Pharmaceutical Equipment

Pharmaceutical equipment

In today’s life pharmaceutical products hold a very important position.  Most of us in our daily life need them some way or the other.  There is no respite from this by any means for the masses.  There are different types of pharmaceutical equipment available for use.  The list is quite big and has difference in use for different purposes.  Today we look at some of the most commonly used pharmaceutical equipment that are generally in use.

Pharmaceutical equipment Basics

Starting with the Automated/Integrated Workcell, it is quite often used in the Pharmaceutical industry.  It runs on quite a complex procedure and has got different types of intricacy with it.  Then there is the analytical balance that is used basically for class of balance designed to measure small mass in the sub-milligram ranges.  It has an enclosed dust door that help to provide a perfect pin point measurement.  Another one of the most important equipment that is used is termed as Autoclave.  This works as a pressure chamber.  It helps to carry out complex and difficult industrial processes.  It requires elevated temperature and pressure which is quite difference from that of the ambient air pressure.  Next is the BOD Incubator.  It is one of the finest pieces of incubator that works on low temperature.  There are different other types of other equipment that are used which provides the best result in pharmaceutical testing.

Now selection of a perfect equipment for a specific work is very important and requires years of experience and exposure to pharmaceutical work.  One needs to go through different stages of learning before one can get assured of the right equipment for the right process in action.  This is very much needed as the accuracy of the test depends entirely on the selection of apparatus and equipment in use.  Any inefficiency in this process can led to severe disaster in the result of the work or experiment done for manufacturing of pharmaceutical.  It will severely effect the compound manufacturing procedure which in turn can affect the patient or the consumer a great deal and would certainly have reverse and side effects once taken.

The quality of the finished product or rather the manufactured product much depends on the suitability and the level of the technology in use.  Most complex composition manufacturing needs complex procedures and in this case pharmaceutical equipment play a very very important part in the whole process.  Most of the pharmaceutical process today works on an automated process and involves less amount of manual involvement, but still the core of the process must always be guided in a proper way.  It must be always taken into consideration the amount of compound chemicals used, its form and proper combination of different compounds in a perfect percentage.

Pharmaceutical Equipment

Thus it can be easily concluded that Pharmaceutical equipment play a major part when the composition is made or being prepared for use.  It should always be noted that selection of proper equipment is very necessary to get cent percent final result.  It must also be noted that most of the pharmaceutical equipment that are being used runs automatically and needs less manual interference, but as stated above proper guidance is what is required as any lack of monitoring can provide an undesirable result to the finish product.  Most of the compound compositions used today are intricate and thus requires high end, sophisticated and heavy pharmaceutical equipment to use.  The bottom line is that in order to get the most and the best result of the pharmaceutical product one needs to heavily depend on pharmaceutical equipment that are being in use.

Preliminary Hazard Analysis (PHA) Determine Equipment Re-qualification Frequency

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Preliminary Hazard Analysis (PHA) Utility to Determine Equipment and Instrument Re-qualification Frequency

Preliminary Hazard Analysis (PHA) Utility to Determine Equipment and Instrument Re-qualification Frequency

An Introduction to Equipment Qualification

The pharmaceutical industry induces full of experiments and it often requires conducting batch reactions using toxic or flammable materials. In many cases, complex chemical reactions are carried out with significant energy release. Such exothermic reactions processing can cause fire, explosion or runaway reaction hazards and these are quite life threatening for personnel and facilities. Equipment qualification is a critical step in overall process validation (PV), typically referred to as Stage 2A of the PV life cycle. It is outlined in many regulation and guidelines, including the FDA’s 2011 Process Validation Guidance and Annex 15 of the EU GMP, among others.

While handling the Equipment, one is likely to face the ambiguity of how often to do a given task or activity using them. It is necessary for the equipment to be periodically re-qualified if there is a performance dip with consistent working to ensure the quality of products. Here the focus is on the re-qualification decision-making framework based on the use of the preliminary hazard analysis (PHA), a tool used in quality risk management.

Preliminary Hazard Analysis (PHA) Utility to Determine Equipment and Instrument Re-qualification Frequency

Prior to use in production or quality control testing all new equipment should require passing through all stages of qualification such as

  • Design qualification (DQ)
  • Installation qualification (IQ)
  • Operational qualification (OQ)
  • Performance qualification (PQ)

A robust equipment qualification program is appropriate based on the uses and risks of the equipment. The activities of each of these qualification steps should be well documented, to provide evidence that the equipment is fit for its intended purpose, and those records should be available for review by request.

Stages of equipment and instrument qualification

Figure 1: Stages of equipment and instrument qualification

In the figure above, if we follow the illustration we see that once the equipment has been initially qualified, the qualification program should speak to the periodic re-qualification of equipment. It is a part of implementing any changes through a defined change control process impacting the qualified state of the equipment. Based on the criticality of the equipment used in production or on the quality control testing of products the extent of the re-qualification should be done.  Documentation of the periodic review of pertinent data is indispensable to confirm that a process/method/system continues to consistently produce a result meeting predetermined acceptance criteria.

PRINCIPLES OF QUALITY RISK MANAGEMENT

Two primary principles of quality risk management in the pharmaceutical industry are:

  • The risk evaluation of quality should be based on scientific knowledge and concern about the protection of the personnel and facilities.
  • The quality risk management process should be commensurate with the level of risk with respect to the level of effort, formality, and documentation.

ICH Q9 on Preliminary Hazard Analysis (PHA)

As continuing to the question of “When or at what frequency should the periodic review is performed?”  How should one structure the program to help the user determine when to perform the review? What guidelines to follow to create this aspect of the qualification program?

The answer to these is to perform the ICH Q9 (Quality Risk Management) – the risk management tool PHA. According to ICH Q9, the definition of PHA is that it is a tool to analyse hazardous situations and events that might cause harm, to estimate probable hazards in occurrence for a given activity, facility, product or system based on applying prior experience or knowledge of a hazard or failure to identify future hazards.

