LABELING -Pharmaceutical Labeling Requirements Theory PPT PDF

LABELING -Pharmaceutical Labeling Requirements Theory PPT PDF

Labeling:

The term “labeling” designates all labels and other written, printed, or graphic matter upon an immediate container of an article or upon, or in, any package or wrapper in which it is enclosed, except any outer shipping container.

Labeling?

The term “label” designates that part of the labeling upon the immediate container. A shipping container containing a single article, unless such container is also essentially the immediate container or the outside of the consumer package, is labeled with a minimum of product identification (except for controlled articles), lot number, expiration date, and conditions for storage and distribution. Articles in these compendia are subject to compliance with such labeling requirements as may be promulgated by governmental bodies in addition to the compendial requirements set forth for the articles.

Label: Amount of Ingredient Per Dosage Unit:

The strength of a drug product is expressed on the container label in terms of micrograms or milligrams or grams or percentage of the therapeutically active moiety or drug substance, whichever form is used in the title, unless otherwise indicated in an individual monograph. Both the active moiety and drug substance names and their equivalent amounts are then provided in the labeling. Official articles in capsule, tablet, or other unit dosage form shall be labeled to express the quantity of each active ingredient or recognized nutrient contained in each such unit; except that, in the case of unit-dose oral solutions or suspensions, whether supplied as liquid preparations or as liquid preparations that are constituted from solids upon addition of a designated volume of a specific diluent, the label shall express the quantity of each active ingredient or recognized nutrient delivered under the conditions prescribed in Deliverable Volume 〈698〉. Official drug products not in unit dosage form shall be labeled to express the quantity of each active ingredient in each milliliter or in each gram, or to express the percentage of each such ingredient (see 8.140., Percentage Concentrations), except that oral liquids or solids intended to be constituted to yield oral liquids may, alternatively, be labeled in terms of each 5-mL portion of the liquid or resulting liquid. Unless otherwise indicated in a monograph or chapter, such declarations of strength or quantity shall be stated only in metric units. 

Labeling: Use of Leading and Terminal Zeros

To help minimize the possibility of errors in the dispensing and administration of drugs, the quantity of active ingredient when expressed in whole numbers shall be shown without a decimal point that is followed by a terminal zero (e.g., express as 4 mg [not 4.0 mg]). The quantity of active ingredient when expressed as a decimal number smaller than 1 shall be shown with a zero preceding the decimal point (e.g., express as 0.2 mg [not .2 mg]).

Labeling of Salts of Drugs

It is an established principle that official articles shall have only one official title. For purposes of saving space on labels, and because chemical symbols for the most common inorganic salts of drugs are well known to practitioners as synonymous with the written forms, the following alternatives are permitted in labeling official articles that are salts: HCl for hydrochloride; HBr for hydrobromide; Na for sodium; and K for potassium. The symbols Na and K are intended for use in abbreviating names of the salts of organic acids, but these symbols are not used where the word Sodium or Potassium appears at the beginning of an official title (e.g., Phenobarbital Na is acceptable, but Na Salicylate is not to be written).

Labeling Vitamin-Containing Products

LABELING -Pharmaceutical Labeling Requirements Theory PPT PDF
The vitamin content of an official drug product shall be stated on the label in metric units per dosage unit. The amounts of vitamins A, D, and E may be stated also in USP Units. Quantities of vitamin A declared in metric units refer to the equivalent amounts of retinol (vitamin A alcohol). The label of a nutritional supplement shall bear an identifying lot number, control number, or batch number. 10.40.50. Labeling Botanical-Containing Products The label of an herb or other botanical intended for use as a dietary supplement bears the statement, “If you are pregnant or nursing a baby, seek the advice of a health professional before using this

Labeling Parenteral and Topical Preparations

The label of a preparation intended for parenteral or topical use states the names of all added substances (see 5.20., Added Substances, Excipients, and Ingredients and see Labeling under Injections 〈1〉), and, in the case of parenteral preparations, also their amounts or proportions, except that for substances added for adjustment of pH or to achieve isotonicity, the label may indicate only their presence and the reason for their addition.

Labeling Electrolytes:

The concentration and dosage of electrolytes for replacement therapy (e.g., sodium chloride or potassium chloride) shall be stated on the label in milliequivalents (mEq). The label of the product shall indicate also the quantity of ingredient(s) in terms of weight or percentage concentration.

Labeling Alcohol:

The content of alcohol in a liquid preparation shall be stated on the label as a percentage (v/v) of C2H5OH.

Symbols Commonly Employed for SI Metric Unit

Symbols commonly employed for SI metric units and other units
are as follows:
Bq = becquerel dL = deciliter
kBq = kilobecquerel L = liter
MBq = megabecquerel mL = milliliterc
GBq = gigabecquerel μL = microliter
Ci = curie Eq = gram-equivalent weight
mCi = millicurie mEq = milliequivalent
μCi = microcurie mol = gram-molecular weight (mole)
nCi = nanocurie Da = dalton (relative molecular mass)
Gy = gray mmol = millimole
mGy = milligray Osmol = osmole
m = meter mOsmol = milliosmole
dm = decimeter Hz = hertz
cm = centimeter kHz = kilohertz
mm = millimeter MHz = megahertz
μm = micrometer (0.001mm) V = volts
nm = nanometera MeV = million electron volts
kg = kilogram keV = kilo-electron volt
g = gram mV = millivolt
mg = milligram psi = pounds per square inch
μg; mcg = microgramb Pa = pascal
ng = nanogram kPa = kilopascal
pg = pictogram g = gravity (in centrifugation)
fg = femtogram
a Previously the symbol mμ (for millimicron) was used.
b One milliliter (mL) is used herein as the equivalent of one cubic centimeter (cc).
c The symbol μg is used in the USP and NF to represent micrograms, but micrograms
may be represented as “mcg” for labeling and prescribing purposes. The term
“gamma,” symbolized by γ, frequently is used to represent micrograms in biochemical
literature

[#PDF PPT] Hot Air Oven Working Principle Sterilization Diagram SOP Uses Temperature

hot air oven working pdf

Hot Air Oven Working Principle Sterilization Labelled Diagram Temperature [ #PDF PPT ] is the main theme of this article. Sterilization and aseptic processing are essential practices for healthcare product manufacture and many healthcare services. The execution of these processes in an appropriate manner is essential for patient safety.

