowerPoint

Pharmaceutical Water system validation life cycle.

A validation plan for a water system typically includes the following steps: (1) establishing standards for quality attributes of the finished water and the source water; (2) defining suitable unit operations and their operating parameters for achieving the desired finished water quality attributes from the available source water; (3) selecting piping, equipment, controls, and monitoring technologies; (4) developing an IQ stage consisting of instrument calibrations, inspections to verify that the drawings accurately depict the final configuration of the water system and, where necessary, special tests to verify that the installation meets the design requirements; (5) developing an OQ stage consisting of tests and inspections to verify that the equipment, system alerts, and controls are operating reliably and that appropriate alert and action levels are established (This phase of qualification may overlap with aspects of the next step.); and (6) developing a prospective PQ stage to confirm the appropriateness of critical process parameter operating ranges (During this phase of validation, alert and action levels for key quality attributes and operating parameters are verified.); (7) assuring the adequacy of ongoing control procedures, e.g., sanitization frequency; (8) supplementing a validation maintenance program (also called continuous validation life cycle) that includes a mechanism to control changes to the water system and establishes and carries out scheduled preventive maintenance including recalibration of instruments (In addition, validation maintenance includes a monitoring program for critical process parameters and a corrective action program.); (9) instituting a schedule for periodic review of the system performance and requalification, and (10) completing protocols and documenting Steps 1 through 9.

PURIFIED WATER AND WATER FOR INJECTION SYSTEMS

The design, installation, and operation of systems to produce Purified Water and Water for Injection include similar components, control techniques, and procedures. The quality attributes of both waters differ only in the presence of a bacterial endotoxin requirement for Water for Injection and in their methods of preparation, at least at the last stage of preparation. The similarities in the quality attributes provide considerable common ground in the design of water systems to meet either requirement. The critical difference is the degree of control of the system and the final purification steps needed to ensure bacterial and bacterial endotoxin removal.

Production of pharmaceutical water

Production of pharmaceutical water employs sequential unit operations (processing steps) that address specific water quality attributes and protect the operation of subsequent treatment steps. A typical evaluation process to select an appropriate water quality for a particular pharmaceutical purpose is shown in the decision tree in Figure 2. This diagram may be used to assist in defining requirements for specific water uses and in the selection of unit operations. The final unit operation used to produce Water for Injection is limited to distillation or other processes equivalent or superior to distillation in the removal of chemical impurities as well as microorganisms and their components. Distillation has a long history of reliable performance and can be validated as a unit operation for the production of Water for Injection, but other technologies or combinations of technologies can be validated as being equivalently effective. Other technologies, such as ultrafiltration following other chemical purification process, may be suitable in the production of Water for Injection if they can be shown through validation to be as effective and reliable as distillation. The advent of new materials for older technologies, such as reverse osmosis and ultrafiltration, that allow intermittent or continuous operation at elevated, microbial temperatures, show promise for a valid use in producing Water for Injection.

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Validation plan  Pharmaceutical Water System 

The validation plan should be designed to establish the suitability of the system and to provide a thorough understanding of the purification mechanism, range of operating conditions, required pretreatment, and the most likely modes of failure. It is also necessary to demonstrate the effectiveness of the monitoring scheme and to establish the documentation and qualification requirements for the system’s validation maintenance. Trials conducted in a pilot installation can be valuable in defining the operating parameters and the expected water quality and in identifying failure modes. However, qualification of the specific unit operation can only be performed as part of the validation of the installed operational system. The selection of specific unit operations and design characteristics for a water system should take into account the quality of the feed water, the technology chosen for subsequent processing steps, the extent and complexity of the water distribution system, and the appropriate compendial requirements. For example, in the design of a system for Water for Injection, the final process (distillation or whatever other validated process is used according to the monograph) must have effective bacterial endotoxin reduction capability and must be validated.

INSTALLATION, MATERIALS OF CONSTRUCTION, AND COMPONENT SELECTION

Installation techniques are important because they can affect the mechanical, corrosive, and sanitary integrity of the system. Valve installation attitude should promote gravity drainage. Pipe supports should provide appropriate slopes for drainage and should be designed to support the piping adequately under worst-case thermal and flow conditions. The methods of connecting system components including units of operation, tanks, and distribution piping require careful attention to preclude potential problems. Stainless steel welds should provide reliable joints that are internally smooth and corrosion-free. Low-carbon stainless steel, compatible wire filler, where necessary, inert gas, automatic welding machines, and regular inspection and documentation help to ensure acceptable weld quality. Follow-up cleaning and passivation are important for removing contamination and corrosion products and to re-establish the passive corrosion resistant surface. Plastic materials can be fused (welded) in some cases and also require smooth, uniform internal surfaces. Adhesive glues and solvents should be avoided due to the potential for voids and extractables. Mechanical methods of joining, such as flange fittings, require care to avoid the creation of offsets, gaps, penetrations, and voids. Control measures include good alignment, properly sized gaskets, appropriate spacing, uniform sealing force, and the avoidance of threaded fittings.

Materials of construction should be selected to be compatible with control measures such as sanitizing, cleaning, and passivating. Temperature rating is a critical factor in choosing appropriate materials because surfaces may be required to handle elevated operating and sanitization temperatures. Should chemicals or additives be used to clean, control, or sanitize the system, materials resistant to these chemicals or additives must be utilized. Materials should be capable of handling turbulent flow and elevated velocities without wear of the corrosion-resistant film such as the passive chromium oxide surface of stainless steel. The finish on metallic materials such as stainless steel, whether it is a refined mill finish, polished to a specific grit, or an electropolished treatment, should complement system design and provide satisfactory corrosion and microbial activity resistance as well as chemical sanitizability. Auxiliary equipment and fittings that require seals, gaskets, diaphragms, filter media, and membranes should exclude materials that permit the possibility of extractables, shedding, and microbial activity. Insulating materials exposed to stainless steel surfaces should be free of chlorides to avoid the phenomenon of stress corrosion cracking that can lead to system contamination and the destruction of tanks and critical system components.

Specifications are important to ensure proper selection of materials and to serve as a reference for system qualification and maintenance. Information such as mill reports for stainless steel and reports of composition, ratings, and material handling capabilities for nonmetallic substances should be reviewed for suitability and retained for reference. Component (auxiliary equipment) selection should be made with assurance that it does not create a source of contamination intrusion. Heat exchangers should be constructed to prevent leakage of heat transfer medium to the pharmaceutical water and, for heat exchanger designs where prevention may fail, there should be a means to detect leakage. Pumps should be of sanitary design with seals that prevent contamination of the water. Valves should have smooth internal surfaces with the seat and closing device exposed to the flushing action of water, such as occurs in diaphragm valves. Valves with pocket areas or closing devices (e.g., ball, plug, gate, globe) that move into and out of the flow area should be avoided.

SANITIZATION – Pharmaceutical Water System 

Microbial control in water systems is achieved primarily through sanitization practices. Systems can be sanitized using either thermal or chemical means. Thermal approaches to system sanitization include periodic or continuously circulating hot water and the use of steam. Temperatures of at least 80  are most commonly used for this purpose, but continuously recirculating water of at least 65  has also been used effectively in insulated stainless steel distribution systems when attention is paid to uniformity and distribution of such self-sanitizing temperatures. These techniques are limited to systems that are compatible with the higher temperatures needed to achieve sanitization. Although thermal methods control biofilm development by either continuously inhibiting their growth or, in intermittent applications, by killing the microorganisms within biofilms, they are not effective in removing established biofilms. Killed but intact biofilms can become a nutrient source for rapid biofilm regrowth after the sanitizing conditions are removed or halted. In such cases, a combination of routine thermal and periodic supplementation with chemical sanitization might be more effective. The more frequent the thermal sanitization, the more likely biofilm development and regrowth can be eliminated. Chemical methods, where compatible, can be used on a wider variety of construction materials. These methods typically employ oxidizing agents such as halogenated compounds, hydrogen peroxide, ozone, peracetic acid, or combinations thereof. Halogenated compounds are effective sanitizers but are difficult to flush from the system and may leave biofilms intact. Compounds such as hydrogen peroxide, ozone, and peracetic acid oxidize bacteria and biofilms by forming reactive peroxides and free radicals (notably hydroxyl radicals). The short half-life of ozone in particular, and its limitation on achievable concentrations require that it be added continuously during the sanitization process. Hydrogen peroxide and ozone rapidly degrade to water and oxygen; peracetic acid degrades to acetic acid in the presence of UV light. In fact, ozone’s ease of degradation to oxygen using 254-nm UV lights at use points allow it to be most effectively used on a continuous basis to provide continuously sanitizing conditions.

In-line UV light at a wavelength of 254 nm can also be used to continuously “sanitize” water circulating in the system, but these devices must be properly sized for the water flow. Such devices inactivate a high percentage (but not 100%) of microorganisms that flow through the device but cannot be used to directly control existing biofilm upstream or downstream of the device. However, when coupled with conventional thermal or chemical sanitization technologies or located immediately upstream of a microbially retentive filter, it is most effective and can prolong the interval between system sanitizations.

It is important to note that microorganisms in a well-developed biofilm can be extremely difficult to kill, even by aggressive oxidizing biocides. The less developed and therefore thinner the biofilm, the more effective the biocidal action. Therefore, optimal biocide control is achieved by frequent biocide use that does not allow significant biofilm development between treatments.

Sanitization steps require validation to demonstrate the capability of reducing and holding microbial contamination at acceptable levels. Validation of thermal methods should include a heat distribution study to demonstrate that sanitization temperatures are achieved throughout the system, including the body of use point valves. Validation of chemical methods require demonstrating adequate chemical concentrations throughout the system, exposure to all wetted surfaces, including the body of use point valves, and complete removal of the sanitant from the system at the completion of treatment. Methods validation for the detection and quantification of residues of the sanitant or its objectionable degradants is an essential part of the validation program. The frequency of sanitization should be supported by, if not triggered by, the results of system microbial monitoring. Conclusions derived from trend analysis of the microbiological data should be used as the alert mechanism for maintenance.The frequency of sanitization should be established in such a way that the system operates in a state of microbiological control and does not routinely exceed alert levels (see Alert and Action Levels and Specifications).

 Pharmaceutical Water System OPERATION, MAINTENANCE, AND CONTROL

A preventive maintenance program should be established to ensure that the water system remains in a state of control. The program should include (1) procedures for operating the system, (2) monitoring programs for critical quality attributes and operating conditions including calibration of critical instruments, (3) schedule for periodic sanitization, (4) preventive maintenance of components, and (5) control of changes to the mechanical system and to operating conditions.

Operating Procedures—

Procedures for operating the water system and performing routine maintenance and corrective action should be written, and they should also define the point when action is required. The procedures should be well documented, detail the function of each job, assign who is responsible for performing the work, and describe how the job is to be conducted. The effectiveness of these procedures should be assessed during water system validation.

Monitoring Program—

Critical quality attributes and operating parameters should be documented and monitored. The program may include a combination of in-line sensors or automated instruments (e.g., for TOC, conductivity, hardness, and chlorine), automated or manual documentation of operational parameters (such as flow rates or pressure drop across a carbon bed, filter, or RO unit), and laboratory tests (e.g., total microbial counts). The frequency of sampling, the requirement for evaluating test results, and the necessity for initiating corrective action should be included.

Sanitization—

Depending on system design and the selected units of operation, routine periodic sanitization may be necessary to maintain the system in a state of microbial control. Technologies for sanitization are described above.

Preventive Maintenance—

A preventive maintenance program should be in effect. The program should establish what preventive maintenance is to be performed, the frequency of maintenance work, and how the work should be documented.

Change Control—

The mechanical configuration and operating conditions must be controlled. Proposed changes should be evaluated for their impact on the whole system. The need to requalify the system after changes are made should be determined. Following a decision to modify a water system, the affected drawings, manuals, and procedures should be revised.