The tool consists of the following components:

  • identification of the possibilities that the risk event happens
  • qualitative evaluation of the extent of possible injury or damage to health as an outcome
  • using a combination of severity and likelihood of occurrence, relative ranking of the hazard is given
  • the detection of the possible remedial measures

Figure 2 denotes the PHA worksheet. If we can build a worksheet to organize the analysis and assist with the facilitation of the activities, the PHA tool could essentially address all the review of the parameters, as well as correlate the risk priority ranking to a periodic review frequency for the subject equipment.

It requires team expertise in the quality risk management process, how to use the PHA tool, scoring criteria, and key definitions. It generally consists of equipment owners, process owners, and quality assurance to perform the analysis possessing a strong understanding of the whole hazard analysis. The inputs of each column to the worksheet are directed and provided by a two-step triage approach using risk blocks scored against criteria as high, medium, and low rankings as in Tables 1, 2, and 3.

Figure 2: PHA worksheet example

 

 

 PHA work sheet example

 

 

Table 1: Severity Rankings

Severity Rankings

 Table 2: Probability (Occurrence) Rankings

Probability (Occurrence) Rankings

 Table 3: Detectability Rankings

Figure 3: Risk class determination

The preliminary risk class based on severity and probability (or occurrence) was first determined as in Figure 3.

Risk priority ranking

Figure 4: Risk priority ranking

Risk priority ranking

Table 4: Example of Periodic Review Frequency

Further the hazard parameters are evaluated against detect-ability, resulting in a risk priority ranking (Figure 4). It correlates to the periodic review frequency for the subject equipment (Table 4). Once the worksheet is completed with input from team members, the periodic review frequencies should be reviewed and agreed to by all. The following PHA worksheet (Figure 5) provides an example of a completed analysis activity.

Figure 5: PHA worksheet example — completed analysis activity

 

PHA worksheet example — completed analysis activity
PHA worksheet example — completed analysis activity

Inferences drawn about how this method of hazard analysis can be beneficial

  • The PHA tool enables to build a usable worksheet allowing all members of the team to participate in the risk analysis activity to provide subject matter expertise, voice concerns, and promote issues for further discussion.
  • Additionally, by facilitating the team meetings, time schedules were managed and those issues that were a challenge were tabled and discussed offline.
  • At the end of each completed worksheet, team members provide feedback regarding the risk analysis activity noting the efficient use of time, effective use of risk management tools, and delivery of risk priority rankings for subject equipment in correlation with the periodicity frequency.
  • Therefore, using a risk management tool such as PHA, a periodic review frequency can be identified and applied to qualified equipment. This enables a timely recheck of the equipment by means of pertinent data like manufacturing performance trend data, change history, and/or deviation history and that in turn would help in assuring consistent production results meeting the predetermined acceptance criteria.

Formulation Equipment List – Pharmaceutical Formulation Machinery PDF

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Formulation Equipment List - Pharmaceutical Formulation Machinery PDF

In pharmaceuticals, formulation (or dosage form) refers to the creation of a structure such as a capsule, a pill, tablet, or an emulsion, prepared according to a specific procedure or “formula”. Competently designed formulations for particular applications are safer, more effective, and more economical than any of their components used singly. There are a range of automated and semi-automated machines and equipment that can assist in the highest quality formulation of pharmaceuticals.

The pharmaceutical industry has the most precise requirements and manufacturing guidelines in terms of quality. As a result, it is critical that pharmaceutical manufacturing equipment comply with good manufacturing practice (GMP). Pharmaceutical manufacturing equipment includes a wide variety of equipment, such as capsule filling machines, x-ray inspection systems, and spray drying accessories. In order to ensure precise manufacturing and formulation development, almost every process can be automated. As a result, there is a piece of pharmaceutical manufacturing equipment involved in every step. 

PDF Formulation Equipment List 

Pharmaceutical Formulation Machinery

  • Economic tablet press
  • Single rotary tablet press
  • Laboratory capsule filler for liquid solutions
  • Automatic capsule filler for liquid solutions
  • Automatic laboratory capsule filler
  • Contained capsule filler
  • High-yield capsule filler
  • Automatic tablet coater for lab scale
  • Tablet auto coater for lab scale
  • Microencapsulation system for your drug delivery system
  • Waste minimization weight sorter for tablets & capsules
  • High capacity weight sorter for tablets & capsules
  • Major Formulation Equipment
  • Homogenizer
  • Filler
  • Vector FLM-1 and FLM-3
  • fluid bed processors
  • High Shear Granulator 
  • Planetary Mixer
  • High shear granulator/blender 
  • V blenders: 
  • Single station tablet press
  • Instrumented sixteen station tablet press (“B” Tooling)
  • Benchtop encapsulation machines (2 pc. Hard-shell)
  • Various semiautomatic compression and encapsulation machines
  • Various granulation and compounding equipment
  • Capsule Sealer & Capsule Printer
  • Perforated coating pans (15″, 19″, 24″ & 36″)
  • Dome extruder
  • spheronizer
  • Comil
  • Wurster columns 
  • Conventional coating pan
  • Formulation Equipment List - Pharmaceutical Formulation Machinery PDF

Today’s technology has much improved with the advancement of time.  Science has provided us with different ways in order to motivate our life and get the best out of it.  A revolution has also taken place in terms of manufacturing and processing machinery as well.  Over the last decade things seems to have change drastically and has provides us with a new horizon of opportunities that we can boost with and help our life grow bigger and better over the coming days.  Manufacturing and processing machinery today has greatly changed over the course of time and most have touch different avenues and left a mark for itself to carry on with.  Today we are going to discussed about some of the formulation and processing machinery and next articles we see how it has changed human life.

List of Medical Laboratory Equipment | Lab Supplies | Clinical Pharma Lab Devices

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List of Medical Laboratory Equipment lab supplies instruments used clinical and pharma lab

In this article we deal with the list of Medical Laboratory Equipment and all lab supplies and Instruments.  Clinical  Laboratory Devices are also included in the list. Pharmaceutical equipment always play a vital part in production of the pharmaceutical products.  There are wide range of products that are involved with this process from big to small, light to heavy, semi-automated to fully automated, metal to steel and of different shapes and sizes.  Today we try to list up some of the most important of the pharmaceutical equipment that are generally used in the production unit.