A hot air oven is used to sterilize equipment and materials used in the medical field. A hot air oven is a type of dry heat sterilization. Dry heat sterilization is used on equipment that cannot be wet, and on material that will not melt, catch fire, or change form when exposed to high temperatures. Moist heat sterilization uses water to boil items or steam them to sterilize and does not take as long as dry heat sterilization. Examples of items that are not sterilized in a hot air oven are surgical dressings, rubber items, or plastic material. Items that are sterilized in a hot air oven include:

Glassware (petri dishes, flasks, pipettes, and test tubes)
Powders (starch, zinc oxide, and sulfadiazine)
Materials that contain oils
Metal equipment (scalpels, scissors, and blades)
Glass test tubes can be sterilized using a hot air oven
Glass test tubes can be sterilized using a hot air oven
Hot air ovens use extremely high temperatures over several hours to destroy microorganisms and bacterial spores. The ovens use conduction to sterilize items by heating the outside surfaces of the item, which then absorbs the heat and moves it towards the center of the item.

The commonly-used temperatures and time that hot air ovens need to sterilize materials is 170 degrees Celsius for 30 minutes, 160 degrees Celsius for 60 minutes, and 150 degrees Celsius for 150 minutes.

hot air oven images

Principle of HOT AIR OVEN (Dry heat sterilization) 

Sterilizing by dry heat is accomplished by conduction. The heat is absorbed by the outside surface of the item, then passes towards the centre of the item, layer by layer. The entire item will eventually reach the temperature required for sterilization to take place.

Dry heat does most of the damage by oxidizing molecules. The essential cell constituents are destroyed and the organism dies. The temperature is maintained for almost an hour to kill the most difficult of the resistant spores.

The most common time-temperature relationships for sterilization with hot air sterilizers are

170°C (340°F) for 30 minutes,
160°C (320°F) for 60 minutes, and
150°C (300°F) for 150 minutes or longer depending up the volume.

Hot Air Oven ppt working principle uses diagam ppt

Hot Air Oven Working Principle Sterilization Labelled Diagram PDF ppt

Note: Bacillus atrophaeus spores should be used to monitor the sterilization process for dry heat because they are more resistant to dry heat than the spores of Geobacillus stearothermophilus. The primary lethal process is considered to be oxidation of cell constituents.

working principle of hot air oven

Types of HOT AIR OVEN

the static-air type and
the forced-air type.

There are two types of dry-heat sterilizers:

the static-air type and
the forced-air type.
The static-air type is referred to as the oven-type sterilizer as heating coils in the bottom of the unit cause the hot air to rise inside the chamber via gravity convection. This type of dry-heat sterilizer is much slower in heating, requires longer time to reach sterilizing temperature, and is less uniform in temperature control throughout the chamber than is the forced-air type.

The forced-air or mechanical convection sterilizer is equipped with a motor-driven blower that circulates heated air throughout the chamber at a high velocity, permitting a more rapid transfer of energy from the air to the instruments.

Hot Air Oven Labelled Diagram

hot air oven labelled diagram

Uses of HOT AIR OVEN (dry heat sterilization)

A dry heat cabinet is easy to install and has relatively low operating costs;
It penetrates materials
It is nontoxic and does not harm the environment;
And it is noncorrosive for metal and sharp instruments.
Disadvantages for dry heat sterilization

Time consuming method because of slow rate of heat penetration and microbial killing.
High temperatures are not suitable for most materials.

Working Principle of HOT AIR OVEN

Sterilizing by dry heat is accomplished by conduction. The heat is absorbed by the outside surface of the item, then passes towards the centre of the item, layer by layer. The entire item will eventually reach the temperature required for sterilization to take place.

Dry heat does most of the damage by oxidizing molecules. The essential cell constituents are destroyed and the organism dies. The temperature is maintained for almost an hour to kill the most difficult of the resistant spores.

The most common time-temperature relationships for sterilization with hot air sterilizers are

170°C (340°F) for 30 minutes,
160°C (320°F) for 60 minutes, and
150°C (300°F) for 150 minutes or longer depending up the volume.

Different Types of Hot Air Ovens
There are two types of hot air ovens. One is a forced air hot air oven and the other is a static air hot air oven. The forced air hot air oven is more effective than the static air hot air oven.

The forced air hot air oven works by heating the oven and using a fan to move the hot air around. This helps prevent the hot air from rising to the top of the oven and keeping the cooler air at the bottom. The fan keeps the hot air moving around at a consistent temperature throughout the oven.

The static air hot air oven works by using a heating coil at the bottom of the oven. The heat rises throughout the oven and takes a longer time to reach the desired temperature. Since the heat is not circulated as with a forced air hot air oven the temperature is not consistent throughout the oven.

STANDARD OPERATING PROCEDURE of HOT AIR OVEN

Aim:

To lay down the procedure for operation of Hot Air Oven.

Procedure:

1. Connect the power supply.
2. Switch “ON” the main power supply and instrument mains.
Temperature setting
3. Press SET POINT (x/w) key to set the required temperature. press ↑ to
increase the temperature and ↓ to reduce the temperature
4. The temp. Sensor will maintain the set temp which is indicated by the blinking
of set temp on the display screen.
5. The duration of time can also be adjusted using the time adjustment knob
6. After use,SWITCH OFF the power supply.

Safety & Precautions:

=> Maximum Temp. : 350o
C.
=> Ensure that the Exhaust blower is ON before starting the oven.
=> Ensure the GN2 plant is UP.
=> Ensure that temperature does not shoot higher than the set temperature

Cleaning:

# Wipe the surface, walls, top, bottom and trays of the oven with dry lint free
cloth on daily basis so that there will be no dust particles in the oven.
# Wipe all the parts and outer surface of the Oven with wet lint free cloth
soaked in purified water, on weekly basis and fill the weekly cleaning

Note: Bacillus atrophaeus spores should be used to monitor the sterilization process for dry heat because they are more resistant to dry heat than the spores of Geobacillus stearothermophilus. The primary lethal process is considered to be oxidation of cell constituents.