Auxiliary Information— Staff Liaison : Gary E. Ritchie, M.Sc., Scientific Fellow

Expert Committee : (PW05) Pharmaceutical Waters 05

USP29–NF24 Page 3056

Pharmacopeial Forum : Volume No. 30(5) Page 1744

Phone Number : 1-301-816-8353

Pharmaceutical Water System Ppt

Pharmaceutical Water Systems

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Pharmaceutical Water System Design Operation And Validation Pdf

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Pharmaceutical Water Systems: Types: Water quality specifications

Pharmaceutical Water System: principles for pharmaceutical water systems

Pharmaceutical Water System PPT – What Is Pharmaceutical Water – Principles PDF

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Pharmaceutical Water System PPT - What Is Pharmaceutical Water - Principles PDF

Water is the most widely used substance, raw material or starting material in the production, processing and formulation of pharmaceutical products. It has unique chemical properties due to its polarity and hydrogen bonds. This means it is able to dissolve, absorb, adsorb or suspend many different compounds. These include contaminants that may represent hazards in themselves or that may be able to react with intended product substances, resulting in hazards to health.

Pharmaceutical Water System Ppt – What Is Pharmaceutical Water

Water is used as ingredient, and solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical ingredients (APIs) and intermediates, compendial articles, and analytical reagents. This general information chapter provides additional information about water, its quality attributes that are not included within a water monograph, processing techniques that can be used to improve water quality, and a description of minimum water quality standards that should be considered when selecting a water source.

Pharmaceutical water includes different types of water used in the manufacture of drug products.

THE 8 TYPES OF WATER ARE:

Non-potable
Potable (drinkable) water
USP purified water
USP water for injection (WFI)
USP sterile water for injection
LUSP sterile water for inhalation
USP bacteriostatic water for injection
USP sterile water for irrigation

Control of the chemical purity of these waters is important and is the main purpose of the monographs in this compendium. Unlike other official articles, the bulk water monographs (Purified Water and Water for Injection) also limit how the article can be produced because of the belief that the nature and robustness of the purification process is directly related to the resulting purity. The chemical attributes listed in these monographs should be considered as a set of minimum specifications. More stringent specifications may be needed for some applications to ensure suitability for particular uses. Basic guidance on the appropriate applications of these waters is found in the monographs and is further explained in this chapter.

Control of the microbiological quality of water is important for many of its uses. All packaged forms of water that have monograph standards are required to be sterile because some of their intended uses require this attribute for health and safety reasons. USP has determined that a microbial specification for the bulk monographed waters is inappropriate and has not been included within the monographs for these waters. These waters can be used in a variety of applications, some requiring extreme microbiological control and others requiring none. The needed microbial specification for a given bulk water depends upon its use.

Pharmaceutical Water System PPT - What Is Pharmaceutical Water - Principles PDF

A single specification for this difficult-to-control attribute would unnecessarily burden some water users with irrelevant specifications and testing. However, some applications may require even more careful microbial control to avoid the proliferation of microorganisms ubiquitous to water during the purification, storage, and distribution of this substance. A microbial specification would also be inappropriate when related to the “utility” or continuous supply nature of this raw material. Microbial specifications are typically assessed by test methods that take at least 48 to 72 hours to generate results. Because pharmaceutical waters are generally produced by continuous processes and used in products and manufacturing processes soon after generation, the water is likely to have been used well before definitive test results are available.

Failure to meet a compendial specification would require investigating the impact and making a pass/fail decision on all product lots between the previous sampling’s acceptable test result and a subsequent sampling’s acceptable test result. The technical and logistical problems created by a delay in the result of such an analysis do not eliminate the user’s need for microbial specifications. Therefore, such water systems need to be operated and maintained in a controlled manner that requires that the system be validated to provide assurance of operational stability and that its microbial attributes be quantitatively monitored against established alert and action levels that would provide an early indication of system control.

Pharmaceutical Water System PPT – What Is Pharmaceutical Water – Principles PDF

Important Notes on Pharmaceutical Water Systems

  1. Control of the quality of water throughout the production, storage and distribution processes, including  microbiological and chemical quality, is a major concern. Unlike other product and process ingredients, water is usually drawn from a system on demand, and is not subject to testing and batch or lot release before use. Assurance of quality to meet the on-demand expectation is, therefore, essential. Additionally, certain microbiological tests may require periods of incubation and, therefore, the results are likely to lag behind the water use.
  2. Control of the microbiological quality of WPU is a high priority. Some types of microorganism may proliferate in water treatment components and in the storage and distribution systems. It is crucial to minimize microbial contamination by proper design of the system, periodic sanitization and by taking appropriate measures to prevent microbial proliferation.
  3. Different grades of water quality are required depending on the route of administration of the pharmaceutical products. Other sources of guidance about different grades of water can be found in pharmacopoeias and related documents.

Pharmaceutical Water System: Principles For Pharmaceutical Water Systems

 

  • Pharmaceutical water production, storage and distribution systems should be designed, installed, commissioned, qualified and maintained to ensure the reliable production of water of an appropriate quality. It is necessary to validate the water production process to ensure the water generated, stored and distributed is not beyond the designed capacity and meets its specifications.
  • The capacity of the system should be designed to meet the average and the peak slow demand of the current operation. If necessary, depending on planned future demands, the system should be designed to permit increases in the capacity or designed to permit modification. All systems, regardless of their size and capacity, should have appropriate recirculation and turnover to assure the system is well controlled chemically and microbiologically.
  • The use of the systems following initial validation (installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ)) and after any planned and unplanned maintenance or modification work should be approved by the quality assurance (QA) department using change control documentation.
  • Pharmaceutical Water System PPT – What Is Pharmaceutical Water – Principles PDF Doc
  • Water sources and treated water should be monitored regularly for chemical, microbiological and, as appropriate, endotoxin contamination. The performance of water purification, storage and distribution systems should also be monitored. Records of the monitoring results, trend analysis and any actions taken should be maintained.
  • Where chemical sanitization of the water systems is part of the biocontamination control programme a validated procedure should be followed to ensure that the sanitizing process has been effective and that the sanitizing agent has been effectively removed.

Pharmaceutical Water Systems: Pharmaceutical Water Storage & Distribution Systems [PDF PPT]

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Pharmaceutical Water Systems Pharmaceutical Water Storage & Distribution Systems [PDF PPT]

Water storage and distribution systems

Pharmaceutical Water Systems:: Water storage and distribution systems applies to WPU systems for PW, BHPW and BWFI. The water storage and distribution should work in conjunction with the purification plant to ensure delivery of water of consistent quality to the user points, and to ensure optimum operation of the water purification equipment.

General Principles of Water storage and distribution systems of Pharmaceutical Water Systems:

  1. The storage and distribution system should be considered as a key part of the whole system and should be designed to be fully integrated with the water purification components of the system.
  2. Once water has been purified using an appropriate method it can either be used directly or, more frequently, it will be fed into a storage vessel for subsequent distribution to points of use. The the requirements for storage and distribution systems and point of use fflPOU) is provided below.
  3. The storage and distribution system should be configured to prevent microbial proliferation and recontamination of the water fflPW, BHPW, BWFI) treatment. It should be subjected to a combination of online and offline monitoring to ensure that the appropriate water specification is maintained.

2 Materials that come into contact with systems for water for pharmaceutical use in Pharmaceutical Water Systems:

Here we deal with generation equipment for PW, BHPW and BWFI and the associated storage and distribution systems.

2.2 The materials that come into contact with WPU, including pipework, valves and fittings, seals, diaphragms and instruments, should be selected to satisfy the following objectives.

Compatibility.

The compatibility and suitability of the materials should encompass the full range of its working temperature and

potential chemicals that will come into contact with the system at rest, in operation and during sanitization.

Prevention of leaching.

All materials that come into contact with WPU should be non-leaching at the range of working and sanitization

temperatures of the system.

Corrosion resistance.

PW, BHPW and BWFI are highly corrosive. To prevent failure of the system and contamination of the water, the materials selected must be appropriate, the method of jointing must be carefully controlled and all fittings and components must be compatible with the pipework used. Appropriate sanitary specification plastics and stainless-steel materials are acceptable for WPU systems. When stainless steel is used it should be at least grade 316. In general 316L or a higher grade of stainless steel is used. The system should be passivated after initial installation or after significant modification. When accelerated passivation is undertaken the system should be thoroughly cleaned first and the passivation process should be undertaken in accordance with a clearly defined documented procedure.

Smooth internal Finish.

Once water has been purified it is susceptible to microbiological contamination and the system is subject to the formation of biofilms when cold storage and distribution are employed. Smooth internal surfaces help to avoid roughness and crevices within the WPU system. Crevices can be the source of contamination because of possible accumulation of microorganisms and formation of biofilms. Crevices are also frequently sites where corrosion can commence. The internal material finish should have an arithmetical average surface roughness of not greater than 0.8 micrometre fflRa). When stainless steel is used, mechanical and electro-polishing techniques may be employed. Electro-polishing improves the resistance of the stainless-steel material to surface corrosion.

Jointing.

The selected system materials should be easily joined by welding in a controlled manner. The control of the process should include, as a minimum, qualification of the operator, documentation  of the welder set-up, work session test pieces logs of all welds and visual inspection of a defined proportion of welds, e.g. 100ft hand welds, 10ft automatic welds.

Documentation.

All system components should be fully documented and be supported by original or certified copies of material certificates.

Materials used for Pharmaceutical Water Systems:

Suitable materials that may be considered for sanitary elements of the system include 316L ffllow carbon) stainless steel, polypropylene, polyvinylidene-diFluoride and perFluoroalkoxy. The choice of material should take into account the intended sanitization method. Other materials such as unplasticized polyvinyl-chloride ffluPVC) may be used for treatment equipment designed for less pure water such as ion exchangers and softeners.

None of the materials that come into contact with WPU should contain chemicals that will be extracted by the water. Plastics should be non-toxic and should be compatible with all chemicals used. They should be manufactured from materials that should at least meet minimum food grade standards. Their chemical and biological characteristics should meet any relevant pharmacopoeia specifications or recommendations. Precautions should be taken to define operational limits for areas where water circulation is reduced and turbulent Flow cannot be achieved. Minimum Flow rate and change volumes should be defined.

3. System sanitization and bioburden control -Pharmaceutical Water Systems:

1 Water treatment equipment, storage and distribution systems used for BPW, BHPW and BWFI should be provided with features to control the proliferation of microbiological organisms during normal use, as well as techniques for sanitizing the system after intervention for maintenance or modification. The techniques employed should be considered during the design of the system and should take into account the interdependency between the materials and the sanitization techniques.

2 Systems that operate and are maintained at elevated temperatures ffle.g. > 65) are generally less susceptible to microbiological contamination than systems that are maintained at lower temperatures. When lower temperatures are required due to the water treatment processes employed or the temperature requirements for the water in use, special precautions should be taken to prevent the ingress and proliferation of microbiological contaminants fflsee section 6.4.3 for guidance).

4 Storage vessel requirements -Pharmaceutical Water Systems:

1 General

1 The water storage vessel used in a system serves a number of important functions. The design and size of the vessel should take into consideration the following.

2 Capacity

1 The capacity of the storage vessel should be determined on the basis of the following requirements:

It is necessary to provide a buffer capacity between the steady-state generation rate of the water-treatment equipment and the potentially variable simultaneous demand from user points.

The water-treatment equipment should be able to operate continuously for significant periods to avoid the equipment stress that occur when the equipment cycles on and off too frequently.

The capacity should be suffcient to provide short-term reserve capacity in the event of failure of the water-treatment equipment or inability to produce water due to a sanitization or regeneration cycle. When determining the size of such reserve capacity, consideration should be given to providing suffcient water to complete a process batch, work session, tank turnover by recirculation to minimize stagnation, or other logical period of demand.

3 Contamination control considerations -Pharmaceutical Water Systems:

The following should be taken into account for the efficient control of contamination:

) The headspace in the storage vessel is an area of risk where water droplets and air can come into contact at temperatures that encourage the proliferation of microbiological organisms. The use of spray-ball or distributor devices should be considered in these systems to wet the surfaces during normal operation, chemical and/or thermal sanitization.

) Nozzles within the storage vessels should be configured to avoid dead zones where microbiological contamination might be harboured.

) Vent filters are fitted to storage vessels to allow the internal level of liquid to Fluctuate. The filters should be bacteria-retentive, hydrophobic and should ideally be configured to allow in situ testing of integrity. Offline testing is also acceptable. The use of heated vent filters should be considered for continuous hot storage or systems using periodic heat sanitization to prevent condensation within the filter matrix that might lead to filter blockage and to microbial growth that could contaminate the storage vessels.