List of Medical Laboratory Equipment

The list is as follows below:

List of Medical Laboratory Equipment lab supplies instruments used clinical and pharma lab

  • Blood Pressure Systems/Blood Pressure Monitor
  • Capnograph/Capnography Monitor
  • Lab Animal Exercise / Walking System
  • Laboratory Animal Anaesthesia System
  • Physiological Monitor
  • Cryogenic Shippers / Cryoshipper
  • Laboratory Refrigerator Freezer
  • Liquid Nitrogen Canister / Liquid Nitrogen Dewar
  • Liquid Nitrogen Freezer / LN2 Freezers
  • Minus 20 freezer (-20C to -40C Freezers)
  • Minus 80 Freezer (-86 Freezer)
  • Plasma Freezer / Blood Bank Freezer
  • Tissue Freezer
  • Ultra Low Temperature Freezer (ULT Freezers)
  • Laboratory Animal Monitoring
  • Forensic Workstation / Forensic Hood
  • Laboratory Freeze Dryer
  • Laboratory Hoods
  • Cage Changing Hoods
  • Cell Processing Work Station
  • Glove Boxes
  • IVF Workstation
  • Laboratory Fume Hoods
  • Laminar Flow Hoods / Biological Safety Cabinets
  • PCR Workstation / PCR Cabinet
  • Reverse Flow Workstations
  • Laboratory Incubators
  • CO2 Incubator / Cell Culture Incubator
  • Dual Polarization Interferometer
  • Quartz Crystal Microbalance (QCM)
  • Surface Plasmon Resonance Imaging (SPR Imaging)
  • Blood Chemistry Analyzer / Blood Analyzers
  • Albumin Analyzers (Albumin Testing)
  • Automated Blood Gas Systems
  • Automatic Biochemistry Analyzer / Automated Biochemical Analyzer
  • Blood Bank Automation System / Automated Blood Bank System
  • Blood Gas Analyzers
  • Blood Lactate Analyzer / Blood Lactate Testing Equipment
  • Chemistry Analyzer / Clinical Chemistry Analyzers
  • External Quality Assessment (EQA)
  • HbA1c Analyzer / Haemoglobin Analyzer
  • Haematology Analyzers
  • Haemostasis Analyzer
  • Immunoassay Analyzer
  • Immunoassay System
  • Immunochemistry Analyzer
  • Laboratory Blood Glucose Analyzers
  • Cell Counters / Colony Counters
  • Automated Cell Counter
  • Bacterial Colony Counters
  • Colony Counting Apparatus
  • Disintegration Tester / Disintegration Apparatus
  • Dissolution Apparatus / Dissolution Tester
  • Dissolution Sampler / Dissolution Sampling System
  • Dissolved CO2 Meter / Dissolved Carbon Dioxide Analyzer
  • Cell Disruptor
  • Cell Harvesting System
  • Off-gel Fractionators/ Off-gel Electrophoresis System
  • UV Trans-illuminator
  • CO2 Transmitter / Carbon Dioxide Transmitter
  • Colony Picker
  • ADME-Tox Screening System
  • Amino Acid Analysis System / Amino Acid Analysis Instruments
  • Automated Hit Picking Systems
  • Automated Proteomics Workcell
  • Bio molecular Interaction Analysis
  • Automated Bio molecular Interaction Analyzer
  • Electrophoresis Analysis
  • Capillary Electrophoresis Instrument
  • Digital Gel Photography System / Gel Image Capture System
  • Electrophoresis Power Supply
  • Gel Electrophoresis Instrument
  • Flow Cytometry
  • Automated Flow Cytometry System
  • Flow Cytometer
  • Friability Tester / Friability Test Apparatus
  • Gas Chromatograph Mass Spectrometer (GC MS Instrument)
  • Gas Chromatography Equipment
  • Gas Chromatograph / GC System (GC Instruments)
  • Gas Chromatograph Mass Spectrometer (GC MS Instrument)
  • GC / GC MS Software
  • GC Auto-sampler / GC Headspace Auto-sampler
  • GC Fraction Collector
  • GC Gas Regulators / High Purity Gas Regulator
  • Multidimensional Gas Chromatography (MDGC / GCxGC)
  • Portable GC MS
  • Glass Bead Autoclave
  • Glass Bead Sterilization / Laboratory Glass Bead Sterilizer
  • Hyper-spectral Image Analysis
  • Chemical Imaging Systems (NIR / Raman)
  • Hyper-spectral Camera / Hyper-spectral Imaging Systems
  • Immuno-blotting Equipment
  • Blot Strip Cutter
  • Cryogenic Refrigerator / Cryofreezer
  • Animal Pulse Oximeters
  • Animal Temperature Probe
  • Animal Ventilator
  • Animal Warmers
  • Cryogenic Refrigerator
  • Animal Pulse Oximeters

Tablet Making Machine India – Cost Price Manual

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Tablet Making Machine

In today’s date “tablets” h0old an essential part of our life.  Most of us consume tablets everyday be it a teenager, middle aged or an old man.  Now consumption of tablets has become a part of our life for most of us if not all.  Looking back at the process of making tablets in the Industry, it is a typical process and passes through certain phases before it is completely done and sealed pack for selling.  Today we will be hereby discussing how tablets making machine is helping to make tablets in short and a precise way.

Tablet Making Machine India – Cost Price Manual

The process

The tablet making machine is generally known as the Tablet Press and consists of two different types mainly.  One is known as the single-punch and another is called the rotary tablet presses.  The punches and dies used for making tablets come in different variety of sizes, shapes, designs and can be easily customized according to need and generally is manufactured with manufacturer codes and scoring lines which makes it more easier for the user to break the tablet at once.  Now depending on the size, shape, material and configuration of the press, the machine (press) can produce from around 250,000 to over 1,000,000 tablets an hour on a general basis as per stats obtained from various production houses.  Now speaking about its mechanism, tablet presses work in a very high speed and takes the form of a rotating turret.  It simply holds number of punches as customized before production.  Once it starts to rotate around the turret, the punches come close in contact with the cams in use and control the punches in a vertical position for the tablets to get manufactured.