Hot Air Oven Uses ( Advantages) :

Items that are sterilized in a hot air oven include:

Glassware (petri dishes, flasks, pipettes, and test tubes)
Powders (starch, zinc oxide, and sulfadiazine)
Materials that contain oils
Metal equipment (scalpels, scissors, and blades)
Glass test tubes can be sterilized using a hot air oven
Glass test tubes can be sterilized using a hot air oven
Hot air ovens use extremely high temperatures over several hours to destroy microorganisms and bacterial spores. The ovens use conduction to sterilize items by heating the outside surfaces of the item, which then absorbs the heat and moves it towards the center of the item.

Note:Items that are not sterilized in a hot air oven are surgical dressings, rubber items, or plastic material.

Disadvantages for dry heat sterilization

Time consuming method because of slow rate of heat penetration and microbial killing.
High temperatures are not suitable for most materials.

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[PPT PDF] Pharmaceutical Water System Validation – IDENTIFICATION OF MICROORGANISMS

[PPT PDF] Pharmaceutical Water System Validation - IDENTIFICATION OF MICROORGANISMS

IDENTIFICATION OF MICROORGANISMS – Pharmaceutical Water System Validation

Identifying the isolates recovered from water monitoring methods may be important in instances where specific waterborne microorganisms may be detrimental to the products or processes in which the water is used. Microorganism information such as this may also be useful when identifying the source of microbial contamination in a product or process. Often a limited group of microorganisms is routinely recovered from a water system. After repeated recovery and characterization, an experienced microbiologist may become proficient at their identification based on only a few recognizable traits such as colonial morphology and staining characteristics. This may allow for a reduction in the number of identifications to representative colony types, or, with proper analyst qualification, may even allow testing short cuts to be taken for these microbial identifications.

ALERT AND ACTION LEVELS AND SPECIFICATIONS

Though the use of alert and action levels is most often associated with microbial data, they can be associated with any attribute. In pharmaceutical water systems, almost every quality attribute, other than microbial quality, can be very rapidly determined with near-real time results. These short-delay data can give immediate system performance feedback, serving as ongoing process control indicators. However, because some attributes may not continuously be monitored or have a long delay in data availability (like microbial monitoring data), properly established Alert and Action Levels can serve as an early warning or indication of a potentially approaching quality shift occurring between or at the next periodic monitoring. In a validated water system, process controls should yield relatively constant and more than adequate values for these monitored attributes such that their Alert and Action Levels are infrequently broached.

As process control indicators, alert and action levels are designed to allow remedial action to occur that will prevent a system from deviating completely out of control and producing water unfit for its intended use. This “intended use” minimum quality is sometimes referred to as a “specification” or “limit”. In the opening paragraphs of this chapter, rationale was presented for no microbial specifications being included within the body of the bulk water (Purified Water and Water for Injection) monographs. This does not mean that the user should not have microbial specifications for these waters. To the contrary, in most situations such specifications should be established by the user. The microbial specification should reflect the maximum microbial level at which the water is still fit for use without compromising the quality needs of the process or product where the water is used. Because water from a given system may have many uses, the most stringent of these uses should be used to establish this specification.

Where appropriate, a microbial specification could be qualitative as well as quantitative. In other words, the number of total microorganisms may be as important as the number of a specific microorganism or even the absence of a specific microorganism. Microorganisms that are known to be problematic could include opportunistic or overt pathogens, nonpathogenic indicators of potentially undetected pathogens, or microorganisms known to compromise a process or product, such as by being resistant to a preservative or able to proliferate in or degrade a product. These microorganisms comprise an often ill-defined group referred to as “objectionable microorganisms”. Because objectionable is a term relative to the water’s use, the list of microorganisms in such a group should be tailored to those species with the potential to be present and problematic. Their negative impact is most often demonstrated when they are present in high numbers, but depending on the species, an allowable level may exist, below which they may not be considered objectionable.

[PPT PDF] Pharmaceutical Water System Validation – IDENTIFICATION OF MICROORGANISMS IDENTIFICATION OF MICROORGANISMS – Pharmaceutical warer system ppt [PPT PDF] Pharmaceutical Water System Validation - IDENTIFICATION OF MICROORGANISMS

As stated above, alert and action levels for a given process control attribute are used to help maintain system control and avoid exceeding the pass/fail specification for that attribute. Alert and action levels may be both quantitative and qualitative. They may involve levels of total microbial counts or recoveries of specific microorganisms. Alert levels are events or levels that, when they occur or are exceeded, indicate that a process may have drifted from its normal operating condition. Alert level excursions constitute a warning and do not necessarily require a corrective action. However, alert level excursions usually lead to the alerting of personnel involved in water system operation as well as QA. Alert level excursions may also lead to additional monitoring with more intense scrutiny of resulting and neighboring data as well as other process indicators. Action levels are events or higher levels that, when they occur or are exceeded, indicate that a process is probably drifting from its normal operating range. Examples of kinds of action level “events” include exceeding alert levels repeatedly; or in multiple simultaneous locations, a single occurrence of exceeding a higher microbial level; or the individual or repeated recovery of specific objectionable microorganisms. Exceeding an action level should lead to immediate notification of both QA and personnel involved in water system operations so that corrective actions can immediately be taken to bring the process back into its normal operating range. Such remedial actions should also include efforts to understand and eliminate or at least reduce the incidence of a future occurrence. A root cause investigation may be necessary to devise an effective preventative action strategy. Depending on the nature of the action level excursion, it may also be necessary to evaluate its impact on the water uses during that time. Impact evaluations may include delineation of affected batches and additional or more extensive product testing. It may also involve experimental product challenges.

Alert and action levels should be derived from an evaluation of historic monitoring data called a trend analysis. Other guidelines on approaches that may be used, ranging from “inspectional”to statistical evaluation of the historical data have been published. The ultimate goal is to understand the normal variability of the data during what is considered a typical operational period. Then, trigger points or levels can be established that will signal when future data may be approaching (alert level) or exceeding (action level) the boundaries of that “normal variability”. Such alert and action levels are based on the control capability of the system as it was being maintained and controlled during that historic period of typical control.

In new water systems where there is very limited or no historic data from which to derive data trends, it is common to simply establish initial alert and action levels based on a combination of equipment design capabilities but below the process and product specifications where water is used. It is also common, especially for ambient water systems, to microbiologically “mature” over the first year of use. By the end of this period, a relatively steady state microbial population (microorganism types and levels) will have been allowed or promoted to develop as a result of the collective effects of routine system maintenance and operation, including the frequency of unit operation rebeddings, backwashings, regenerations, and sanitizations. This microbial population will typically be higher than was seen when the water system was new, so it should be expected that the data trends (and the resulting alert and action levels) will increase over this “maturation” period and eventually level off.