) Where pressure-relief valves and bursting discs are provided on storage vessels to protect them from under- and over-pressurization, these devices should be of a sanitary design. Bursting discs should be provided with external rupture indicators to ensure that loss of system integrity is detected.

Requirements for water distribution pipework -Pharmaceutical Water Systems:

General

The distribution of BPW, BHPW and BWFI should be accomplished using  a continuously circulating pipework loop. Proliferation of contaminants within the storage tank and distribution loop should be controlled. Good justification for using a non-recirculating one-way system should be provided.

2 Filtration should not usually be used in distribution loops or at take off-user points to control biocontamination. Such filters are likely to conceal system contamination.

Temperature control and heat exchangers

Where heat exchangers are employed to heat or cool WPU within a system, precautions should be taken to prevent the heating or cooling utility from contaminating the water. The more secure types of heat exchangers of the double tube plate or double plate and frame or tube and shell configuration should be considered. Where these types are not used, an alternative approach whereby the utility is maintained and monitored at a lower pressure than the WPU may be considered. The latter approach is not usually adopted in BWFI systems.

Where heat exchangers are used they should be arranged in continually circulating loops or subloops of the system to avoid unacceptable static water in systems.

When the temperature is reduced for processing purposes the reduction should occur for the minimum necessary time. The cooling cycles and their duration should be proven satisfactory during the qualification of the system.

Pharmaceutical Water Systems Pharmaceutical Water Storage & Distribution Systems [PDF PPT]

3 Circulation pumps

Circulation pumps should be of a sanitary design with appropriate seals that prevent contamination of the system. Where stand-by pumps are provided, they should be configured or managed to avoid dead zones trapped within the system.

Consideration should be given to preventing contamination in systems where parallel pump systems are used, especially if there is stagnant water when one of the pumps is not being used.

4 Biocontamination control techniques

1 Water purification systems should be sanitized using chemical or thermal sanitization procedures as appropriate fflproduction and distribution). The procedure and conditions used fflsuch as times and temperatures) should be suitable.

2 The following control techniques may be used alone or more commonly in combination:

maintenance of continuous turbulent flow circulation within water distribution systems reduces the propensity for the formation of biofilms the system design should ensure the shortest possible length of pipework;

) for ambient temperature systems, pipework should be isolated from adjacent hot pipes;

) dead legs in the pipework should be minimized through appropriate design, and as a guide should not significantly exceed three times the branch diameter as measured from the ID pipe wall to center line of the point-of-use valve where significant stagnation potential exists;

) pressure gauges should be separated from the system by membranes;

) hygienic pattern diaphragm valves should be used;

) pipework for steam-sanitized systems should be sloped and fully drainable;

) the growth of microorganisms can be inhibited by:

– ultraviolet radiation sources in pipework;

– maintaining the system heated fflgreater than 65 °C);

– sanitizing the system periodically using hot water guidance temperature > 70’°C);

– sanitizing the system periodically using superheated hot water or clean steam;

– routine chemical sanitization using ozone or other suitable chemical agents. When chemical sanitization is used, it is essential to prove that the agent has been removed prior to using the water. Ozone can be effectively removed by using ultraviolet radiation.

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Top Pharmacy Colleges In Andhra Pradesh & Telangana 10 Best

Top Pharmacy Colleges In Andhra Pradesh & Telangana

There are zillions of Pharmacy colleges in Andhra Pradesh & Telangana that are offering are performing excellence in providing B. Pharmacy courses to the pharmacy seeking students.  Students are showing more interest in studying pharmacy, which is why the number of Pharmacy colleges is also increasing time by time.  There are many named Pharmacy colleges and Universities in the state of Andhra Pradesh & Telangana that offer best quality education in Pharmacy to the students.  All the pharmacy colleges and universities are offering various pharmacy courses from under graduation level to post graduation level.

For the students who are searching for best Pharmacy colleges and Universities in the state of Andhra Pradesh & Telangana to join Pharmacy, this article can help you a great deal.  We have gathered up some information about the best and top Pharmacy colleges in Andhra Pradesh & Telangana.  Students who took entrance examination to enter the field of Pharmacy can check our top 10 list to know the near and best colleges to study Pharmacy.  All the colleges and Universities we are going to enlist will provide both under graduation and post graduation courses.

The courses offered by these Universities and Colleges in Andhra Pradesh & Telangana include M. Pharmacy Diploma in Pharmacy (D. Pharmacy), which is a two year course, Bachelor of Pharmacy (B. Pharmacy), which is a four year course, and Pharm.D, which is a six year course.  The Pharmacy Council of India (PCI) is a statutory body that governs the Pharmacy education in the country.  There are many pharmacy qualifications that are regulated by the Pharmacy Act 1948.

Top Pharmacy Colleges In Andhra Pradesh & Telangana 10 Best

Top 10 Pharmacy Colleges in Andhra Pradesh & Telangana

  1. NIPER,Hyderabad {Best Pharmacy Colleges In Andhra Pradesh & Telangana}

National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad is an institute of National importance.  It is the top one institute in Andhra Pradesh & Telangana.  It is headquartered in Mohali and later six branches of NIPER were established all over the country.  It offers two year M.S. (Pharm), M.B.A (Pharm), M.Tech (Pharm) courses and Ph.D programmes.

  1. Pulla Reddy College of Pharmacy, Hyderabad {Top 2 Pharmacy Colleges In Andhra Pradesh & Telangana}
  2. Pulla Reddy College of Pharmacy is established in the year 1994. It is located in Mehdipatnam, Hyderabad. It works with a vision to envisage becoming the center of excellence for research in Pharmacy.  It aims to contribute significantly to drug development and drug discovery.

  3. Deccan School of Pharmacy, Hyderabad {Good Pharmacy Colleges In Andhra Pradesh & Telangana}

Deccan School of Pharmacy has spectra of institutions in Hyderabad.  It offers various programs like Pharmacy, Medical, Engineering, Nursing, Management, Physiotherapy and so on.  It works towards imparting quality education to the needy in various disciplines.

  1. Vaagdevi College of Pharmacy, Warangal {4th in List of Pharmacy Colleges In Andhra Pradesh & Telangana}

Vaagdevi College of Pharmacy was established in 1997 with a motive to develop a premier educational institution to meet the requirements of pharmaceutical industry and health care profession.  It is affiliated to Kakatiya University, Warangal.  It offers highest standards of education to the students studying under it.

  1. Yalamarty B. Pharmacy College, Visakhapatnam {Pharmacy Council of India approved colleges in Andhra Pradesh}

Yalamarty B. Pharmacy College, Visakhapatnam was established in 2004 by Yalamarty.  It is approved by All India Council of Technical Education (AICTE), New Delhi and Pharmacy Council of India (PCI).  Its main objective is to provide quality education and training to the students.

  1. Vignan’s Institute of Pharmaceutical Sciences, Nalgonda {Top Pharmacy Colleges in Telangana}

Vignan Institute of Pharmaceutical Sciences was established in 1999.  It is affiliated to JNTUH.  It philosophy of the college is to provide high quality pharmaceutical sciences education.  It aims to be on forefront in imparting the quality pharmacy education in graduate level.

  1. Rao’s College of Pharmacy, Nellore {Top Pharmacy Colleges In AP}

Rao’s College of Pharmacy was started in the year 2004 under the management of Sanjeevani Arts and Science College Committee.  Its vision is to enlighten the institute in the Galaxy of Business Schools by producing dynamic Kautilyas to control and direct our National Resources in a most efficient manner.  To meet the criteria of innovation, novelty, relevance and application of teaching practice.

  1. RIPER, Anantapur {Government approved Pharmacy Colleges In Andhra Pradesh}

Rghavendra Institute of Pharmaceutical Education and Research (RIPER) is a premier educational institute in Andhra Pradesh & Telangana.  It is one of the top institutes that offer Pharmacy education to the students in Diploma and Doctoral degree.  This institute is affiliated to Jawaharlal Nehru Technological University Ananthapur, Andhra Pradesh & Telangana.

  1. V.S.R Siddartha College of Pharmaceutical Sciences, Vijayawada {PCI approved Pharmacy Colleges In Andhra Pradesh}

KVSR Siddartha College of Pharmaceutical Sciences was established in 1994.  It is affiliated to Acharya Nagarjuna University and from 2010 is affiliated to Krishna University.  It offers under graduation, post graduation and six year Pharm D degree programmes.

  1. Bapatla College of Pharmacy {Top Doctor of pharmacy colleges in Andhra Pradesh}

The Bapatla College of Pharmacy is one of the first private pharmacy colleges established in the year 1995 with Diploma and Degree in Pharmacy.  It is affiliated to JNTUK.  It offers various courses of Pharmacy for the students and is very much named college.

 

Indian Pharmaceutical Industry Overview Analysis 2018 {PDF PPT}

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Indian Pharmaceutical Industry Overview Analysis 2018 {PDF PPT}

Indian pharmaceutical industry Overview and Analysis 2018 PDF PPT is now here ready for you to have a glance. The Indian pharmaceuticals market is the next biggest concerning quantity and thirteenth largest concerning value, according to a report by Equity Master. India is the biggest provider of generic medications internationally using all the Indian generics accounting for 20 percent of global exports concerning volume. Naturally, consolidation is now a significant feature of the Indian pharmaceutical marketplace as the business is extremely fragmented.
India enjoys a significant position in the worldwide pharmaceuticals sector. The nation also has a huge pool of engineers and scientists having the capability to steer the business forward to a much greater degree. Currently over 80 percent of these antiretroviral drugs used worldwide to fight AIDS (Acquired Immuno Deficiency Syndrome) are provided by Indian pharmaceutical companies.

Important Points:

  • The pharmaceutical industry in India ranks 3rd in the world terms of volume and 14th in terms of value.India’s cost of production is nearly 33 per cent lower than that of the US
  • Labour costs are 50–55 per cent cheaper than in Western countries. The cost of setting up a production plant in India is 40 per cent lower than in Western countries
  • Cost-efficiency continues to create opportunities for Indian companies in emerging markets & Africa
  • India has a skilled workforce as well as high managerial & technical competence in comparison to its peers in Asia
  • India has the 2nd largest number of USFDA-approved manufacturing plants outside the US
  • India has 2,633 FDA-approved drug products. India has over 546 USFDA-approved company sites, the highest number outside the US

Growing per capita sales of pharmaceuticals in India offers ample opportunities for players in this market
Per capita sales of pharmaceuticals expanded at a CAGR of 17.6 per cent to US$ 33 in 2016
Economic prosperity would improve affordability for generic drugs in the market & improve per capita sales of pharmaceuticals in India

The UN-backed Medicines Patent Pool has signed six sub-licences with Aurobindo, Cipla, Desano, Emcure, Hetero Labs and Laurus Labs, allowing them to make generic anti-AIDS medicine TenofovirAlafenamide (TAF) for 112 developing countries.

Indian Pharmaceutical Industry Overview Analysis 2018 {PDF PPT}

Present Indian Pharma Industry Scenario

The Indian pharma industry, which is expected to grow over 15 per cent per annum between 2015 and 2020, will outperform the global pharma industry, which is set to grow at an annual rate of 5 per cent between the same period!. The market is expected to grow to US$ 55 billion by 2020, thereby emerging as the sixth largest pharmaceutical market globally by absolute size, as stated by Mr Arun Singh, Indian Ambassador to the US. Branded generics dominate the pharmaceuticals market, constituting nearly 80 per cent of the market share (in terms of revenues). The sector is expected to generate 58,000 additional job opportunities by the year 2025. *
India’s pharmaceutical exports stood at US$ 16.4 billion in 2016-17 and are expected to grow by 30 per cent over the next three years to reach US$ 20 billion by 2020, according to the Pharmaceuticals Export Promotion Council of India (PHARMEXCIL).

Indian companies & Approvals:

Indian companies received 55 Abbreviated New Drug Application (ANDA) approvals and 16 tentative approvals from the US Food and Drug Administration (USFDA) in Q1 of 2017. The USFDA approvals are expected to cross 700 ANDA in 2017, thereby recording a year-on-year growth of 17 per cent. The country accounts for around 30 per cent (by volume) and about 10 per cent (value) in the US$ 70-80 billion US generics market.