The tablet press that we are speaking of here has a simple mechanism to work with.  The main objective of the machine or device is to compresses powder into tablets which comes out in a uniform manner in terms of shape, size and weight as per the requirement of the production house.  The press has got a high potential and generally used to manufacture tablets of different types in conjunction to the variety of materials used.  This can include illicit drugs, pharmaceuticals, cleaning products and cosmetics as well.  The granulated material in order to be given a proper shape into a tablet is firstly metered into a cavity form.  This is done by the use of two punches and a die.  Once this is done, the punches are pressed together with great force.  This in return fuses the materials together giving a shape of a tablet.  For most of the tablet press machines the most integral part of it remains the same ie.  Hopper, Die, Punches, Cam track and feeding mechanism.

Tablet making machine cost manual price

Different types of machine

Now speaking about tablet press and its actions, it is has been found that this tablet making machine comes in two different variants.  One is called the single station or eccentric press and another is the multiple station or popularly known as the rotary tablet press.  The Single station is relatively compact in nature to that of the multiple one and is basically easier to operate among the two in comparison.  It is used to produce chewable tablets, Effervescent and other compressed tablets.  Whereas speaking about the multiple station, its setting up is much more streamlined and can be fined tuned for more customization than that of the two with much higher production rate and obviously the capability of it is immense when compared.  The machine has capability of ejecting, filling and removal of the tablet as well after compression procedure.

Top Pharmaceutical Machinery Manufacturers in India – Pharma Machinery Suppliers

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Pharmaceutical Machinery Manufacturers in India

Pharmaceutical Machinery Manufacturers in India: In today’s world when most of the countries are on the verge of extending their capabilities in each and every spheres of life and implementing new ideas and innovations to satisfy life on a larger scale, India is also on the same track as well.  When pharmaceutical machinery manufacturing in India is concerned, today India is considered to be one of the best in the world and is simply reaching new heights of success on a whole.  Hereby we try to figure out some of the prime manufactures in India who are a leading brand in manufacturing pharmaceutical machinery and about their activities in short.

Pharmaceutical Machinery Manufacturers in India

  • Pharma Tech International

Pharma Tech International is considered to be one of the finest Pharmaceutical machinery manufacturers from India.  The company came into existence in the year 2007 with a current annual turnover of Rs 50 lacks to 1 Crore according to stats obtained from sources.  This company boots itself in producing high profile machines like automatic capping machine, capsule section machinery, ointment section machinery, tablet section machinery, crushing machines, globule making machines and the list goes on.  The products are really durable in nature with capabilities of performing accurately and mostly are fully automatic in nature and require less amount of human interference.

  • Prism Pharma Machinery

Prism Pharma Machinery from the land of Gujarat came into existence in the year 2003.  They provide some of the best durable and highly sophisticated pharmaceutical machinery.  With a reputed base and trust of serving this industry from a long time they boost their capabilities in providing machines like high shear mixer granulation, RMG, Tray dryer, oscillating granulator, bin blender, Tumbler bender, Drum mixer blender, mass mixers and others.  They are best in making Roll compactor, Vibro shifter, basket extruder, movable hoist, automatic tablet coater, colloid mill, capsule polishing machine, sealing machine and the list is endless.

Today they stand as one of the finest in the business and provide some of the best products for pharmaceutical use.

Pharmaceutical Machinery Manufacturers in India

  • Harrison’s Pharma Machinery Pvt. Ltd

This ISO certified company from Delhi since its inception days in the year 1983 have always been in the limelight with the quality of machines they manufacture and have the repute also of providing wide range of products as well.  The list is long and some of the wide variety of products they manufacture includes ointment plant, lami tube filling & sealing machine, stainless steel storage tank, Mini Pulverizer, Cyclone Type Pulverizer, Powder mixer and rotary bottle washing machinery as well.  They also produce some of the finest quality machines in relation to laboratory use, syrup manufacturing, multipurpose equipments and many more.

Top Pharmaceutical Machinery Manufacturers in India – Pharma Machinery Suppliers

  • Lohashilpi

This is another innovative manufacturer from the state of Kerala which is considered to be one of the finest pharmaceutical machinery manufactures in India.  They have a huge number of productivity which includes Liquid filling machines, Semi automatic blister sealing machines, Hydro pneumatic blister trimming machines.  They are capable of providing some of the best quality products available in the market today with capabilities of producing high range products for use.  They also deal in automatic rubber machinery, packaging solutions and manufacturing machines yielding rubber accessories as well.

Given above are some of the finest pharmaceutical machinery manufacturers from India who really have done a great job and helped largely improving the quality of pharmaceutical products on a whole.  There are different other companies as well which do have the similar potentials and produce a great variety and quality machines that not only improve the quality but also improves the volume of manufacturing.

Pharmaceutical Machinery Manufacturers in Mumbai – Pharma Navi Bombay

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pharma machinery manufacturers in navi mumbai

Pharmaceutical Machinery Manufacturers in Mumbai: Today we will be concentrating on some of the best pharmaceutical machine manufacturers from Mumbai, India who have who have constantly given enough effort and hard work to make world class product and compete in the market on a global scenario.  Most of them have years of expertise in this specific field and have managed to earn goodwill in the market by their effort.  Here are few of the most trusted brands from Mumbai who develop and manufacture pharmaceutical machinery.

Pharma machinery manufacturers in navi mumbai

  • Jay Pharma Machinery Equipments

This is one of the most trusted companies that are situated in the heart of Mumbai city, India.  Over the last six years the company has grown from strength to strength increasing the numbers of their clients with good service and maintenance of quality product.  This company has the perfect expertise in manufacturing pharmaceutical machinery like wet mixtures, milling machines, washing system, blender, filter press, Ointment Manufacturing Plant, Inline Homogenizer, pallets, cooting system and the list goes on and on.  Today Jay Pharma Machinery Equipments stands high among its rival companies serving the best out of the best.

  • Bright Pharma Machinery

Situated in Andheri, East Mumbai, Bright Pharma Machinery this company is one of the leading manufacturers of Pharmaceutical machinery along with production of cosmetic, bio product machinery as well.  From 20 years this company has been working in the market with infusing and implementing new ideas for the betterment of the business.  It has expertise in designing and manufacturing machines in relation to ointment/cream manufacturing plant, transfer pump, metering pump, filtration unit, cream manufacturing plant, fluid bed dryer, coating pan, spray coating machine, Vibro shifter, rapid mixer granulator and the list is a long one indeed.  This company over the years has a good repute of producing the best when it comes to business on a whole.