Pharmaceutical water System

A water system should be designed so that performance-based alert and action levels are well below water specifications. With poorly designed or maintained water systems, the system owner may find that initial new system microbial levels were acceptable for the water uses and specifications, but the mature levels are not. This is a serious situation, which if not correctable with more frequent system maintenance and sanitization, may require expensive water system renovation or even replacement. Therefore, it cannot be overemphasized that water systems should be designed for ease of microbial control, so that when monitored against alert and action levels, and maintained accordingly, the water continuously meets all applicable specifications.

An action level should not be established at a level equivalent to the specification. This leaves no room for remedial system maintenance that could avoid a specification excursion. Exceeding a specification is a far more serious event than an action level excursion. A specification excursion may trigger an extensive finished product impact investigation, substantial remedial actions within the water system that may include a complete shutdown, and possibly even product rejection.

Another scenario to be avoided is the establishment of an arbitrarily high and usually nonperformance based action level. Such unrealistic action levels deprive users of meaningful indicator values that could trigger remedial system maintenance. Unrealistically high action levels allow systems to grow well out of control before action is taken, when their intent should be to catch a system imbalance before it goes wildly out of control.

Because alert and action levels should be based on actual system performance, and the system performance data are generated by a given test method, it follows that those alert and action levels should be valid only for test results generated by the same test method. It is invalid to apply alert and action level criteria to test results generated by a different test method. The two test methods may not equivalently recover microorganisms from the same water samples. Similarly invalid is the use of trend data to derive alert and action levels for one water system, but applying those alert and action levels to a different water system. Alert and action levels are water system and test method specific.

Nevertheless, there are certain maximum microbial levels above which action levels should never be established. Water systems with these levels should unarguably be considered out of control. Using the microbial enumeration methodologies suggested above, generally considered maximum action levels are 100 cfu per mL for Purified Water and 10 cfu per 100 mL for Water for Injection. However, if a given water system controls microorganisms much more tightly than these levels, appropriate alert and action levels should be established from these tighter control levels so that they can truly indicate when water systems may be starting to trend out of control. These in-process microbial control parameters should be established well below the user-defined microbial specifications that delineate the water’s fitness for use.

Special consideration is needed for establishing maximum microbial action levels for Drinking Water because the water is often delivered to the facility in a condition over which the user has little control. High microbial levels in Drinking Water may be indicative of a municipal water system upset, broken water main, or inadequate disinfection, and therefore, potential contamination with objectionable microorganisms. Using the suggested microbial enumeration methodology, a reasonable maximum action level for Drinking Water is 500 cfu per mL. Considering the potential concern for objectionable microorganisms raised by such high microbial levels in the feedwater, informing the municipality of the problem so they may begin corrective actions should be an immediate first step. In-house remedial actions may or may not also be needed, but could include performing additional coliform testing on the incoming water and pretreating the water with either additional chlorination or UV light irradiation or filtration or a combination of approaches.

Source : USP

Expert Committee : (PW05) Pharmaceutical Waters 05

USP29–NF24 Page 3056

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

Pharmaceutical Water System Ppt,

Pharmaceutical Water Systems,

Purified Water Specification As Per Usp,

Pharmaceutical Water System Design Operation And Validation Pdf,

pharmaceutical water system design operation and validation,

pharmaceutical water system ppt – What is Pharmaceutical water,

purified water & Water for Injection SOP as per usp,

Pharmaceutical Water Systems: Storage & Distribution Systems,

pharmaceutical water system : Inspection of Pharmaceutical water systems,

pharmaceutical water Production : Water purification systems,

Pharmaceutical Water Systems: Types: Water quality specifications,

Pharmaceutical Water System: principles for pharmaceutical water systems

[PPT PDF] Pharmaceutical Water System Design Validation -SAMPLING CONSIDERATIONS

[PPT PDF] Pharmaceutical Water System Design Validation -SAMPLING CONSIDERATIONS

Pharmaceutical Water System- SAMPLING CONSIDERATIONS

Water systems should be monitored at a frequency that is sufficient to ensure that the system is in control and continues to produce water of acceptable quality. Samples should be taken from representative locations within the processing and distribution system. Established sampling frequencies should be based on system validation data and should cover critical areas including unit operation sites. The sampling plan should take into consideration the desired attributes of the water being sampled. For example, systems for Water for Injection because of their more critical microbiological requirements, may require a more rigorous sampling frequency.

Analyses of water samples often serve two purposes: in-process control assessments and final quality control assessments. In-process control analyses are usually focused on the attributes of the water within the system. Quality control is primarily concerned with the attributes of the water delivered by the system to its various uses. The latter usually employs some sort of transfer device, often a flexible hose, to bridge the gap between the distribution system use-point valve and the actual location of water use. The issue of sample collection location and sampling procedure is often hotly debated because of the typically mixed use of the data generated from the samples, for both in-process control and quality control. In these single sample and mixed data use situations, the worst-case scenario should be utilized. In other words, samples should be collected from use points using the same delivery devices, such as hoses, and procedures, such as preliminary hose or outlet flushing, as are employed by production from those use points. Where use points per se cannot be sampled, such as hard-piped connections to equipment, special sampling ports may be used. In all cases, the sample must represent as closely as possible the quality of the water used in production. If a point of use filter is employed, sampling of the water prior to and after the filter is needed because the filter will mask the microbial control achieved by the normal operating procedures of the system.

Samples containing chemical sanitizing agents require neutralization prior to microbiological analysis. Samples for microbiological analysis should be tested immediately, or suitably refrigerated to preserve the original microbial attributes until analysis can begin. Samples of flowing water are only indicative of the concentration of planktonic (free floating) microorganisms present in the system. Biofilm microorganisms (those attached to water system surfaces) are usually present in greater numbers and are the source of the planktonic population recovered from grab samples. Microorganisms in biofilms represent a continuous source of contamination and are difficult to directly sample and quantify. Consequently, the planktonic population is usually used as an indicator of system contamination levels and is the basis for system Alert and Action Levels. The consistent appearance of elevated planktonic levels is usually an indication of advanced biofilm development in need of remedial control. System control and sanitization are key in controlling biofilm formation and the consequent planktonic population.