India’s biotechnology industry comprising bio-pharmaceuticals, bio-services, bio-agriculture, bio-industry and bioinformatics is expected grow at an average growth rate of around 30 per cent a year and reach US$ 100 billion by 2025. Biopharma, comprising vaccines, therapeutics and diagnostics, is the largest sub-sector contributing nearly 62 per cent of the total revenues at Rs 12,600 crore (US$ 1.89 billion).

Indian Pharma Industry Investments:

The Union Cabinet has given its nod for the amendment of the existing Foreign Direct Investment (FDI) policy in the pharmaceutical sector in order to allow FDI up to 100 per cent under the automatic route for manufacturing of medical devices subject to certain conditions.

The drugs and pharmaceuticals sector attracted cumulative FDI inflows worth US$ 14.71 billion between April 2000 and March 2017, according to data released by the Department of Industrial Policy and Promotion (DIPP).

Major investments in Indian pharmaceutical Sector:

Indian pharmaceutical firm, Eric Lifesciences Pvt Ltd, has launched its initial public offering (IPO) worth Rs 2,000 crore (US$ 311 million) in June 2017.

Indian pharmaceutical company, Cadila Healthcare Ltd, is planning to raise Rs 1,000 crore (US$ 155 million) via a qualified institutional placement (QIP) of shares shortly.

Capital International Group, a private equity fund, has acquired a three per cent stake in Intas Pharmaceuticals Ltd from ChrysCapital Llc for a consideration of US$ 107 million, thereby valuing Intas Pharma at approximatively US$ 3.5 billion.

Aurobindo Pharma Ltd, has acquired four biosimilar products from Swiss firm TL Biopharmaceutical AG, which will require TL Biopharmaceutical to supply all the developmental data for four molecules, which will be developed, commercialised and marketed by Aurobindo Pharma

Piramal Enterprises Ltd acquired a portfolio of spasticity and pain management drugs from UK-based specialty biopharmaceutical company Mallinckrodt Pharmaceuticals, in an all-cash deal for Rs1,160 crore (US$ 171 million).
Aurobindo Pharma has bought Portugal based Generis Farmaceutica SA, a generic drug company, for EUR 135 million (US$ 144 million).

Sun Pharmaceutical Industries Ltd, India’s largest drug maker, has entered into an agreement with Switzerland-based Novartis AG, to acquire the latter’s branded cancer drug Odomzo for around US$ 175 million.
Kedaara Capital Advisors LLP, a private equity (PE) firm, plans to invest Rs 430 crore (US$ 64.5 million) to acquire a minority stake in Hyderabad-based diagnostics chain Vijaya Diagnostic Centre Pvt Ltd.
Sun Pharmaceuticals Industries Limited plans to acquire 85.1 per cent stake in Russian company Biosintez for US$ 24 million for increasing its presence in Russia through local manufacturing capability.
Abbott Laboratories, a global drug maker based in US, plans to set up an innovation and development center (I&D) in Mumbai, which will help in developing new drug formulations, new indications, dosing, packaging and other differentiated offerings for Abott’s global branded generics business.

Indian Government in Indian Pharma Sector:

The Indian government has taken many steps to reduce costs and bring down healthcare expenses. Speedy introduction of generic drugs into the market has remained in focus and is expected to benefit the Indian pharmaceutical companies. In addition, the thrust on rural health programme, lifesaving drugs and preventive vaccines also augurs well for the pharmaceutical companies.
The implementation of the Goods and Services Tax (GST) is expected to be a game-changer for the Indian Pharmaceuticals industry. It will lead to tax-neutral inter-state transactions between two dealers, thereby reducing the dependency on multiple states and increasing the focus on regional hubs. It is expected to result in an efficient supply chain management, which is expected to reduce its cost considerably. The cost of technology and investment is expected to reduce on account of tax credit which can be availed now on the duties levied on import of costly machinery and equipment.

Click below to view:

Indian Pharmaceutical Industry Overview Analysis 2018 {PDF PPT}

Pharma Vision 2020:

Some of the initiatives taken by the government to promote the pharmaceutical sector in India are as follows:
The Government of India unveiled ‘Pharma Vision 2020’ aimed at making India a global leader in end-to-end drug manufacture. Approval time for new facilities has been reduced to boost investments.
The government introduced mechanisms such as the Drug Price Control Order and the National Pharmaceutical Pricing Authority to deal with the issue of affordability and availability of medicines.
Mr Ananth Kumar, Union Minister of Chemicals and Petrochemicals, has announced setting up of chemical hubs across the country, early environment clearances in existing clusters, adequate infrastructure, and establishment of a Central Institute of Chemical Engineering and Technology.
Road Ahead

Future Indian pharmaceutical market:

The Indian pharmaceutical market size is expected to grow to US$ 100 billion by 2025, driven by increasing consumer spending, rapid urbanisation, and raising healthcare insurance among others.
Going forward, better growth in domestic sales would also depend on the ability of companies to align their product portfolio towards chronic therapies for diseases such as such as cardiovascular, anti-diabetes, anti-depressants and anti-cancers that are on the rise.

Exchange Rate Used: INR 1 = US$ 0.0155 as on June 20, 2017.

Indian Pharmaceutical Industry Overview Analysis 2018 PPT}

References:

Consolidated FDI Policy, Department of Industrial Policy & Promotion (DIPP), Press Information Bureau (PIB), Media Reports, Pharmaceuticals Export Promotion Council
Note: ! – According to a study by UBM India, the Indian arm of London-based media and events company; * – According to IIHMR University, Jaipur.

Source :www.ibef.org

 

B. Pharmacy First Year Books List – Subject Notes Books PDF

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B. Pharmacy First Year Books List - Subject Notes Books PDF

B. Pharmacy First Year Books List

Here we are providing the list of books that are needed for the Pharmacy students and the links for downloading the books. Are you just tired in search of finding the First year Pharmacy books then you are up to the right place. We will provide you the cent percent correct information here and you can know all the information that you want here. In the first year course of the Pharmacy students, there are two semesters. A semester is a 6 months course and the year is divided into two semesters. Students will have the books and syllabus to be followed for a particular semester in the year.

Do you know What are the subjects of B.Pharma first semester? B.pharmacy first semester subjects are Pharamaceutics, Pharamaceutical inorganic chemistry,physics.computer programming mathematics and graphics,mathematics and statistics then your having four lab

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B. Pharmacy First Year Books List - Subject Notes Books PDF

Pharmacy First Semester Books for First Year Students:

          In the first semester of the Pharmacy, you will have 9 subjects of which 5 are theory oriented and the remaining 4 are for labs. Following table shows the first semester books for the students:

S.No Subject T P Credits
1 English 3 + 1 – 3
2 Remedial Mathematics/Remedial Biology 3/2 + 1 – 3/2
3 Human Anatomy & Physiology – I 3 + 1 – 3
4 Dispensing Pharmacy & Ethics 3 + 1 – 3
5 Pharmaceutical Organic Chemistry-I 3 + 1 – 3
6 English Communications Skills Lab – 3 2
7 Remedial Biology Lab – 2 0/1
8 Dispensing Pharmacy Lab – 3 2
9 Pharmaceutical Organic Chemistry-I Lab – 3 2
Total Credits 21

These are the first semester subjects for the students and the books for these subjects to be followed by the students. The prescribed textbooks are:

English:

‘Trail Blazers’ by Orient Black Swan Pvt. Ltd. Publishers

Remedial Mathematics/Remedial Biology:

  1. Intermediate first Year mathematics
  2. Intermediate Second year mathematics, printed and published by Telugu Academy, Himayatnagar, Hyderabad
  3. Pharmaceutical Arithmetic’s by Mohd. Ali CBS publishers and distributor, New Delhi.
  4. Higher Engineering Mathematics by Grewal.

Human Anatomy & Physiology – I:

  1. Tortora, G.J and Anagnodokas, Principles of Anatomy and Physiology, N.P Harper & Row Publishers N.Y
  2. C.C.Chatterjee, Human Physiology.
  3. Ross & Wilson, Anatomy-Physiology in health and illness.
  4. Donald.C Rizzo, Fundamental of Anatomy and Physiology.

DISPENSING PHARMACY & ETHICS:

  1. Cooper & Gunns Dispensing Pharmacy, CBS, Publ. and Distributors New Delhi.
  2. R.M Metha, Dispensing Pharmacy.
  3. NK Jain and GD Guptha, Modern Dispensing Pharmacy, Pharma Med Press.
  4. Sanmathi BS and Anshu Guptha, Dispensing Pharmacy – A Practical Manual, Pharma Med Press.

PHARMACEUTICAL ORGANIC CHEMISTRY-I:

  1. T.R. Morrison and R.N. Boyd, Organic chemistry, pentice hall of India private limited, New Delhi.
  2. Arun Bahl & Bahl, Advanced Pharmaceutical Organic Chemistry.

Pharmacy Second Semester Books for First Year Students:

          In the second semester of the Pharmacy, you will be having 8 subjects. Of them 5 subjects are theory oriented and the remaining 3 are labs. Here the following table shows the subjects by specifying their credits too:

S.No Subject T P Credits
1 Human Anatomy & Physiology – II 3 + 1 – 3
2 Pharmacy Inorganic Chemistry 3 + 1 – 3
3 Pharmacy Organic Chemistry – II 3 + 1 – 3
4 Physical Pharmacy – I 3 + 1 – 3
5 Computer Applications & Biostatistics 3 + 1 – 3
6 Human Anatomy & Physiology Lab – 3 2
7 Physical Pharmacy – I Lab – 3 2
8 Computer Applications Lab – 3 2
Total Credits 21

These are the subjects that are present in the second semester of the first year Pharmacy. The prescribed textbooks for these subjects are provided given below:

HUMAN ANATOMY & PHYSIOLOGY – II:

  1. Tortora, G.J and Anagnodokas, Principles of Anatomy and Physiology, N.P Harper & Row Publishers N.Y
  2. Ross & Wilson – Anatomy & Physiology in health and illness – Anne Waugh, Allison Grant.
  3. T.S. Ranganathan, A Text book of Human Anatomy.
  4. Human Anatomy and Physiology. C.C Chatterjee.

PHARMACEUTICAL INORGANIC CHEMISTRY:

  1. A.H.Beckett and J.B.Stenlake, Practical pharmaceutical chemistry, Part-I. The Athtone press, University of London, London.
  2. Advanced Inorganic Chemistry by Satya prakash, G.D.Tuli B.PHARMACY 39
  3. Wal Ankita, Wal, Pranay, Rai, Awani Kumar, Inorganic Pharmaceutical Chemistry, New Age International Publishers.

PHARMACEUTICAL ORGANIC CHEMISTRY-II:

  1. T.R.Morrison and R.N.Boyd, Organic chemistry, pentice hall of India private limited, New Delhi.
  2. Arun Bahl & Bahl, Advanced Pharmaceutical Organic Chemistry.

PHYSICAL PHARMACY – I:

  1. Patrick J. Sinko, Martin’s Physical Pharmacy and Pharmaceutical Sciences Fifth Edition.
  2. C.V.S.Subramanyam, Essentials of Physical Pharmacy, Vallabh Prakashan.
  3. E. Shotton and K. Ridgaway, Physical Pharmaceutics, Oxford University Press, London.
  4. S. J Carter, Cooper and Gunn’s Tutorial pharmacy.
  5. B. Pharmacy First Year Books List pdf

COMPUTER APPLICATIONS AND BIOSTATISTICS:

  1. Computer Fundamentals, Anita Goel, Pearson.
  2. Information Technology Workshop, 3e, G Praveen Babu, M V Narayana BS Publications.
  3. Khan & Khan, “Fundamentals of Biostatistics”.
  4. Pranab Kumar Banerjee, “Introduction to Biostatistics”.
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First impression is the best impression as said by elders. You need to score good marks in the first year to lead a happy and peaceful life along with success in your whole college life. Don’t hesitate to write to write us regarding any doubts we are happy to help you. Tell your friends about our website to help them grow in the carriers. there will be more distractions in the first year of your college but still you need to concentrate on your studies. Life will not be a bed of roses on the first here itself but as you to remove the thorns one by one you will see the fruitful year ahead. We wish you all the very best on on your first typing stone of success.

donot leave your concentration for anything. Hope this article about b pharmacy subjects list first year and the syllabus for the first year of B Pharma has helped you. Share your thoughts here on our Pharmawiki website.