  • Prince Pharma Machinery Bombay

Incorporated in the year 2007 at Mumbai, Prince Pharma Machinery has the perfect expertise in providing impeccable quality of pharmaceutical machinery that are of world class standards.  Since its establishment, the company has paved itself to the top with a team of members who have a vision to think big and innovative in the field of pharmaceuticals.  Today they have an arsenal of some of the best machinery which includes manufacturing of fluid bed dryer, Vibro shifter, Mutlil mill, coating machine, starch paste kettle, Zero hold up filter press, tray dryer, Octagonal blender and much more.  This manufacturing unit is considered to be one of the finest in the business today.

pharma machinery manufacturers in navi mumbai

  • Mec Well Pharma Machinery Company – Mumbai

From Thane, Maharashtra Mec Well Pharma Machinery has the perfect capabilities and adequate infrastructure to design and develop some of the most needed pharmaceutical machinery that are of high quality and capable of producing volume productivity.  The company boost itself with manufacture of highly efficient machinery like blending machine, fluid bed dryers, Vibro shifter, blending vessel, liquid manufacturing plant, ointment plant, Ointment Manufacturing Plant, Pharmaceuticals Processing Plant, oral liquid manufacturing plant, pharmaceutical ovens, fermentation tank and the list is endless.  This company today stands as one of the finest manufacturing company and have been serving clients globally with trust and quality.  They have successfully marketed themselves with hard and dedication as one of the best in the business

There are other companies too like Chamunda Pharma Machinery Pvt. Ltd, Harish Pharma Engineeringm Pharma Fab Industries, S K Pharma Machinery Private Limited, Champion Pharma Machines and etc. from Mumbai who are considered to be equally capable, well trusted and rewound when it comes to manufacturing of Pharmaceutical machinery in Mumbai, Maharashtra.

Pharmaceutical Packaging Machinery – Medicines Packing Equipment Types

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Pharmaceutical Packaging Machinery - Medicines Packing Equipment Types

Pharmaceutical Packaging Machinery: In today’s date Pharmaceutical packing machinery hold a very important position when it comes to doing business with the same.  As we all known good packaging not only increased the overall quality appearance of the product but also helps it to do a good branding and provide successful business also.  Today there are different companies who are specialized in this field of work.  They solely work on packing and distributing pharmaceutical packaging.  There are different types of machinery which are uses in this case.  The list is pretty long and most of them are complex in nature whereas there are also simple machinery as well.  Today we are going to discuss about few of the most important Pharmaceutical packaging machinery in short and their use.

Pharmaceutical Packaging Machinery – Medicines Packing Equipment Types

One of the most well known Pharmaceutical packaging machines used very often is Blister Packing Machine.  It is available both for large and small batches of drug processing expediting marketability of Pharma products via blister packing.  Next there is the Pharmaceutical Automatic Capping Machine.  It is used for capping of the pharmaceutical products and is considered to be one of the final steps of ensuring the quality of the product as well.  Next is the Pharmaceutical Filling Machine which simply expedites the current process of packaging.  This filling machine perfectly works for large scale filling used to measure sterility and dispensing of correct volume when in use.  One of the most well-known and widely used machines is Pharmaceutical Ampoule Filling Machine.  This machine is a very complex one and works on a very sophisticated or delicate procedure.  These types of machinery are basically used for pharmaceutical ampoule filling equipment.  The process is a fully automated one and works on a constant basis to provide the required result.  It provides the option of weight checking of product and as well as laser sealing as well.  Another one of the important packaging machinery used for pharmaceutical products is Pharmaceutical Liquid Filling Machine.  It is used for manufacturing of liquid drug suspensions.  This packaging machine is used in variety of forms and use.  It comes in both small and large size.  The operation involves filling of liquid.

Medicines Packing Equipment Types

Now pharmaceutical packaging machinery comes in different price range and in different shapes and sizes.  There are different companies who are best at making these types of machinery.  Some of them are small and some are big production houses.  These production houses basically deal in making pharmaceutical packaging machinery that are all in compliance with FDA standards and maintain a strict protocol as per general guidelines.  Some are semi automatic in nature, some are fully automatic.  When we speak about these type of Pharmaceutical packaging machinery there are different vendor who have earned a good name in the market over the years and have provided world class quality products on a regular basis.  Some of them are Marchesini Group with its headquarters at Italy.  Then there is Mg2 as well from Italy along with Multivac Sepp Haggenmuller.  Bosch and Romaco are two of the most important names that we can add to this list as well and both are from Germany who have the repute of consistently providing quality machinery in this field as well.

Pharmaceutical Packaging Machinery - Medicines Packing Equipment Types

Coming to the concluding part of this discussion, it has been found that these packaging machinery are a very important part of the production of the pharmaceutical products worldwide and provides safety to the finish products as well.  Proper packaging not only ensures the safety of the product but also maintains a proper hygiene to the pharmaceutical products as well which is essential.

Tray Dryer Working Principle

Pharmaceutical Mixing Equipment – Pharmaceutical Blending & Mixing pdf

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Pharmaceutical Mixing Equipment - Pharmaceutical Blending & Mixing pdf

Pharmaceutical Mixing Equipment: Mixing has always been a very integral part of manufacturing pharmaceutical equipment.  In order to form a right pharmaceutical product with proper compositing and content mixing plays a very important and integrated part.  Today we will be looking at some of the well known and primary pharmaceutical mixing equipment that are widely used in the production units for manufacturing of pharmaceutical products.  We try to look at few of them in a very short and precise way.

Pharmaceutical Mixing Equipment – Pharmaceutical Blending & Mixing pdf

Depending on type of mixing we can categorize the procedures accordingly which are as follows:

  • Liquid-liquid mixing

There are different types of mixtures used for mixing liquid with liquid in the pharmaceutical production units.  This process is quite complex and requires additional monitoring.  There are different types of mixers used for this purpose namely, Shaker mixers, Propeller mixers, Paddle mixers, Turbine mixers, sonic and ultrasound devices such as Rapisonic homogenizer.  These equipment are uses for manufacturing antacid suspensions, different emulsions, anti-diarrhoeal mixtures and other such pharmaceutical products.