Sampling for chemical analyses is also done for in-process control and for quality control purposes. However, unlike microbial analyses, chemical analyses can be and often are performed using on-line instrumentation. Such on-line testing has unequivocal in-process control purposes because it is not performed on the water delivered from the system. However, unlike microbial attributes, chemical attributes are usually not significantly degraded by hoses. Therefore, through verification testing, it may be possible to show that the chemical attributes detected by the on-line instrumentation (in-process testing) are equivalent to those detected at the ends of the use point hoses (quality control testing). This again creates a single sample and mixed data use scenario. It is far better to operate the instrumentation in a continuous mode, generating large volumes of in-process data, but only using a defined small sampling of that data for QC purposes. Examples of acceptable approaches include using highest values for a given period, highest time-weighted average for a given period (from fixed or rolling sub-periods), or values at a fixed daily time. Each approach has advantages and disadvantages relative to calculation complexity and reflection of continuous quality, so the user must decide which approach is most suitable or justifiable.

Pharmaceutical Water System-CHEMICAL CONSIDERATIONS

The chemical attributes of Purified Water and Water for Injection were specified by a series of chemistry tests for various specific and nonspecific attributes with the intent of detecting chemical species indicative of incomplete or inadequate purification. While these methods could have been considered barely adequate to control the quality of these waters, they nevertheless stood the test of time. This was partly because the operation of water systems was, and still is, based on on-line conductivity measurements and specifications generally thought to preclude the failure of these archaic chemistry attribute tests.

USP moved away from these chemical attribute tests to contemporary analytical technologies for the bulk waters Purified Water and Water for Injection. The intent was to upgrade the analytical technologies without tightening the quality requirements. The two contemporary analytical technologies employed were TOC and conductivity. The TOC test replaced the test for Oxidizable substances that primarily targeted organic contaminants. A multistaged Conductivity test which detects ionic (mostly inorganic) contaminants replaced, with the exception of the test for Heavy metals, all of the inorganic chemical tests (i.e., Ammonia, Calcium, Carbon dioxide, Chloride, Sulfate).

Pharmaceutical Water Systems: Pharmaceutical Water Storage & Distribution Systems

Replacing the heavy metals attribute was considered unnecessary because (a) the source water specifications (found in the NPDWR) for individual Heavy metals were tighter than the approximate limit of detection of the Heavy metals test for USP XXII Water for Injection and Purified Water (approximately 0.1 ppm), (b) contemporary water system construction materials do not leach heavy metal contaminants, and (c) test results for this attribute have uniformly been negative—there has not been a confirmed occurrence of a singular test failure (failure of only the Heavy metals test with all other attributes passing) since the current heavy metal drinking water standards have been in place. Nevertheless, since the presence of heavy metals in Purified Water or Water for Injection could have dire consequences, its absence should at least be documented during new water system commissioning and validation or through prior test results records.

Total solids and pH are the only tests not covered by conductivity testing. The test for Total solids was considered redundant because the nonselective tests of conductivity and TOC could detect most chemical species other than silica, which could remain undetected in its colloidal form. Colloidal silica in Purified Water and Water for Injection is easily removed by most water pretreatment steps and even if present in the water, constitutes no medical or functional hazard except under extreme and rare situations. In such extreme situations, other attribute extremes are also likely to be detected. It is, however, the user’s responsibility to ensure fitness for use. If silica is a significant component in the source water, and the purification unit operations could be operated or fail and selectively allow silica to be released into the finished water (in the absence of co-contaminants detectable by conductivity), then either silica-specific or a total solids type testing should be utilized to monitor and control this rare problem.

The pH attribute was eventually recognized to be redundant to the conductivity test (which included pH as an aspect of the test and specification); therefore, pH was dropped as a separate attribute test.

The rationale used by USP to establish its conductivity specification took into consideration the conductivity contributed by the two least conductive former attributes of Chloride and Ammonia, thereby precluding their failure had those wet chemistry tests been performed. In essence, the Stage 3 conductivity specifications (see Water Conductivity  645 ) were established from the sum of the conductivities of the limit concentrations of chloride ions (from pH 5.0 to 6.2) and ammonia ions (from pH 6.3 to 7.0), plus the unavoidable contribution of other conductivity-contributing ions from water (H+ and OH–), dissolved atmospheric CO2 (as HCO3–), and an electro-balancing quantity of either Na+ of Cl–, depending on the pH-induced ionic imbalance (see Table 1). The Stage 2 conductivity specification is the lowest value on this table, 2.1 µS/cm. The Stage 1 specifications, designed primarily for on-line measurements, were derived essentially by summing the lowest values in the contributing ion columns for each of a series of tables similar to Table 1, created for each 5  increment between 0  and 100 . For example purposes, the italicized values in Table 1, the conductivity data table for 25 , were summed to yield a conservative value of 1.3 µS/cm, the Stage 1 specification for a nontemperature compensated, nonatmosphere equilibrated water sample that actual had a measured temperature of 25  to 29 . Each 5  increment table was similarly treated to yield the individual values listed in the table of Stage 1 specifications (see Water Conductivity  645 ).

As stated above, this rather radical change to utilizing a conductivity attribute as well as the inclusion of a TOC attribute allowed for on-line measurements. This was a major philosophical change and allowed major savings to be realized by industry. The TOC and conductivity tests can also be performed “off-line” in the laboratories using collected samples, though sample collection tends to introduce opportunities for adventitious contamination that can cause false high readings. The collection of on-line data is not, however, without challenges. The continuous readings tend to create voluminous amounts of data where before only a single data point was available. As stated under Sampling Considerations, continuous in-process data is excellent for understanding how a water system performs during all of its various usage and maintenance events in real time, but is too much data for QC purposes. Therefore, a justifiable fraction or averaging of the data can be used that is still representative of the overall water quality being used.