[PDF PPT DOC] Pharmaceutical FILTER VALIDATION – Sterile Protocol FDA Guide

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Pharmaceutical FILTER VALIDATION PDF DOC PPT- Sterile Protocol FDA Guide

FILTER VALIDATION

Do you know Pharmaceutical Filter validation importance? Pharmaceutical processes are validated processes to assure a reproducible product  within set specifications. Equally important is the validation of the filters used within the process, especially the sterilizing grade filters, which, often enough, are used before filling or the final processing of the drug product. In its Guideline on General Principles of Process Validation, 1985, and Guideline on Sterile Drug Products Produced by Aseptic Processing, 1987, the FDA makes plain that the validation of sterile processes is required by the manufacturers of sterile products. Sterilizing grade filters are determined by the bacteria challenge test. This test is performed under strict parameters and a defined solution (ASTM F 838-83).

In any case, the FDA nowadays also requires evidence that the sterilizing grade filter will create a sterile filtration, no matter the process, fluid or bioburden, found. This means that bacteria challenge tests have to be performed with the actual drug product, bioburden, if different or known to be smaller than B. diminuta and the process parameters. The reason for the requirement of a product bacteria challenge test is threefold. First, the influence of the product and process parameters to the microorganism has to be tested. There may be cases of either shrinkage of organisms due to a higher osmolarity of the product or prolonged processing times. Second, the filter’s compatibility with the product and the parameters has to be tested. The filter should not show any sign of degradation due to the product filtered. Additionally, rest assurance is required that the filter used will withstand the process parameters; e.g., pressure pulses, if happening, should not influence the filter’s performance.

Third, there are two separation mechanisms involved in liquid filtration: sieve retention and retention by adsorptive sequestration. In sieve retention, the smallest particle or organism size is retained by the biggest pore within the membrane structure. The contaminant will be retained, no matter the process parameters. This is the ideal. Retention

by adsorptive sequestration depends on the filtration conditions. Contaminants smaller than the actual pore size penetrate such and may be captured by adsorptive attachment to the pore wall. This effect is enhanced using highly adsorptive filter materials, for example,

Glassfibre as a prefilter or Polyamide as a membrane. Nevertheless, certain liquid properties can minimize the adsorptive effect, which could mean penetration of organisms. Whether the fluid has such properties and will lower the effect of adsorptive sequestration and may eventually cause penetration has to be evaluated in specific product bacteria challenge tests.

[PDF PPT DOC] FILTER VALIDATION - Sterile Protocol FDA Guide

Before performing a product bacteria challenge test, it has to be assured that the liquid product does not have any detrimental, bactericidal or bacteriostatic, effects on the challenge organisms. This is done utilizing viability tests. The organism is inoculated into the product

to be filtered at a certain bioburden level. At specified times, the log value of this bioburden is tested. If the bioburden is reduced due to the fluid properties, a different bacteria challenge test mode becomes applicable. If the reduction is a slow process, the challenge test will

be performed with a higher bioburden, bearing in mind that the challenge level has to reach 107 per square centimeter at the end of the processing time. If the mortality rate is too high, the toxic substance is either removed or product properties are changed. This challenge fluid is called a placebo. Another methodology would circulate the fluid product through the filter at the specific process parameters as long as the actual processing time would be. Afterwards, the filter is flushed extensively with water and the challenge test, as described in ASTM F838-38, performed. Nevertheless, such a challenge test procedure would be more or less a filter compatibility test.

Besides the product bacteria challenge test, tests of extractable substances or  articulate releases have to be performed. Extractable measurements and the resulting data are available from filter manufacturers for the individual filters. Nevertheless, depending

on the process conditions and the solvents used, explicit extractable tests have to be  performed. These tests are commonly done only with the solvent used with the drug product but not with the drug ingredients themselves, because the drug product usually

covers any extractables during measurement. Such tests are conducted by the validation services of the filter manufacturers using sophisticated separation and detection methodologies, as GC-MS, FTIR, and RP-HPLC. These methodologies are required, due to the fact that the individual components possibly released from the filter have to be identified and quantified. Elaborate studies, performed by filter manufacturers, showed that there is neither a release of high quantities of extractables (the range is ppb to max ppm per 10-inch element) nor have toxic substances been found. Particulates are critical in sterile filtration, specifically of injectables. The USP 24 (United States Pharmacopoeia) and BP (British Pharmacopoeia) quote specific limits of particulate level contaminations for defined particle sizes. These limits have to be kept and, therefore, the particulate release of sterilizing

grade filters has to meet these requirements. Filters are routinely tested by evaluating the filtrate with laser particle counters. Such tests are also performed with the actual product under process conditions to prove that the product, but especially process conditions, do

not result in an increased level of particulates within the filtrate.

Additionally, with certain products, loss of yield or product ingredients due to adsorption shall be determined. For example, preservatives, like  benzalkoniumchloride or chlorhexadine, can be adsorbed by specific filter membranes. Such membranes need to be saturated by the preservative to avoid preservative loss within the actual product. This preservative loss e.g., in contact lens solutions, can be detrimental, due

to long-term use of such solutions. Similarly, problematic would be the adsorption of required proteins within a biological solution. To optimize the yield of such proteins within an application, adsorption trials have to be performed to find the optimal membrane

material and filter construction.

Cases that use the actual product as a wetting agent to perform integrity tests require the evaluation of product integrity test limits. The product can have an influence on the measured integrity test values due to surface tension, or solubility. A lower surface tension,

for example, would shift the bubble point value to a lower pressure and could result in a false negative test. The solubility of gas into the product could be reduced, which could result in false positive diffusive flow tests. Therefore, a correlation of the product as a wetting agent to the, water wet values has to be done, according to standards set by the manufacturer of the filter. This correlation is carried out by using a minimum of three filters of three filter lots. Depending on the  product and its variability, one or three product lots are used to perform the correlation. The accuracy of such a correlation is enhanced by automatic integrity test

machines. These test machines measure with highest accuracy and sensitivity and do not rely on human judgement, as with a manual test. Multipoint diffusion testing offers the ability to test the filter’s performance and, especially, to plot the entire diffusive flow graph through the bubble point. The individual graphs for a water-wet integrity test can now be compared to the product wet test and a possible shift evaluated. Furthermore, the multipoint diffusion test enables the establishment of an improved statistical base to determine the product wet versus water-wet limits.

Look out here Pharmaceutical FILTER INTEGRITY TESTING – FDA Guideline on Sterile Drug Products

Pharmaceutical Filter Validation References:

  1. Cooper and Gunn’s. Tutorial Pharmacy by S.J.Carter.
  2. Pharmaceutical engineering; K. Sambamurthy
  3. Pharmaceutical engineering; principles and practices, C.V.S. Subrahmanyam
  4. Encyclopedia of pharmaceutical technology, vol 3, edited by James Swarbrick.
  5. Pikal, M.J.; Lukes, A.L.; Lang, J.E. Thermal decomposition of amorphous beta-lactam antibacterials. J. Pharm. Sci. 1977, 66, 1312–1316.
  6. Pikal, M.J.; Lukes, A.L.; Lang, J.E.; Gaines, K. Quantitative crystallinity determinations of beta-lactam antibiotics by solution calorimetry: correlations with stability. J. Pharm. Sci. 1978, 67, 767–773.
  7. Pikal, M.J.; Dellerman, K.M. Stability testing of pharmaceuticals by high-sensitivity isothermal calorimetry at 25_C: cephalosporins in the solid and aqueous solution states. Int. J. Pharm. 1989, 50, 233–252.
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{PDF PPT DOC} FILTRATION EQUIPMENT – Filtration Mechanism & Types – Adv + Disadvantages

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{PDF PPT DOC} FILTRATION EQUIPMENT – Filtration Mechanism & Types – Adv + Disadvantages deals with details of filtration, filtration equipment,definitions, mechanism of filtration, Classification of filtration equipment, Different types of filtration its advantages & Disadvantages.

FILTRATION Definition:

FILTRATION may be defined as the separation of a solid from a fluid by means of a porous medium that retains the solid but allows the fluid to pass.

The term fluid includes liquids and gases, so that both these may be subjected to filtration.

The suspension of solid and liquid to be filtered is known as the “slurry”. The porous medium used to retain the solids is described as the filter medium; the accumulation of solids on the filter is referred to as the filter cake, while the clear liquid passing through the filter is the filtrate.

2.MECHANISMS OF FILTRATION:

The mechanisms whereby particles are retained by the filter are of significance only in the early stages of liquid filtration, as a rule. Once a preliminary layer of particles has been deposited, the filtration is effected by the filter cake, the filter medium serving only as a support.

STRAINING:

The simplest filtration procedure is “straining”, in which, like sieving, the pores are smaller than the particles, so that the latter are retained on the filter medium.

ENTANGLEMENT:

If the filter medium consists of a cloth with a nap or a porous felt, then particles become entangled in the mass of fibres. Usually the particles are smaller than the pores, so that it is possible that impingement is involved.

ATTRACTIVE FORCES:

In certain circumstances, particles may collect on a filter medium as a result of attractive forces. The ultimate in this method is the electrostatic precipitator, where large potential differences are used to remove the particles from air streams.

In practise, the process may combine the various mechanisms, but the solids removal is effected normally by a straining mechanism once the first complete layers of solids has begun to form the cake on the filter medium.

3.CLASSIFICATION OF THE FILTRATION EQUIPMENT:

Equipment’s are classified based on the application of external force.

  1. Pressure filters: plate and frame filter press and metafilter
  2. Vacuum filters: filter leaf
  3. Centrifugal filters

Classification based on the operation of the filtration

  1. Continuous filtration: discharge and filtrate are separated steadily and uninterrupted
  2. Discontinuous filtration: discharge of filtered solids is intermittent. Filtrate is removed continuously. The operation must be stopped to collect the solids.

Classification based on the nature of filtration

  1. Cake filters: remove large amounts of solids (sludge or crystals)
  2. Clarifying filters: remove small amounts of solids
  3. Cross-flow filters: feed of suspension flows under pressure at a fairly high velocity across the filter medium.

Equipment’s of pharmaceutical interest:

  1. Sand filters:
  2. Filter presses: chamber, plate and frame filters ( non-washing/washing; closed delivery/open delivery)
  3. Leaf filters
  4. Edge filters: stream line and meta filters
  5. Rotary continuous filters
  6. Membrane filters

  1. FILTRATION EQUIPMENT:

  2. {PDF PPT DOC} FILTRATION EQUIPMENT - Filtration Mechanism & Types - Adv + Disadvantages

4.1.SAND FILTERS

 

These are used mainly when relatively small amounts of solid are to be removed from the liquid and when relatively large volumes of liquid must be handled at minimum cost. A standardised pressure sand filter consists of a cylindrical tank at the bottom of which are a number of brass strainers which are either mounted on a false bottom or connected to a manifold embedded in concrete. The strainers have narrow slots sawed in them. Over the strainers is a layer of several inches of moderately coarse gravel on the top of which is a 2 to 4 ft. deep sand layer that forms the actual filter medium. The water to be filtered is introduced at the top on to a baffle which prevents disturbance in the sand by a direct stream. The filtered water is drawn off through the strainers at the bottom. When the precipitate clogs the sand to the extent of retarding the flow of water, it is removed by back washing. This operation consists of introducing water through the strainers, so that it may flow up through the sand bed and-out through the connection that is normally the inlet. This wash water is wasted. These sand filters are applicable only to the separation of precipitates that can be removed from the sand in this manner and that are to be discarded. Gelatinous precipitates or precipitates that coat the sand so that they cannot be removed by back washing or precipitates that are to be recovered cannot be handled in the sand filter.

Capacity is usually 2 to 4 gpm/sq.ft of surface of filtering area.