  • Solid-solid mixing

For solid to solid mixing of pharmaceutical products there are different types of equipments in use on a general basis.  This includes Agitator mixers, Tumbling mixers, Double cone mixers, and V-blenders and others.  These equipments are generally used for mixing of dry (solid base) powders.  These are mainly used for making tablets of various types and sizes.

  • Semi-solid mixing

Then there is semi to solid mixing equipment perfectly designed for this specific purpose also.  For this purpose there are different types of Agitator mixers that are in use like sigma mixers and planetary mixers.  Other than this there is Shear mixer like triple roller mills and colloidal mills as well.  These are basically used for wet granulation procedure while manufacturing tablets and also in the production of ointments as well.  Sigma mixture can also be used in case of solid to solid mixing as well.

Other than the above mixing equipment there are different types of mixtures that are also in use while making up of Pharmaceutical products.  These include tumbling mixer.  These are close vessel mixer rotating about its axis.  They are basically found in double cone, V-mixer and rotating cube as well.  Here the quality of mixing is limited and works on diffusive mixing mechanism.

Then comes Convective mixers which is accompanied with some diffusive and shear mixing.  This machine works typically less than 60 rpm.  Here ribbon blenders are used on a horizontal axis in a static cylinder set on a circular pattern within in a static shell.  Paddles or rotating blades are used in this machine.

Other important pharmaceutical mixing equipments include Conical screw mixer, Muller mixer, Pug mill, Pan mixer, Change can mixer, Banbury mixer and the list is endless.

Pharmaceutical Mixing Equipment - Pharmaceutical Blending & Mixing pdf

On a whole it can be easily said that these different types of mixing equipment are used in order to serve different purposes and to obtain a specific result in the pharmaceutical product manufacturing.  Most of these mixers work on a very complex process and generally have an automatic procedure to work on.  This really is a complex process and needs lot of understand and one must go through years of experience in order to progress and handle these types of machine with care and in a right way.  Without prior knowledge about these type of machine, handling can really be difficult and would produce inverse reaction to the pharmaceutical process.  Most of these equipment are built in a specific way according to their way of action and mostly are brittle in nature and use of pharmaceutical mixing equipments can really be challenging.

Read about Tray Dryer Working Principle

Pharmaceutical Machinery Manufacturers in Ahmedabad -Pharma Machinery

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Pharmaceutical Machinery Manufacturers in Ahmedabad

Ahmedabad has always been a happening place since Independence.  In western India, it is the largest city in the state of Gujarat.  In terms of providing business there is no other state that can ever compete with Ahmedabad and has always been in the limelight for good reasons.  Today we look at some of the best Pharmaceutical machinery manufacturers in Ahmedabad and throw a light about their product and production unit as well.

Pharmaceutical Machinery Manufacturers in Ahmedabad

  • Prism Pharma Machinery

Prism is one of the most trusted brands in Ahmedabad when we speak about manufactures and exporters of pharmaceutical machinery.  Founded in the year 2003, this company with the advent of time has managed to excel its work activities and have successfully gained good reputation.  They provide a wide range of products that includes High Shear Mixer Granulator- RMG, Mass Mixer, Roto Cone Vacuum Dryer, Tablet Press – PTCMD4, Movable Hoist, Fluid Bed Dryer, Spraying System, Lab Scale Mini Tablet Press, Automatic Liquid Syrup Manufacturing, Inline Homogenizer, Preparation vessel, reactor & Storage and the list is endless.  Today Prism Pharma Machinery stands for its quality and goodwill.

  • Ambica Pharma Machines Private Limited

Ambica Pharma Machines Private Limited is considered to be among the best in manufacturing Pharmaceutical machinery from Ahmedabad.  They have a production unit which is well established in manufacturing wide variety of machinery.  The company boosts its capability in producing different types of machinery that includes vial washing machine, automatic high speed 8 head linear Vial liquid filling, 4 head Linear Vial liquid filling, Automatic high speed 2 head injectable liquid filling, powder and liquid filling combo, dry syrup filling machine, injectable powder filling machine, different types of cap sealing machines for pharmaceuticals, screw cap sealing machine, vial aluminum cap sealing machine and the list is endless.  Since its inception the company till date is growing and today stands as a trusted brand in the business.

  • Spark Tech India – pharmaceutical machinery

Spark technologies have always been in the limelight for providing supreme quality of pharmaceutical machinery that are of world-class quality.  Since its inception in the year 1999, this company has got many acclamation from its clients worldwide and today boots its capabilities of solidifying platform of excellence in business.  They provide quality product which includes different types of liquid filling machinery, heavy automatic high-speed syrup filling machinery, washing machines of different kind which are mostly automatic in nature, different types of cap sealing machines for pharmaceuticals and different other machinery that can really improve the quality of pharmaceutical products and its productivity as well.

Pharmaceutical Machinery Manufacturers in Ahmedabad

  • N K Industries

N K Industries situated in Ahmadabad, Gujarat is a pioneer in the field of pharmaceutical machinery production from a long time and hold a good repute for over 35 years which has simply help them to establish a trust between the client and themselves on the global platform.  Their products are of high quality and impeccable productivity.  Some of their products include tablet pill capsule counting filling machine, Auger powder filling machine, capping machine, Ropp capping machine, washing machine, Injectable dry powder filling machine, screw capping machine and many more which rightly have high demands in today’s market.

On conclusion it can be easily said that these are some of the well trusted brands from Ahmedabad that have gained much popularity through their quality productivity.  There are other names too which are equally best whose activities and productivity are as vibrant as that of the above.  All in all, Ahmedabad truly stands as one of the best pharmaceutical machinery manufacturing production hub.

{PDF} Tablet Evaluation – Pharmaceutics Pharmaceutical Apparatus Material PPT

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PDF Tablet Evaluation - Pharmaceutics Pharmaceutical Apparatus Material.JPG

Topic: {PDF} Tablet Evaluation – Pharmaceutics Pharmaceutical Apparatus Material: Tablets are defined as solid unit dosage form of medicaments intended for oral use. They became most popular as they were easy in preparation compared to any other type of dosage forms. But the major drawback exists in its manufacturing. If any minor problem occurs during their manufacturing then the whole batch of the unit should be discarded. It is necessary to avoid any sort of errors during its manufacturing and as a result evaluation of tablets is very important before dispatching of a batch. In the present study, we discussed about the evaluation tests for tablets.