Packaged waters present a particular dilemma relative to the attributes of conductivity and TOC. The package itself is the source of chemicals (inorganics and organics) that leach over time into the water and can easily be detected. The irony of organic leaching from plastic packaging is that when the Oxidizable substances test was the only “organic contaminant” test for both bulk and packaged waters, that test’s insensitivity to those organic leachables rendered their presence in packaged water at high concentrations (many times the TOC specification for bulk water) virtually undetectable. Similarly, glass containers can also leach inorganics, such as sodium, which are easily detected by conductivity, but are undetected by the wet chemistry tests for water (other than pH or Total solids). Most of these leachables are considered harmless by current perceptions and standards at the rather significant concentrations present. Nevertheless, they effectively degrade the quality of the high-purity waters placed into these packaging system. Some packaging materials contain more leachables than others and may not be as suitable for holding water and maintaining its purity.

The attributes of conductivity and TOC tend to reveal more about the packaging leachables than they do about the water’s original purity. These “allowed” leachables could render the packaged versions of originally equivalent bulk water essentially unsuitable for many uses where the bulk waters are perfectly adequate.

[PPT PDF] Pharmaceutical Water System Design Validation -SAMPLING CONSIDERATIONS pdf [PPT PDF] Pharmaceutical Water System Design Validation -SAMPLING CONSIDERATIONS

Pharmaceutical Water System-MICROBIAL CONSIDERATIONS

The major exogenous source of microbial contamination of bulk pharmaceutical water is source or feed water. Feed water quality must, at a minimum, meet the quality attributes of Drinking Water for which the level of coliforms are regulated. A wide variety of other microorganisms, chiefly Gram-negative bacteria, may be present in the incoming water. These microorganisms may compromise subsequent purification steps. Examples of other potential exogenous sources of microbial contamination include unprotected vents, faulty air filters, ruptured rupture disks, backflow from contaminated outlets, unsanitized distribution system “openings” including routine component replacements, inspections, repairs, and expansions, inadequate drain and air-breaks, and replacement activated carbon, deionizer resins, and regenerant chemicals. In these situations, the exogenous contaminants may not be normal aquatic bacteria but rather microorganisms of soil or even human origin. The detection of nonaquatic microorganisms may be an indication of a system component failure, which should trigger investigations that will remediate their source. Sufficient care should be given to system design and maintenance in order to minimize microbial contamination from these exogenous sources.

Unit operations can be a major source of endogenous microbial contamination. Microorganisms present in feed water may adsorb to carbon bed, deionizer resins, filter membranes, and other unit operation surfaces and initiate the formation of a biofilm. In a high-purity water system, biofilm is an adaptive response by certain microorganisms to survive in this low nutrient environment. Downstream colonization can occur when microorganisms are shed from existing biofilm-colonized surfaces and carried to other areas of the water system. Microorganisms may also attach to suspended particles such as carbon bed fines or fractured resin particles. When the microorganisms become planktonic, they serve as a source of contamination to subsequent purification equipment (compromising its functionality) and to distribution systems.

Another source of endogenous microbial contamination is the distribution system itself. Microorganisms can colonize pipe surfaces, rough welds, badly aligned flanges, valves, and unidentified dead legs, where they proliferate, forming a biofilm. The smoothness and composition of the surface may affect the rate of initial microbial adsorption, but once adsorbed, biofilm development, unless otherwise inhibited by sanitizing conditions, will occur regardless of the surface. Once formed, the biofilm becomes a continuous source of microbial contamination.

[PPT PDF] Pharmaceutical Water System Design Validation -SAMPLING CONSIDERATIONS

ENDOTOXIN CONSIDERATIONS

Endotoxins are lipopolysaccharides found in and shed from the cell envelope that is external to the cell wall of Gram-negative bacteria. Gram-negative bacteria that form biofilms can become a source of endotoxins in pharmaceutical waters. Endotoxins may occur as clusters of lipopolysaccharide molecules associated with living microorganisms, fragments of dead microorganisms or the polysaccharide slime surrounding biofilm bacteria, or as free molecules. The free form of endotoxins may be released from cell surfaces of the bacteria that colonize the water system, or from the feed water that may enter the water system. Because of the multiplicity of endotoxin sources in a water system, endotoxin quantitation in a water system is not a good indicator of the level of biofilm abundance within a water system.

Pharmaceutical Water System Design Validation – Microbial Testing of Water

Endotoxin levels may be minimized by controlling the introduction of free endotoxins and microorganisms in the feed water and minimizing microbial proliferation in the system. This may be accomplished through the normal exclusion or removal action afforded by various unit operations within the treatment system as well as through system sanitization. Other control methods include the use of ultrafilters or charge-modified filters, either in-line or at the point of use. The presence of endotoxins may be monitored as described in the general test chapter Bacterial Endotoxins Test  85 .

MICROBIAL ENUMERATION CONSIDERATIONS

The objective of a water system microbiological monitoring program is to provide sufficient information to control and assess the microbiological quality of the water produced. Product quality requirements should dictate water quality specifications. An appropriate level of control may be maintained by using data trending techniques and, if necessary, limiting specific contraindicated microorganisms. Consequently, it may not be necessary to detect all of the microorganisms species present in a given sample. The monitoring program and methodology should indicate adverse trends and detect microorganisms that are potentially harmful to the finished product, process, or consumer. Final selection of method variables should be based on the individual requirements of the system being monitored.

It should be recognized that there is no single method that is capable of detecting all of the potential microbial contaminants of a water system. The methods used for microbial monitoring should be capable of isolating the numbers and types of organisms that have been deemed significant relative to in-process system control and product impact for each individual system. Several criteria should be considered when selecting a method to monitor the microbial content of a pharmaceutical water system. These include method sensitivity, range of organisms types or species recovered, sample processing throughput, incubation period, cost, and methodological complexity. An alternative consideration to the use of the classical “culture” approaches is a sophisticated instrumental or rapid test method that may yield more timely results. However, care must be exercised in selecting such an alternative approach to ensure that it has both sensitivity and correlation to classical culture approaches, which are generally considered the accepted standards for microbial enumeration.

Pharmaceutical Water System Design Operation & Validation

Consideration should also be given to the timeliness of microbial enumeration testing after sample collection. The number of detectable planktonic bacteria in a sample collected in a scrupulously clean sample container will usually drop as time passes. The planktonic bacteria within the sample will tend to either die or to irretrievably adsorb to the container walls reducing the number of viable planktonic bacteria that can be withdrawn from the sample for testing. The opposite effect can also occur if the sample container is not scrupulously clean and contains a low concentration of some microbial nutrient that could promote microbial growth within the sample container. Because the number of recoverable bacteria in a sample can change positively or negatively over time after sample collection, it is best to test the samples as soon as possible after being collected. If it is not possible to test the sample within about 2 hours of collection, the sample should be held at refrigerated temperatures (2  to 8 ) for a maximum of about 12 hours to maintain the microbial attributes until analysis. In situations where even this is not possible (such as when using off-site contract laboratories), testing of these refrigerated samples should be performed within 48 hours after sample collection. In the delayed testing scenario, the recovered microbial levels may not be the same as would have been recovered had the testing been performed shortly after sample collection. Therefore, studies should be performed to determine the existence and acceptability of potential microbial enumeration aberrations caused by protracted testing delays.