Fig1: pressure sand filter

For filtering excessively large quantities of very clean water, an open or rapid sand filter is used. It is similar to the pressure sand filter except that the sand is contained in large, open concrete boxes instead of in a closed pressure tank. Sand filter used in this way becomes a gravity filter (also called hydrostatic head filter).

ADVANTAGES:

Gravity filters have advantages of extreme simplicity, needing only simple accessories, low first cost and can be made of almost any material.

DISADVANTAGES:

  • Relatively low rate of filtration.
  • Excessive floor area needed and high labour charges
  • If the amount of particulate matter to be removed is too small or it is finely divided, sand filter will not remove the suspended solids.
  • In processes involving organic materials there may be danger of bacterial infection from an infected process-water supply and the sand filter cannot remove the bacteria as such. In these cases a coagulant like ferrous sulphate or aluminium sulphate is added to the water before filtration. These are hydrolysed by the alkalinity of most normal waters with the formation of a flocculant precipitate of iron or aluminium hydroxide. This precipitate adsorbs finely divided suspended matter and even bacteria, even if added to the water in very small amounts. The resultant flocs, though fine, are removed by the sand filters.

4.2.PLATE AND FRAME FILTER PRESS:

.

Principle : The mechanism is surface filtration. The slurry enters the frame by pressure and flows through the filter medium: The filtrate is collected on the plates and sent to the outlet. A number of frames and plates are used so that surface area increases and consequently large volumes of slurry can be processed simultaneously with or without washing.

Construction .: The construction of a plate and frame filter press is shown in the figure2. The filter press is made of two types of units, plates and frames.

(a) Frame-Maintains the slurry reservoir, inlet (eye) for slurry.

(b) Filter medium.

(c) Plate along with section-supports the filter medium, receiving the filtrate and outlet (eye).. (d) Assemb1y of plate and frame filter press.

These are usually made of aluminium alloy. Sometimes these are also lacquered for protection against corrosive chemicals and made suitable for steam sterilisation.

Frame contains an open space inside wherein the slurry reservoir is maintained for filtration and an inlet to receive the slurry. It is indicated by two dots in the description (Figure ).The plate has a studded or grooved surface to support the filter cloth and an outlet. It is indicated by one dot in the description (Figure ). The filter medium (usually cloth) is interposed between plate and frame.

Frames of different thicknesses are available. It is selected based on the thickness of the cake formed during filtration. Optimum thickness of the frame should be chosen. Plate, filter medium, frame, filter medium and plate are arranged in the sequence and clamped to a supporting structure. It is normally described by dots as 1.2.1.2.1 so on. A number of plates and frames are employed so that filtration area is a large as necessary. In other words, a number of filtration units are operated in parallel. Channels for the slurry inlet and filtrate outlet can be arranged by fitting eyes to the plates and frames, these join together to form a channel. In some types, only one inlet channel is formed, while each plate is having individual outlets controlled by valves.

Working : The working of the frame and plate process can be described in two steps, namely filtration and washing of  the cake (if desirable).

 

Filtration operation : The working of a plate and frame press is shown in Figure. Slurry enters the frame (marked by 2 dots) from the feed channel and passes through the filter medium on to the surface of the plate (marked by I dot). The solids form a filter cake and remain in the frame. The thickness of the cake is half of the frame thickness, because on each side of the frame filtration occur. Thus, two filter cakes are formed, which meet eventually in the centre of the frame. In general, there will be an optimum thickness of filter cake for any slurry, depending on the solid content in the slurry and the resistance -of the

filter cake.

The filtrate drains between the projections on the surface of the plate and escapes from the outlet. As filtration proceeds, the resistance of the cake increase and the filtration rate decreases. At a certain point, is preferable to stop the process rather than continuing at very low flow rates. The press is emptied and the cycle is restarted.

Fig 3: plate and frame filter press

Washing operation: If it is necessary to wash the filter cake, the ordinary plate and frame press is unsatisfactory. Two cakes are built up in the frame meeting eventually in the middle. This means that flow is brought virtually to a stand still. Hence, water wash using the same channels of the filtrate is very inefficient, if not  impossible. A modification of the plate and frame press is used. For this purpose, an additional channel is included (Figure). These wash plates are identified by three dots. In half the wash  plate there is a connection from the wash water channel to the surface of the plate.

The sequence of arrangement of plates and frames can be represented by dQts as 1.2.3.2.1.2.3.2.1.2.3.2.1 so on (between I and 1,2.3.2 must be arranged). Such an arrangement is shown in Figure (a) and (b) for the operations of filtration and water washing, respectively.

The steps are as follows.

(1) Filtration proceeds in the ordinary way until the frames are filled with cake.

(2) To wash the filter cake, the outlets of the washing plates (three dots) are closed.

(3) Wash water is pumped into the washing channel. The water enters through the inlets on to the surface     of the washing (three dots) plates.

(4) Water passes through the filter cloth and enters frame (two dots) which contains the cake. Then water washes the cake, passes through the filter cloth and enters the plate (one dot) down the surface.

(5)Finally washed water escapes through the outlet of that plate.

Fig 4: plate and frame filter press with water wash facility

Thus with the help of special washing plates, it is possible for the wash-water to flow over the entire surface of washing (three dots) plate, so that the flow resistance of the cake is equal to all points. Hence, the entire cake is washed with equal efficiency.

Fig 5: principles of filtration and washing

It should be noted that water- wash is efficient only if the frames are full with filter cake. If the solids do not fill the frame completely, the wash water causes the cake to break (on the washing plate side of the frame) then washing will be less effective. Hence, it is essential to allow the frames become completely filled with the cake. This helps not only in emptying the frames but also helps in washing the cake correctly.

Special provisions:

(I) Any possible contamination can be observed by passing the filtrate through a glass tube or sight glass from the outlet on each plate. This permits the inspection of quality of the filtrate. The filtrate goes through the control valve to an outlet channel.

(2) The filtration process from each plate can be seen. In the event of a broken cloth, the faulty plate can be isolated and filtration can be continued with one plate less.

Uses : Filter sheets composed of asbestos and cellulose are capable of retaining bacteria, so that sterile filtrate can be obtained, provided that the whole filter press and filter medium have been previously sterilized. Usually steam is passed through the assembled unit for sterilization.

Examples include collection of precipitated antitoxin, removal of precipitated proteins from insulin liquors and removal of cell broth from the fermentation medium.

Heating/cooling coils are incorporated in the press so as to make it suitable for the filtration of viscous liquids .

Advantages :

(1) Construction of filter press is very simple and a variety of materials can be used.

– Cast iron for handling common substances.

— Bronze for smaller units.

– Stainless steel is used there by contamination can be avoided.

– Hard rubber or plastics where metal must be avoided.

– Wood for lightness though it must be kept wet.

(2) It provides a large filtering area in a relatively small floor space. It is versatile, the capacity being variable according to the thickness of frames and the number used. Surface area can be increased by employing chambers up to 60.

(3) The sturdy construction permits the use of considerable pressure difference. About 2000 kilopascals can’ be normally used.

(4) Efficient washing of the cake is possible.

(5) Operation and maintenance is straight forward, because there are no moving parts, filter cloths are easily renewable. Since all joints are external, a plate can be disconnected if any leaks are visible. Thus contamination of the filtrate can be avoided.

(6) It produces dry cake in the form of slab.

Disadvantages :

(I)it is a batch filters so there is a good deal of ‘down-time’, which is non-productive.

(2) The filter press is an expensive filter. The emptying time, the labour involved and the wear and tear of the cloth resulting in high costs.

(3)operation is critical, as the frames should be full, otherwise washing is inefficient and the cake is difficult to remove.

(4) The filter press is used for slurries containing less than 5% solids.  So high costs make it  imperative that this filter press is used for expensive materials. Examples include the collection of precipitated antitoxin and removal of precipitated proteins from insulin liquors.

4.3.FILTER LEAF:

The filter leaf is probably the simplest  form, of  filter, consisting of a frame enclosing a drainage screen or grooved  plate, the whole unit being covered with filter cloth. The outlet for the filtrate connects to the inside of the frame. The frame may be of any shape, circular, square or rectangular shapes being used in practice. In use, the filter leaf is

immersed in the slurry’ and a receiver and vacuum system connected to the filtrate outlet. The method has the advantage that the slurry can be filtered from any vessel and the cake can be washed simply by immersing the filter, in a vessel of water. Removal of the cake is facilitated by the use of reverse air flow.

An alternative method is to enclose the filter leaf in a special vessel into which the slurry is pumped under pressure.

This form is commonest in filters where a number of leaves are connected to common outlet, to provide a larger area for filtration. A typical example is “ the Sweetland filters“

Fig 6: filter leaf                                              Fig 7: sweetland filter

The filter leaf is a versatile piece of equipment. Area can be varied by employing a suitable number of units, and the pressure difference may be obtained with vacuum or by using pressures up to order of 8 bars. The leaf filter is most satisfactory if the solids content of slurry is not too high, about 5 per cent being a suitable maximum. A higher proportion, results in excessive non-productive time while the filter being emptied and, provided this is observed. Labour costs for operating the filter are comparatively moderate·

The special feature of the leaf filter is the high efficiency of washing; in fact the cake can be dislodged and refiltred from the wash water if desired.

 

4.4.ROTARY FILTER:

Filters such as the filter leaf and filter press are batch operated and can handle dilute suspensions only, if the process is to be economic. In large scale operation, continuous operation is sometimes desirable and it may be necessary to filter slurries containing a high proportion of solids.

The rotary filter is continuous in operation and has a system for removing the cake that is formed, hence it is suitable for use with concentrated slurries.

The rotary filter consists of a number of filter units (usually 16-20 )  arranged so that the units are passing in continuous succession through the various stages.

One form is the rotary disc filter in which the sectors shaped filter leafs form a disc with the outlet from the each leaf connected to the vacuum system, compressed air, and the appropriate receivers, in the correct sequence, by means of special rotating valve.

fig 8: Rotary drum filter

The commonest form in use in the pharmaceutical industry, however, is the rotary drum filters, a section of which is shown in figure, from which it will be seen that the filter units have the shape of longitudinal segments of the pheriphery of a cylinder. Thus, each filter unit is rectangular in shape with a curved profile so that a number can be joined up to form a drum. Each unit has a perforated metal surface to the outer part of the drum and is covered with filter cloth. Appropriate connections are again made from each unit through a rotating valve at the center of the drum. In operation, the drum rotates at low speed, so that cach unit passes through the various zones shown in figure and listed in table.

Rotary filters may be up to 2m in diameter and 3.5m in length, giving areas of the order of 20m2. Special attachments may be included for special purposes; for example if the cake shrinks and cracks as it dries out, cake compression rollers can be fitted. These compress the cake to a homogenous mass to improve the efficiency of washing as the cake passes through the washing zone, or to aid drainage of wash water as the cake passes to the drying zone.

Where the solids of the slurry are such that the filter cloth becomes blocked with the particles, a pre coat filter may be used. This is variant in which a precoat of filter aid is deposited on the drum prior to the filtration process. The scraper knife then removes the solid filtered from the slurry together with a small amount amount of the precoat, the knife advancing slowly as the precoat is removed.

If the removal of the cake presents the problems, alternative discharge methods can be used. The string discharge rotary filter, for example, is especially useful for certain pharmaceutical applications, particularly for filtering the fermentation liquor in the manufacture of antibiotics where the mould is difficult to filter by ordinary methods because it forms a felt-like cake. The string discharge filter is operated by means of a number of loops of string which pass the drum, and cause the cake to form over the strings as shown in the diagram. The strings are in contact with the surface of the drum up to the cake removal zone, where they leave the surface and pass over additional small rollers before returning to again contact the drum. In operation, the strings lift the filter cake of the filter medium, and the cake is broken by the sharp bend, over the rollers so that it is easily collected while the strings return to the drum.

Advantages:

 

(a) The rotary filter is automatic and is continuous in operation, so that labour costs are very low

(b) the filter has a large capacity, in fact, the area of the filter as represented by A of darcy’s law is infinity.

(c) variation of the speed of rotation enables the cake thickness to be controlled and for solids that form an impermeable cake, the thickness may be limited to less than 5mm. On the other hand, if the solids are coarse, forming a porous cake, the thickness may be 100mm or more.