Tablet Evaluation:

Before a tablet is released out into the market it has to pass a few quality checks, which is mandatory. Evaluation of tablet includes the assessment of tablets physical, chemical and biological properties. To studies them the following test are formulated

  •    Appearance,
  • • Size and Shape,
  • • Organoleptic properties,
  • • Uniformity of thickness,
  • • Hardness,
  • • Friability,
  • • Drug Content Uniformity,
  • • Weight Variation Test,
  • • Wetting time,
  • • Water Absorption Ratio,
  • • In vitro Dispersion Time,
  • • In vitro Disintegration Test,
  • • In vitro Dissolution Studies,
  • • Two set of apparatus,

Description:

Appearance:

Appearance is the first most required quality for the acceptance of tablet. General elegance and its identity play a major role for the consumer acceptance. Acceptance of the appearance of batches of the tablet has been done based on the measurement of the following factors like size, color, shape, presence or absence of odor, taste etc. [26-50]. Size and shape

General appearance is the physical appearance of the tablet it has two aspects to address

First one is the patient compliance, if the tablet is appearance is legible and good, it improves the patient compliance.

The second one Is for the manufacturer, it helps him in trouble free manufacturing if there is tablet to tablet, batch to batch and lot to lto uniformity of tablet.

General appearance would include a number of aspects like, size, shape, odor, taste, texture, legibility, identifying marks.

For rapid identification of the tablet and consumer acceptance the tablet are given a specific colour, the colour of the tablet will enable the manufacturer form differentiating the tablet lot.

The uniformity of the colour is important parameter here, the tablet should be free form mottling.

The colour uniformity and gloss of the tablet is evaluated by using reflectance spectrophotometer, tristimulus colorimetric measurement, microreflectance photometer.

Size and shape

Size and shape of a tablet has been determined by its thickness. Size and shape of a tables plays an important role in its patient compliance as the size of the tablet increases it is not much easier for its administration. Micrometer is the devise which is used to determine the thickness of a tablet. It can be acceptable if the batch falls within the ±5% of standard deviation.

Organoleptic properties:

Color should be distributed uniformly without appearance of any signs of mottling. Colour of the tablet should be compared with the standard colour for comparison.

Uniformity of thickness:

To determine the uniformity of thickness random selection of tablets has to be done from each and every batch and need to measure its thickness independently. If the thickness of any single tablet varies then the batch containing that batch will not be dispatched into market

 WEIGHT VARIATION TEST

The weight variation test would be a satisfactory method for determining drug content uniformity of drug distribution. In practice this test is performed by taking 20 tablets, from a batch. 20 tablets are weighed at a time and the average weight is taken. Then the tablet is weighed individually.

 

Average Weight Percentage Difference
130 mg or less 10
More than 130 mg through
324 mg		 7.5
More than 324 mg 5

2) THICKNESS AND DIAMETER (SIZE AND SHAPE)

The thickness of individual tablets is measured with a micrometer, which gives us information about the variation between tablets. Tablet thickness should be within a ±5% variation of a standard value. Any variation in thickness within a particular lot of tablets or between manufacturer’s lots should not be clear to the unaided eye for consumer acceptance of the product. In addition, thickness should be controlled to smooth the progress of packaging.

PDF Tablet Evaluation - Pharmaceutics Pharmaceutical Apparatus Material.JPG

Different shapes and sizes of tablet are available in the market they are manufactured in order to differentiate them based on their purpose of use and quantity of active ingredient, and the age group of the patient who is going to be administered with the drug.

Heart shape tablet signify that they are for the cardiac problems, small toy shape, tablet are manufactured in order to attract children etc.

The shape and size of a tablet would vary based on tooling used in the tablet manufacturing.

The prime consideration here would be the crown size, because if the concavity is very high it many lead to capping, or chipping problem.

The crown size is measured by using micrometer, and sliding caliper scale is used to measure the size of 5 to 10 tablets at a time.

We use Micrometer for tablet thickness

3) UNIQUE IDENTIFICATION MARK:

Pharmaceutical manufacturers in order to differentiate their product from the other manufacturers emboss a special marking g on the tablet. The marking can be an embossing, engraving or printing.

Apart from the company marking there can be imprints which include product code, product name, product potenct,

But care must be taken that the letters that are embossed on the tablet are properly printed without double impression.

5) HARDNESS AND FRIABILITY:

The hardness of the tablet is important for drug products that have bioavailability problem or that are sensitive to altered dissolution release profiles as a function of the compressive force employed. Tablet hardness is the force necessary to break the tablet diametrically. The tablets must be hard enough to withstand mechanical stress during packaging, shipment, and handling by the consumer.

Section <1216> of the USP 24/NF19 outlines a standard tablet friability test applicable to manufactured tablets. Most compounding pharmacy would not have the apparatus specified in Section <1216>. However, there are several hand operated tablet hardness testers that might be useful. Examples of devices are the Strong Cobb, Pfizer, and Stokes hardness testers. The principle of measurement involves subjecting the tablet to an increasing load until the tablet breaks or fractures. The load is applied along the radial axis of the tablet. Oral tablets normally have a hardness of 4 to 8 or 10 kg; however, hypodermic and chewable tablets are much softer (3 kg) and some sustained release tablets are much harder (10-20 kg).

Tablet hardness and strength are the essential to see that the tablet can with the shock and stress during manufacturing packing and transportation, and while handled by the patient.

To test the hardness of the tablet Monsanto tester, Strong-cobb tester, the Pfizer tester, the Erweka tester, the Schleuniger tester are used.

Hardness is sometimes termed the tablet crushing strength. To perform this test the tablets are located between two anvils and force is applied to the anvils, and the strength required to break the tablet is noted. If the tablet is too hard, the disintegration time is long and cannot meet up the dissolution specification, if its too soft, it cannot withstand handling when dealing with processes such as coating or packaging and shipping operations. The force with which the tablet is broken is expressed in kilograms and a hardness of 4Kg is usually well thought-out to be the minimum for satisfactory tablets. Oral tablets have a hardness of 4 to 10kg ; but, hypodermic and chewable tablets  have a hardness of 3 kg  and sustained release tablets have about 10-20 kg.