Source : USP

Expert Committee : (PW05) Pharmaceutical Waters 05

USP29–NF24 Page 3056

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

Pharmaceutical Water System Ppt,

Pharmaceutical Water Systems,

Purified Water Specification As Per Usp,

Pharmaceutical Water System Design Operation And Validation Pdf,

pharmaceutical water system design operation and validation,

pharmaceutical water system ppt – What is Pharmaceutical water,

purified water & Water for Injection SOP as per usp,

Pharmaceutical Water Systems: Storage & Distribution Systems,

pharmaceutical water system : Inspection of Pharmaceutical water systems,

pharmaceutical water Production : Water purification systems,

Pharmaceutical Water Systems: Types: Water quality specifications,

Pharmaceutical Water System: principles for pharmaceutical water systems

M pharm Pharmaceutics Notes: EVALUATION OF COLON-SPECIFIC DRUG DELIVERY PDF

M pharma pharmaceutics notes - evaluation of colon specific drug delivery systems

M pharm Pharmaceutics Notes is made available for you guys on this day on the topic EVALUATION OF COLON-SPECIFIC DRUG DELIVERY SYSTEMS. Please have a look at it.

 

EVALUATION OF COLON-SPECIFIC DRUG DELIVEY SYSTEMS

Various in vitro and in vivo evaluation techniques have been developed and proposed to test the performance and stability of colon-specific drug delivery systems.

 

  1. In vitro dissolution testing

Dissolution testing has been an integral component in pharmaceutical research and development of solid dosage forms. It provides decisive information on formulation selection, the critical processing variables, in vitro/in vivo correlation and quality assurance during clinical manufacturing. In order to provide this information, dissolution testing should be conducted in physiochemically and hydrodynamically defined conditions to simulate the environment that the dosage form encounters in the GI tract. Currently, four dissolution apparatus are recommended in the USP to accommodate different actives and dosage forms: basket method, paddle method, Bio-Dis method and flow-through cell method. However, certain constraints associated with USP dissolution methods were recognized, especially in the dissolution evaluation of complex controlled release drug delivery systems for oral application, and modification of USP dissolution methods to evaluate such delivery systems was deemed necessary (Pillay and Fassihi, 1999). For in vitro evaluation of colon-specific drug delivery systems, the ideal dissolution testing should closely mimic the in vivo conditions with regard to pH, bacteria, types of enzymes, enzymatic activity, fluid volume and mixing intensity.

 

  1. Conventional dissolution testing

Dissolution testing of colon delivery systems with the conventional basket method has usually been conducted in different buffers for different periods of time to simulate the GI tract pH and transit time that the colon-specific delivery system might encounter in vivo (Rudolph et al., 2001). For example, Takeuchi et al., (2000) assessed the dissolution of spray-dried lactose composite particles containing alginate-chitosan complex as a compression coating in pH 1.2 and 6.8 buffers. Results indicated that such dry-coating showed excellent acid-resistance and prolonged induction periods for drug release.

M pharma pharmaceutics notes - evaluation of colon specific drug delivery systems

USP Dissolution Apparatus III (reciprocating cylinder) was employed to assess in vitro performance of guar-based colonic formulations. Because of the unique setup of dissolution apparatus III (i.e. the dissolution tubes can be programmed to move along successive rows of vessels), drug release can be evaluated in different medium successively. Wong et al., (1997) evaluated several guar-based colonic formulations using apparatus III in simulated gastric fluid (pH 1.2), simulated intestinal fluid (pH 7.5) and simulated colonic fluids containing galactomannanase. As expected, when compared with drug release in simulated gastric and intestinal fluids, results showed that drug release was accelerated in the colonic fluid due to the presence of the galactomannanase that could hydrolyze the guar gum.

Despite the simplicity and convenience, conventional dissolution testing primarily provides essential information on the processing specifications of a colon-specific delivery system rather than on the validity of the system design. For those delivery systems triggered by bacteria in the colon, the conventional dissolution testing appears unlikely to be predictive of in vivo performance. Additional factors that make conventional dissolution testing of colon-specific drug delivery systems less predictive of its in vivo performance are scarcity of fluid and reduced motility in the colon. One function of colon is to absorb water (Debongnie and Phillips, 1978) and thus condense the luminal contents into semisolids. This would influence the drug release from the system and diffusion within luminal contents.

 

  1. Alternative method for evaluation of colon-specific delivery system in vitro

To overcome the limitation of conventional dissolution testing for evaluating the performance of colon-specific delivery systems triggered by colon-specific bacteria, animal caecal contents including rats (Rubinstein et al., 1993), rabbits (Larsen et al., 1989), and pigs (Larsen et al., 1989) have been utilized as alternative dissolution medium. Because of the similarity of human and rodent colonic microflora, predominantly comprising Bifidobacterium, Bacteroides and Lactobacillus, rat caecal contents were more commonly used in the dissolution studies. Rat caecal contents were usually prepared immediately prior to the initiation of drug release study due to the

anaerobic nature of the cecum. Rats were anaesthetized and the cecum was exteriorized for collection of the contents. The caecal contents were diluted with phosphate-buffered saline (PBS, pH 7) to obtain an appropriate concentration for release study. This step was conducted under CO2 or nitrogen to maintain an anaerobic environment. The drug release studies were generally carried out in sealed glass vials at 37 0C for a defined period of time. Samples were withdrawn at different intervals for analysis (Rubinstein et al., 1992, 1993; Yang et al., 2001).

 

In the present in vitro study, the volume of dissolution fluid, containing rat caecal contents, was only 100 ml in order to simulate the fluid volume of the colon. Apparatus 2 is not suitable since the wider paddle blade (diameter 75 mm) can not be dipped in the dissolution fluid contained in the beaker (diameter 55 mm).