Table 1: various zones in rotary filter.

Fig 9: string discharge rotary drum filter

Disadvantages:

  • The rotary filter is a complex piece of equipment with many moving parts and is very expensive and in addition to the filter itself, ancillary equipments such as vacuum pumps and vacuum receivers and traps, slurry pumps and agitators are required.
  • The cake tends to crack due to the air drawn through by the vacuum system so that washing and drying are not efficient.
  • Being a vaccum filter the pressure difference is limited to 1 bar and hot filtrates may boil.
  • The rotary filter is suitable only for straight forward slurries,being less satisfactory if the solids formed an impermeable cake or will not separate cleanly from the cloth.

USES OF THE ROTARY FILTERS:

The rotary filter is most suitable for continuous operation on large quantities of slurry, especially if the slurry contains considerable amounts of solids, i.e., in the range 15-30%.

Examples of pharmaceutical applications include the collection of calcium carbonate, magnesium carbonate and starch, and the separation of mycelium from tyhe fermentation liquor in the manufacture of antibiotics.

4.5.MEMBRANE FILTERS:

These are plastic membranes based on cellulose acetate, cellulose nitrate or mixed cellulose esters with pore sizes in the micron or submicron range. They are very thin (about 120 micron thick) and must be handled carefully. They act like a sieve trapping particulate matter on their surface.

Several grades of filters are available with pore sizes ranging from 0.010 ± 0.002

micron to 5.0 ± 1.2 micron. Type codes VF and SM are given by Millipore Filter Corp. for

these two extreme ranges respectively.

Filters with pore sizes from 0.010 to 0.10 micron can remove virus particles from water or air. Filters with pore sizes from 0.30 to 0.65 microns are employed for removing bacteria. Filters with the larger pore sizes, viz. 0.8, 1.2 and 3.0 to 5.0 microns are employed, for example, in aerosol, radio activity and particle sizing applications.

During use membrane filters are supported on a rigid base of perforated metal, plastic or coarse sintered glass as in the case of fibrous pad filters. If the solution to be filtered contains a considerable quantity of suspended matter, preliminary filtration through a suitable depth filter avoids clogging of the membrane filter during sterile filtration. They are brittle when dry and can be stored indefinitely in the dry state but are fairly tough when wet.

ADVANTAGES:

  • No bacterial growth through the filter takes place during prolonged filtration.
  • They are disposable and hence no cross contamination takes place.
  • Adsorption is negligible they yield no fibres or alkali into the filterate. Filtration rate is rapid.

 

DISADVANTAGES:

  • They may clog though rarely.
  • Ordinary types are less resistant to solvents like chloroform

 

4.6.EDGE FILTERS:

A form of filters that differs markedly from those described above is the type known generally as edge filters. Filters such as the leaf or press act by presenting a surface of the filter medium to the slurry. Edge filters use a pack of the filter medium, so that filtration occurs on the edges. Forms using packs of media such as filter paper can be used but in the pharmaceutical industry greatest use is made of the Metafilter.

4.7.METAFILTER:

The metafilter, in its simplest form, consists of a grooved drainage rod on which is packed a series of metal rings. These rings, usually of stainless steel, are about 15mm inside diameter, and 0.8mm in thickness, with a number of semi-circular projections on one surface, as shown in the figure. The height of the projections and the shape of the section of the ring are such as that when the rings are packed together, all the same way up, and tightened on the drainage rod with a nut, channels are formed that taper from about 250µm down to 25µm. One or more of these packs is mounted in a vessel, and the filter may be operated by pumping in the slurry under pressure or, occasionally, by the application of reduced pressure to the outlet side.

In this form, the metafilter can be used as a strainer for coarse particles, but for finer  particles a bed of a suitable material such kieselguhr is first built up. The pack of rings, therefore, serves essentially as a base on which the true filter medium is supported.

Advantages

 

(a) The metafilter possesses considerable strength and high pressures can be used, with no danger of bursting the filter medium.

(b)As there is no filter medium as such, the running costs are low, and it is a very economical

filter.

(c) The metafilter can be made from materials that can provide excellent resistance to corrosion and avoid contamination of the most sensitive product.

(d) by selection of a suitable grade of material to form the bed, it is possible to filter off very fine particles; in fact, it is claimed that some grade will sterilize some liquid by filteration. Equally well it is possible to remove larger particles simply by building up a bed of coarse substances, or even by using the meta filter candle itself if the particles are sufficiently large.

(e) Removal of the cake is effectively carried out by back flushing with water. If further cleaning is required, it is normally necessary to do more than slacken the clamping nut on the end of the drainage rod on which the rings are packed.

Fig:10 (a) surface view ring ,

                                             (b) section through filter

USES OF THE METAFILTER:

 

The small surface of the metafilter restricts the amount of the solids that can be collected. This, together with the ability to separate very fine particles, means that the metafilter is used almost exclusively for clarification purposes.

Furthermore, the strength of the metafilter permits the use of high pressures (15 bars) making the method suitable for viscous liquids. Also, it can be constructed with material appropriate for corrosive materials. Specific examples of pharmaceutical uses include the clarification os syrups, of injection solutions, and of products such as insulin liquors.

CONCLUSION:

Filtration is an unique unit operation. The seperative process of filtration is widely used in the biopharmaceutical industry to remove contaminants from liquids, air, and gases, such as particulate matter, micro organisms. So a thorough knowledge of filtration equipment and their integrity testing is essential.

References:

  1. Cooper and Gunn’s. Tutorial Pharmacy by S.J.Carter.
  2. Pharmaceutical engineering; K. Sambamurthy
  3. Pharmaceutical engineering; principles and practices, C.V.S. Subrahmanyam
  4. Encyclopedia of pharmaceutical technology, vol 3, edited by James Swarbrick.
  5. Pikal, M.J.; Lukes, A.L.; Lang, J.E. Thermal decomposition of amorphous beta-lactam antibacterials. J. Pharm. Sci. 1977, 66, 1312–1316.
  6. Pikal, M.J.; Lukes, A.L.; Lang, J.E.; Gaines, K. Quantitative crystallinity determinations of beta-lactam antibiotics by solution calorimetry: correlations with stability. J. Pharm. Sci. 1978, 67, 767–773.
  7. Pikal, M.J.; Dellerman, K.M. Stability testing of pharmaceuticals by high-sensitivity isothermal calorimetry at 25_C: cephalosporins in the solid and aqueous solution states. Int. J. Pharm. 1989, 50, 233–252
  8. batch and continuous filtration,pharmaceutical filtration ppt, factors affecting rate of filtration, filtration ppt presentation, theory of filtration ppt, advantages and disadvantages of filtration of water,
    rate of filtration calculation, filtration techniques ppt, types filtration equipment, filtration equipment pdf,
    filtration equipment ppt, simple filtration equipment, filtration equipment chemistry, types of filtration process, types of water filtration, types of filtration pdf.

Filtration equipment pdf

filtration equipment pdf,PDF PPT DOC Pharmaceutical FILTRATION EQUIPMENT – Filtration Mechanism & Types – Adv Disadvantages

[PDF] FILTER INTEGRITY TESTING – FDA Guideline on Sterile Drug Products DOC PPT

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FILTER INTEGRITY TESTING

A filter integrity test is a critical unit operation commonly employed in the Pharma industry. FDA Guideline on Sterile Drug Products @ FILTER INTEGRITY TESTING is given below.

FILTER INTEGRITY TESTING

Sterilizing grade filters require testing to assure the filters are integral and fulfill their purpose. Such filter tests are called integrity tests and are performed before and after the filtration process. Sterilizing grade filtration would not be admitted to a process if the filter would not be integrity tested in the course of the process. This fact is also established in several guidelines, recommending the use of integrity testing, pre- and post-filtration. This is not only valid for liquid but also for air filters.

Examples of such guidelines are :

  1. FDA Guideline on Sterile Drug Products Produced by Aseptic Processing (1987):

Normally, integrity testing of the filter is performed after the filter unit is assembled and prior to use. More importantly however, such testing should be conducted after the filter is used in order to detect any filter leaks or perforations that may have occurred during filtration.

  1. The Guide to Inspections of High Purity Water Systems, Guide to Inspections of Lyophilization of Parenterals, and also the CGMP document 212.721 Filters state the following:
  2. The integrity of all air filters shall be verified upon installation and maintained throughout use. A written testing program adequate to monitor integrity of filters shall be established and followed. Results shall be recorded and maintained as specified in 212.83.
  3. Solution filters shall be sterilized and installed aseptically. The integrity of solution filters shall be verified by an appropriate test, both prior to any large-volume parenteral solution filtering operation and at the conclusion of such operation before the filters are discarded. If the filter assembly fails the test at the conclusion of the filtering operation, all materials filtered through it during that filtering operation should be rejected. Rejected materials may be refiltered using filters whose integrity has been verified provided that the additional time required for refiltration does not result in a total process time that exceeds the limitations specified in 212.111. Results of each test shall be recorded and maintained as required in 212.188(a).
  4. ISO 13408-1 First Edition, 1998-08-1, Aseptic Processing of Health Care Products, Part 1: General requirements: Section 17.11.1 Investigation, m. pre- and post-filter integrity test data, and/or filter housing assembly:
  5. 20.3.1. A validated physical integrity test of a process filter shall be conducted after use without disturbing the filter housing assembly. Filter manufacturer’s testing instructions or recommendations may be used as a basis for a validated method. Physical integrity testing of a process filter should be conducted before use where process conditions permit. ‘‘Diffusive Flow,’’ ‘‘Pressure Hold,’’ and ‘‘Bubble Point’’ are acceptable physical integrity tests.
  6. 20.3.2. The ability of the filter or housing to maintain integrity in response to sterilization and gas or liquid flow (including pressure surges and flow variations) shall be determined.
  7. USP 23, 1995, P. 1979. Guide to Good Pharmaceutical manufacturing Practice (Orange

FDA Guide, U.K., 1983):

  1. PDA (Parenteral Drug Association), Technical Report No. 26, Sterilizing Filtration of Liquids (March 1998):

Integrity tests, such as the diffusive flow, pressure hold, bubble point, or water intrusion tests, are non-destructive tests, which are correlated to the destructive bacteria challenge test with 107/cm2 B. diminuta. Derived from these challenge tests, specific integrity test limits are established, which are described and documented within the filter manufacturers’ literature. The limits are water-based; i.e., the integrity test correlations are performed using water as a wetting medium. If a different wetting fluid, such as a filter or membrane configuration, is used, the integrity test limits may vary. Integrity test measurements depend on the surface area of the filter, the polymer of the membrane, the wetting fluid, the pore size of the membrane, and the gas used to perform the test.

Wetting fluids may have different surface tensions, which can depress or elevate the bubble point pressure. The use of different test gases may elevate the diffusive gas flow. Therefore, appropriate filter validation has to be established to determine the appropriate integrity test limits for the individual process. Bubble Point Test Microporous membranes will fill their pores with wetting fluids by imbibing that fluid in accordance with the laws of capillary rise. The retained fluid can be forced from the filter pores by air pressure applied

from the upstream side. The pressure is increased gradually in increments. At a certain pressure level, liquid will be forced first from the set of largest pores, in keeping with the inverse relationship of the applied air pressure P and the diameter of the pore, d, described in the bubble point equation:

where g is the surface tension of the fluid, y is the wetting angle, P is the upstream pressure at which the largest pore will be freed of liquid, and d is the diameter of the largest pore.

When the wetting fluid is expelled from the largest pore, a bulk gas flow will be detected on the downstream side of the filter system (Fig. 7). The bubble point measurement determines the pore size of the filter membrane, i.e., the larger the pore the lower the bubble point pressure. Therefore, filter manufacturers specify the bubble point limits as the minimum allowable bubble point. During an integrity test, the bubble point test has to exceed the set minimum bubble point.