Pfzier hardness tester was used for measuring the hardness of the formulated Paracetamol tablets. From each batch 3 tablets were taken at random and subjected to test. The mean of these 3 tablets were calculated.

Friability is the tested for a tablet to see weather the tablet is stable to abrasion or not, it is tested by using Roche friabilator. This is made up of a plastic drum fixed with a machine which rotated at 25 rpm for 100 revolutions. And then the twenty tablets which were weighed prior to the test are taken out of the drum and cleaned with a cloth and weighed once again, the weight variation must not be less than 0.5 to 1.0% for an conventional tablet.

6) WEIGHT VARIATION:

Weight variation test is performed to check that the manufactured tablets have an uniform weight.

As per USP twenty tablets are weighed individually and an compendia weight is taken, the average weight is obtained by dividing the compendia weight by 20, now the average weight is compared to the individual weight of the tablet,

For a tablet to pass the test not more than 2 tablets should lie out of the specified percentage and if no tablet differs by more than two times the percentage limit.

Average weight

Maximum percentage difference allowed

WETTING TIME (Gohel et al., 2004)

A circular tissue paper of 10cm diameter were placed in a Petri dish having an internal diameter of 10 cm. 10 ml of water containing methylene blue (10% w/w) was added to the Petri dish. The tablet was carefully placed in the centre of the Petri dish and the time taken for the water to reach the upper surface of the tablets was known as wetting time.

7) DISINTEGRATION:

Disintegration is the first physical change observed for a drug when it enters into the body, thus to see simulate the disintegration of the tablet in the body the disintegration test is performed.

As per USP the disintegration apparatus consist of 6 glass tubes with a 10 number mesh at the bottom, each tube is 3 inch long.

This arrangement of 6 tubes is placed in a medium simulated to the disintegration environment. Which is maintained at 37oc +/- 2oc, in 1 liter vessel.

This system is made to move up and down through a distance of 5 to 6 cm at a frequency of 28 to 32 cycles per minute.

The disintegration time of the tablet is compared with the values in the monograph.

DRUG CONTENT (IP, 2007)

20 tablets were weighed and powdered. A quantity of powder containing 0.15 g of Paracetamol was added to 0.1 M NaOH, diluted with 100 ml of water. It was shaken for 15 minutes and sufficient water was added to produce 200 ml. 10 ml of the filtrate was diluted to 100 ml with water. Then 10 ml of the resulting solution was added to 10 ml of 0.1 M NaOH, finally diluted to 100 ml with water. The absorbance was measured at maximum of 257 nm. Calculate the content of C5H9N02 taking 715 as the value of A (1%, 1cm) at maximum at 257 nm.

8) DISSOLUTION:

Tablet dissolution: Disintegration time determination is a useful tool for production control, but disintegration of a tablet does not imply that the drug has dissolved. A tablet can have a rapid disintegration time yet be biologically unavailable. The dissolution rate of the drug from the primary particles of the tablet is the important factor in drug absorption and for many formulations is the rate-limiting step. Therefore, a dissolution time is more indicative of the availability of a drug from a tablet than the disintegration test. Even though this is an important parameter to measure, most pharmacies do not have the equipment needed to conduct these kinds of tests.

The rate and extent of drug release form the tablet is estimated by dissolution test

Different types of apparatus are used to study the dissolution test of the tablet. As per IP apparatus I (paddle) and apparatus II(basket) are used. called basket dissolution apparatus and paddle dissolution apparatus

But as per USP dissolution apparatus used are

USP 30 classification

i. Rotating Basket (Ph.Eur./BP/JP)

ii. Paddle (Ph.Eur./BP/JP)

iii. Reciprocating Cylinder (Ph.Eur.)

iv. Flow Through Cell (Ph.Eur./BP/JP)

v. Paddle Over Disk (Ph.Eur.)

vi. Rotating Cylinder (Ph.Eur.)

vii. Reciprocating Holder

  1. DISSOLUTION KINETICS (Higuchi WI, 1962)

Method used to compare dissolution data is:

  • Model Dependent Methods (zero order, first order, Higuchi and Korsmeyer’s- Peppas).

Drug release kinetics

Drug release kinetics was studied from the datas obtained from in-vitro drug release studies which were plotted in various kinetics models: Zero order (equation 1) as Cumulative percentage of drug released against Time, First order (equation 2) as Log cumulative percentage of drug unreleased against Time, and Higuchi model (equation 3) as Cumulative percentage of drug released against Square root of time.

C = K0 t                                    (equation 1)

where       K0 indicates zero order rate constant expressed as                            concentration per time and t indicates the time in                                   hours.

A graph of concentration against time gives a straight line with a slope equal to K0 and intercept the origin of the axis.

log C = log C0 – K t/2.303                              (equation 2)

where         C0 be the initial concentration of drug,

K be the first order constant, and t is the time.

Q = K t1/2                                                                        (equation 3)

where        K indicates the constant of the system, t indicates the   time in hours.

Drug release were plotted in Korsmeyer equation (equation 4) as Log cumulative percentage of drug released against Log time, and the exponent was calculated from  the slope of the straight line.

Mt / Mα =  K tn                                                             (equation 4)

where          Mt / Mα is the fraction of solute release, t is the release time,  K is the kinetic constant

The dissolution time and rate is compared to the values mentioned in the monograph.

In vitro disintegration test

Disintegration is defined as the process of breakdown of tablet into small particles. Disintegration time of a tablet is determined by using disintegration test apparatus as per IP specifications. Place each tablet in each 6 tubes of the disintegration apparatus a then add a disc to each tube containing 6.8 pH phosphate buffer. The temperature of the buffer should maintain at 37 ± 2°C and run the apparatus raised and lowered for 30 cycles per minute. Note down the time taken for the complete disintegration of the tablet without any remitants .

References
1. J. S. Swarbrick, Encyclopedia of Pharmaceutical Technology, Third dition – 6 Volume Set,
Taylor & Francis, 2006.

Lachman et al., 1990