USP apparatus 3 was used for the evaluation of guar gum formulations meant for colonic drug delivery (Wong et al., 1997). In this study the authors used water soluble enzyme, galactomannase, at a concentration of 0.01 mg/ml. The level of polysaccharidases in 4 g of rat caecal contents used in the present study, though not estimated, may be far less than what was used by Wong et al., (1997). Hence, it is necessary that the guar gum formulations be continuously in contact with the dissolution fluid for better access to the caecal enzymes. This could be achieved by the use of USP apparatus 1. Moreover, the use of USP apparatus 3 also results in settling of the rat caecal contents in the bottom of the vessel. The maintenance of an anaerobic environment in USP apparatus 3 may also be problematic. Because of these reasons, USP apparatus 1 with slight modifications was used in the present study to evaluate guar gum as a carrier in the form of compression coat for colon-specific drug delivery. Further, earlier workers (Ashford et al., 1993b, Krishnaiah et al., 1998) also used apparatus 1 for the evaluation of colonic delivery systems.

 

  1. In vivo evaluation of colon-specific drug delivery systems

As in other controlled release delivery systems, the successful development of a colon-specific drug delivery system is ultimately determined by its ability to achieve colon-specific drug release and thus exert the intended therapeutic effect. When the system design is conceived and prototype formulation with acceptable in vitro characteristics is obtained, in vivo studies are usually conducted to evaluate the site specificity of drug release and to obtain relevant pharmacokinetics information of the delivery system. Although animal models have obvious advantages in assessing colon-specific drug delivery systems, human subjects are increasingly utilized for evaluation of this type of delivery systems with visualization techniques such as γ-scintigraphy imaging.

  1. Animal studies

Different animals have been used to evaluate the performance of colon-specific drug delivery systems, such as rats (Van den Mooter et al., 1995; Tozaki et al., 2001), pigs (Friend et al., 1991; Gardner et al., 1996), and dogs (Yang et al., 2001). To closely simulate the human physiological environment of the colon, the selection of an appropriate animal model for evaluating a colon-specific delivery system depends on its triggering mechanism and system design. For instance, guinea pigs have comparable glycosidase and glucuronidase activities in the colon and similar digestive anatomy and physiology to that of human (Hawksworth et al., 1971), so they are more suitable in evaluating glucoside and glucuronate conjugated prodrugs intended for colon delivery.

Friend et al., (1991) evaluated the therapeutic efficacy of dexamethasone-β-D-glucoside with dexamethasone in guinea pigs with experimentally induced IBD (Friend et al., 1991). Even though guinea pig is the preferred animal model to investigate the in vivo performance of certain colon specific delivery systems, it is difficult to administer the delivery system orally.

Rats were also used to evaluate colon-specific drug delivery systems based on azo-polymers or prodrugs containing azo bonds because the distribution of azoreductase activity in GI tract is similar between rats and human subjects (Renwick., 1982).

Another animal commonly used to evaluate oral controlled release delivery systems is the dog (Renwick, 1982). The in vivo performance of CODES™ was evaluated in beagle dogs using acetaminophen as a model drug and lactulose as the matrix-forming excipient in the core tablet (Yang et al., 2001).

It is well recognized that significant differences exist between human subjects and commonly used laboratory animals in GI tract anatomy and physiology, including GI transit time, pH, distribution of enzyme activity, population of bacteria, etc. Therefore, the data obtained from animal models should be interpreted with caution.

 

  1. Gamma-Scintigraphy

In most cases, conventional pharmacokinetic evaluation may not generate sufficient information to elucidate the intended rationale of system design. γ-Scintigraphy is an imaging modality, which enables the in vivo performance of drug delivery systems to be visualized under normal physiological conditions in a non-invasive manner. Through γ-scintigraphy imaging, the following information regarding the performance of a colon-specific delivery system within human GI tract can be obtained: the location as a function of time, the time and location of both initial and complete system disintegration, the extent of dispersion, the colon arrival time, stomach residence and small intestine transit times.

The in vivo performance of the colonic delivery system based on pectin and galactomannan coating was also evaluated in healthy human subjects with γ-scintigraphy together with conventional pharmacokinetic analysis using nifedipine as a model drug (Pai et al., 2000). Overall, γ-scintigraphic results demonstrated that it took 5.44 h for the tablets to reach the ascending colon in 92% of 12 subjects. Upon arrival in the ascending colon, approximately additional 1 h was required to initiate the tablet disintegration. The mean plasma concentration of nifedipine was negligible for more than 5 h post-dose, and then increased rapidly. The pharmacokinetic profile exhibited a good correlation with the scintigraphic results. In essence, γ-scintigraphic evaluation of a colon-specific drug delivery system provides ‘proof of concept’, i.e. visualization of system disintegration event and ascertainment of disintegration location in the GI tract.

 M pharma pharmaceutics notes – evaluation of colon specific drug delivery systems PDF doc M pharm Pharmaceutics Notes EVALUATION OF COLON-SPECIFIC DRUG DELIVEY SYSTEMS

  1. Roentgenography

The inclusion of a radio-opaque material into a solid dosage form enables it to be visualized by the use of X-rays. By incorporating barium sulphate into a pharmaceutical dosage form, it is possible to follow the movement, location and the integrity of the dosage form after oral administration by placing the subject under fluoroscope and taking series of X-rays at various time points. This technique was used by Dew et al., (1982) to evaluate a capsule dosage form coated with Eudragit S to deliver orally ingested drugs to the colon using barium sulphate as a radio- opaque material.

Table 4. Marketed colon specific drug delivery systems

 

Drug Trade NameCoating Polymers
Mesalazineclaversa®

Asacolitin

Mesazal

Asacol

Eudragit® L100

Eudragit® S

Eudragit® L100

Eudragit® S

BudesonideEntrocort®

Budenofalk®

Targit®

Eudragit® L100-55

Eudragit® S

Coated Starch Capsule

SulfasalazineAzulfidine

 

Colo-Pleon

Cellulose acetate phthalate

 

Eudragit® L100-55

 

Colon – ANOTOMY & PHYSIOLOGY OF COLON Functions Pharmacology Notes

B Pharmacy M pharmacy Study Material Pharmacology Notes PDF DRUGS SUITABLE FOR COLONIC DRUG DELIVERY