Manual bubble point test set up

 FILTER INTEGRITY TESTING

 

 

 

1.Diffusion Test

A completely wetted filter membrane provides a liquid layer across which, when a differential pressure is applied, the diffusive airflow occurs in accordance with Fick’s law of diffusion. This pressure is called test pressure and commonly specified at 80% of the bubble point pressure. In an experimental elucidation of the factors involved in the process, Reti simplified the integrated form of Fick’s law to read as follows:

where N is the permeation rate (moles of gas per unit time), D is the diffusivity of the gas in the liquid, H is the solubility coefficient of the gas, L is the thickness of liquid in the membrane (equal to the membrane thickness if the membrane pores are completely filled

with liquid), P (p1 _ p2) is the differential pressure, and r is the void volume of the membrane, its membrane porosity, commonly around 80%. The size of pores only enter indirectly into the equation; in their combination, they comprise L, the thickness of the liquid layer, the membrane being some 80% porous. The critical measurement of a flaw is the thickness of the liquid layer. Therefore, a flaw or an oversized pore would be measured by the thinning of the liquid layer due to the elevated test pressure on the upstream side. The pore or defect may not be large enough that the bubble point comes into effect, but the

test pressure thins the liquid layer enough to result into an elevated gas flow. Therefore, filter manufacturers specify the diffusive flow integrity test limits as maximum allowable diffusion value. The larger the flaw or a combination of flaw, the higher the diffusive flow.

Pressure Hold Test:

The pressure hold test is a variant of the diffusive airflow test. The test set-up is arranged as in the diffusion test except that when the stipulated applied pressure is reached, the pressure source is valved off. The decay of pressure within the holder is then observed as a function of time, using a precision pressure gauge or pressure transducer.

The decrease in pressure can come from two sources:

1) the diffusive loss across the wetted filter. Because the upstream side pressure in the  holder is constant, it decreases progressively as all the while diffusion takes place through the wetted membrane and

2) the source of pressure decay could be a leak of the filter system set-up. An  important influence on the measurement of the pressure hold test is the upstream air volume within the filter system. This volume has to be determined first to specify the maximum allowable pressure drop value. The larger the upstream volume, the lower will the pressure drop be. The smaller the upstream volume, the larger the pressure drop. This also means an increase in the sensitivity of the test, and also an increase of temperature influences, if changes occur. Filter manufacturers specify maximum allowable pressure drop values.

2.Water Intrusion Test:

The water intrusion test is used for hydrophobic ventand air membrane filters only. The upstream side of the hydrophobic filter cartridge housing is flooded with water. The water will not flow through the hydrophobic membrane. Air or nitrogen gas pressure is then applied to the upstream side of the filter housing above the water level to a defined test pressure. This is done by way of an automatic integrity tester. A period of pressure stabilization takes place over time frame, by the filter manufacturer’s recommendation, during which the cartridge pleats adjust their positions under imposed pressures.

After the pressure drop thus occasioned stabilizes, the test time starts, and any further pressure drop in the upstream pressurized gas volume, as measured by the automatic tester, signifies a beginning of water intrusion into the largest (hydrophobic) pores, water being incompressible. The automated integrity tester is sensitive enough to detect the pressure drop. This measured pressure drop is converted into a measured intrusion value, which is compared to a set intrusion limit, which has been correlated to the bacteria challenge test. As with the diffusive flow test, filter manufacturers specify a maximum allowable water intrusion value. Above this value, a hydrophobic membrane filter is classified as non-integral.

References for FILTER INTEGRITY TESTING:

  1. Cooper and Gunn’s. Tutorial Pharmacy by S.J.Carter.
  2. Pharmaceutical engineering; K. Sambamurthy
  3. Pharmaceutical engineering; principles and practices, C.V.S. Subrahmanyam
  4. Encyclopedia of pharmaceutical technology, vol 3, edited by James Swarbrick.
  5. Pikal, M.J.; Lukes, A.L.; Lang, J.E. Thermal decomposition of amorphous beta-lactam antibacterials. J. Pharm. Sci. 1977, 66, 1312–1316.
  6. Pikal, M.J.; Lukes, A.L.; Lang, J.E.; Gaines, K. Quantitative crystallinity determinations of beta-lactam antibiotics by solution calorimetry: correlations with stability. J. Pharm. Sci. 1978, 67, 767–773.

Pikal, M.J.; Dellerman, K.M. Stability testing of pharmaceuticals by high-sensitivity isothermal calorimetry at 25_C: cephalosporins in the solid and aqueous solution states. Int. J. Pharm. 1989, 50, 233–252.

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B.Pharmacy & M. Pharmacy Projects: Titles Project Work Topics {Pharmaceutics}

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B.Pharmacy & M. Pharmacy Projects: Titles Project Work Topics {Pharmaceutics}

Hello Buddies. Here are few topics and title which can be used for B.Pharmacy & M. Pharmacy Projects in the final year. Particularly these are the Titles Project Work Topics for Pharmaceutics specialization. 

PHARMACEUTICS: B.Pharmacy & M. Pharmacy Projects: Topics For Project Work Of Pharmaceutics Students

 

  1. Formulation and evaluation of topical formulations of Bosweellic acids guggulosterones for the treatment of rheumatoid arthritis
  2. Supramolecular: Nanomedicine and nanotechnology pre-concentration, separation and recovery of toxic trace metal
  3. Supercritical fluid technology
  4. Studies on design and development of dissolvable oral drug delivery systems of a poorly water soluble non-steroidal anti-inflammatory drug
  5. Designing of a polyherbal formulation for metabolic disorder
  6. Development of lipidic drug delivery system for bioavailability improvement of the poorly water soluble antihypertensive drug
  7. Formulation, development of rapidly dissolving films containing anti-histaminic drug
  8. Formulation and Evaluation of colon targeted drug delivery systems
  9. Formulation, development and evaluation of controlled drug delivery of analgesics via novel routes
  10. B.Pharmacy & M. Pharmacy Projects: Titles Project Work Topics {Pharmaceutics}

b pharm projects topics and review articles:

  1. Rotary Tableting Press
  2. Finished Goods Quality Assurance.
  3. The Perfect Excipient
  4. Product Composition Affects Material Selection
  5. Fractional Experimental Design. Study of the Incompatibility of Benzocaine in Throat Lozenges
  6. Moisture content of tablet
  7. Stability of the colorant
  8. Changes in tablet hardness. friability. dissolution rate
  9. Formulation and evaluation of colon targeted drug delivery system of mebeverine hydrochloride
  10. Any significant pharmaceutical problem with the drug product related to its formulation, drug delivery and bio-availability.
  11. Methods and types of dosage form which already exsits in the market.
  12. Points you have to study and review for literature purpose:
  13. One should have to study the history of the drug thoroughly.
  14. Early and common problems related to exsisting dosage forms.

M.pharm project topics in pharmaceutics

  1. Drug-induced diseases and Teratogenicity
  2. Drug dependences, Drug abuse, addictive drugs and their treatment, complications.
  3. Introduction to drying processes – Study of Tray Dryers: fluidized Bed Dryer.
  4. Vacuum Dryer and Freeze Dryer.
  5. Viscosity-Imparting Agents in Disperse Systems
  6. Oral Aqueous Suspensions
  7. Topical Suspensions A review
  8. Bio-availability of drugs, including factors affecting it
  9. complete data base of drug available by any source like internet, libraries etc.
  10. Complete physico0chemical parameter of pure drug.
  11. Study of complete drug profile from authenticated sources like pharmacopoeias, FDA online sites etc.
  12. study of depth of the drug and its available formulations and problems related with that available problems.
  13. Development and assessment of Novel In-situ Ocular gels of Ketorolac Tromethamine
  14. Dissolution improvement of weakly soluble drugs using hot melt Extrusion Technology.
  15. Dissolution rate Enhancement of Glimepiride and olanzapine by spray drying technique.
  16. Enhancement of dissolution rate of aceclofenac with meglumin as a novel ternary component
  17. Formulation and estimate of Aceclofenac Topical Emulgels.

B.PHARMACY & M. PHARMACY PROJECTS: TOPICS FOR PROJECT WORK OF PHARMACEUTICS STUDENTS

  • Formulation and estimation of atomoxetine HCL buccal drug delivery system
  • Formulation and assessment of capecitabine tablets for colon specific drug delivery system
  • Formulation and Evaluation of cyclobenzaprine hydrochloride loaded sustained release microspheres.
  • Formulation and evaluation of diclofenac sodium matrix tablets using new natural polymer
  • Formulation and evaluation of duloxetine HCL delayed release enteric coated capsules
  • Formulation and evaluation of fast disintergrating tablets and films for carbinoxamine maleate
  • Formulation and evaluation of frusemide semi solid matrix capsules by liquid filling technology
  • Formulation and Evaluation of Glipizide microemulsion.
  • Formulation and evaluation of implantable drug delivery system for temozolamide
  • Formulation and evaluation of ornidazole topical emulgels
  • Formulation and Evaluation pantoprazole sodium enteric coated tablets using different super disintegrants.
  • Screening, optimization and characterization of polymers for orally dissolving films.

 

PHARMACEUTICS Project Topics: B.Pharmacy

 

Formulation, Evaluation And Validation Of Orally Disintegrating Rizatriptan Benzoate Tablet.

Sustained Release Effervescent Floating Bilayer Tablets A Review Of Novel Approach.

Nanocapsules: Nano Novel Drug Delivery System.

Formulation And Evaluation Of Atomoxetine Hydrochloride Sustained Release Tablets.

Nano-Particles Containing Anticancer Drug.

Solubility Enhancement Of Poorly Water Soluble Drug By Spherical Crystallization Technique.

In-Vitro Antiproliferative Activity Of M. Azedarach.

Impact And Management Tool For Identification And Reduction Of Human Errors In Pharmaceuticals Industry.

Solid Dispersion- A Review.

Validation-In Pharmaceutical Industry : Cleaning Validation – A Brief.

A Review On Gastro-Intestinal Drug Esomeprazole.

Effect Of Ascorbic Acid On Dissolution Stability Of Rifampicin In Market Fixed Dose Combination Products For Tuberculosis.

Prepration And Evaluation Of Nano-Emulsion Formulation By Using Spontaneous Emulsification.

Preparation Method, Properties And Crosslinking Of Hydrogel: A Review.

Formulation Development And In Vitro Evaluation Of Mouth Dissolving Tablets Of Pioglitazone Hydrochloride.

Formulation And Evaluation Of Orodispersible Tablets To Enhance Dissolution Rate Of Lamotrigine By Using Solid Dispersion Technique.

Formulation And Evaluation Of Metformin Hydrochloride Buccal Patch

Recent Pharmaceutics project topics – Current research topics

  1. Lipid Based Solid Self-Emulsifying Delivery System Of Pitavastatin Calcium: Development And Characterization
  2. Design And Characterization Of Paclitaxel Loaded Nanoparticles With Piperine
  3. Development And Characterization Of Topical Microemulsion Of Tranexamic Acid
  4. Exploring Career Advancement Of Pharmacy Support Staff Within Two Queensland Hospitals: A Qualitative Study
  5. Significant Predictors For Topiramate Pharmacokinetics: A Systematic Review Of Population Pharmacokinetic Studies
  6. Nanocapsule Formation By Interfacial Polymer Deposition Following Solvent Displacement
  7. Stability Indicating Reverse Phase High Performance Liquid Chromatography Method For Simultaneous Estimation Of Allantoin, Hydroquinone And Tretenoin In Cream Formulation.
  8. Process Control And End-Point Determination Of A Fluid Bed Granulation By Application Of Near Infra-Red Spectroscopy
  9. Chirality And Its Importance In Pharmaceutical Field-An Overview
  10. Recent Advances In Nanosponges As Drug Delivery System
  11. Fabrication Of Mebendazole Loaded Solid Lipid Nanoparticles: Formulation, Optimization, Characterization, Stabilization, And In-Vitro Evaluation
  12. In Vitro Evaluation And Characterization Of The Nanoparticulate System Of Novel Taxane Derivative
  13. A Comprehensive Review On Solid Lipid Nanoparticles As Delivery Vehicle For Enhanced Pharmacokinetic And Pharmacodynamic Activity Of Poorly Soluble Drugs

The above topics are from the recent work of the scientists and researchers. You can get an idea of the current trend in the Pharmaceutics department. Try to get more information on these type of research work from scholars or research papers and try to do your own way of the topics so that you can get amazing project for your M Pharmacy or B Pharmacy Project topics.

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This article is updated now. M.pharm pharmaceutics project new list 2022