The document discusses aseptic technique, which aims to prevent microbial contamination during pharmaceutical production. It outlines potential sources of contamination including the atmosphere, human breath/hands/clothing, and working surfaces. The design of an aseptic laboratory is also described, emphasizing its isolation from non-pharmaceutical areas, size for efficient work, windows for visibility but not opening, airlock entry, and smooth/impervious flooring, wall, ceiling and bench materials like terrazzo, linoleum and stainless steel that are easy to clean.
Aseptic techniques are methods used to prevent microorganisms from contaminating parenteral products during preparation and testing. They are important to reduce post-procedure infections and protect healthcare workers. Good aseptic technique requires understanding potential contamination sources like the atmosphere, hands, coughing, hair, and unsterile equipment. GMP requirements for manufacturing sterile products include clean area classifications, building specifications, sterilizing equipment, filtration, and following guidelines for environmental factors and water systems. Strict adherence to aseptic techniques and GMPs is necessary to avoid contamination and ensure high quality sterile pharmaceutical products.
The document provides guidance on basic cGMPs (current Good Manufacturing Practices) for pharmaceutical manufacturing. It discusses requirements for quality management, facilities and equipment, raw material control, production processes, laboratories, warehousing, documentation, gowning procedures, and sterile drug production. The key points are that cGMPs ensure minimum standards for quality are met, personnel must be properly trained and attired to prevent contamination, facilities and equipment must be cleaned and maintained, raw materials must be tested and stored securely, and processes must be documented thoroughly.
“Gowning” is a set of garments worn while in a clean room or other controlled environment. The
level of gowning required is a function of the product or process, and its cleanliness
requirements.
Gowning can cover some or all of the following:
Head / hair
Beard / mustache
Face
Torso / Upper body
Legs / pants
Feet / shoes
Hands
This is the 1st part of our "All about cleanrooms". This presentation will take you through the history of cleanrooms, types and applications of cleanrooms.
Gowning refers to wearing special garments to control particulate contamination in cleanrooms. Correct gowning procedures are important because contamination can be invisible. Operators must be well-trained in gowning to avoid introducing contamination. Gowning includes showering and hygiene at home, changing at work while avoiding contact with floors, and wearing multiple layered garments specific to each cleanroom grade that fully cover the body and shed no particles. Proper gowning allows entry to production areas while avoiding contamination.
equipment for large scale paretral and quality controlSatyam Kumar
This document summarizes equipment and quality control procedures for the large-scale manufacture of parenteral products. It describes storage, washing, drying, filling and sealing equipment needed for manufacturing areas and aseptic rooms. Quality control includes leak testing, clarity testing, pyrogen testing using rabbit tests or LAL assays, and sterility testing to check for microorganisms. HEPA filters and laminar flow work stations are used to maintain sterile conditions.
This document discusses key considerations for the aseptic manufacturing of sterile pharmaceutical products. It covers classification of clean areas, environmental monitoring, preparation and filtration of solutions, personnel requirements, equipment sterilization, and validation of aseptic processes. The main objectives are to prevent microbial contamination and maintain sterility throughout manufacturing.
This document discusses microbial contamination control in parenteral manufacturing. It outlines various layers of protection used, including terminal sterilization techniques like autoclaving. It also discusses aseptic processing and sources of contamination control strategies during aseptic manufacture. Other topics covered include blow-fill-seal technology, issues in sterilization by filtration, sterile prefilled syringes, process validation, hazard analysis and critical control points. Key sterilization techniques and the selection of appropriate test organisms to validate these processes are also summarized.
Aseptic techniques are methods used to prevent microorganisms from contaminating parenteral products during preparation and testing. They are important to reduce post-procedure infections and protect healthcare workers. Good aseptic technique requires understanding potential contamination sources like the atmosphere, hands, coughing, hair, and unsterile equipment. GMP requirements for manufacturing sterile products include clean area classifications, building specifications, sterilizing equipment, filtration, and following guidelines for environmental factors and water systems. Strict adherence to aseptic techniques and GMPs is necessary to avoid contamination and ensure high quality sterile pharmaceutical products.
The document provides guidance on basic cGMPs (current Good Manufacturing Practices) for pharmaceutical manufacturing. It discusses requirements for quality management, facilities and equipment, raw material control, production processes, laboratories, warehousing, documentation, gowning procedures, and sterile drug production. The key points are that cGMPs ensure minimum standards for quality are met, personnel must be properly trained and attired to prevent contamination, facilities and equipment must be cleaned and maintained, raw materials must be tested and stored securely, and processes must be documented thoroughly.
“Gowning” is a set of garments worn while in a clean room or other controlled environment. The
level of gowning required is a function of the product or process, and its cleanliness
requirements.
Gowning can cover some or all of the following:
Head / hair
Beard / mustache
Face
Torso / Upper body
Legs / pants
Feet / shoes
Hands
This is the 1st part of our "All about cleanrooms". This presentation will take you through the history of cleanrooms, types and applications of cleanrooms.
Gowning refers to wearing special garments to control particulate contamination in cleanrooms. Correct gowning procedures are important because contamination can be invisible. Operators must be well-trained in gowning to avoid introducing contamination. Gowning includes showering and hygiene at home, changing at work while avoiding contact with floors, and wearing multiple layered garments specific to each cleanroom grade that fully cover the body and shed no particles. Proper gowning allows entry to production areas while avoiding contamination.
equipment for large scale paretral and quality controlSatyam Kumar
This document summarizes equipment and quality control procedures for the large-scale manufacture of parenteral products. It describes storage, washing, drying, filling and sealing equipment needed for manufacturing areas and aseptic rooms. Quality control includes leak testing, clarity testing, pyrogen testing using rabbit tests or LAL assays, and sterility testing to check for microorganisms. HEPA filters and laminar flow work stations are used to maintain sterile conditions.
This document discusses key considerations for the aseptic manufacturing of sterile pharmaceutical products. It covers classification of clean areas, environmental monitoring, preparation and filtration of solutions, personnel requirements, equipment sterilization, and validation of aseptic processes. The main objectives are to prevent microbial contamination and maintain sterility throughout manufacturing.
This document discusses microbial contamination control in parenteral manufacturing. It outlines various layers of protection used, including terminal sterilization techniques like autoclaving. It also discusses aseptic processing and sources of contamination control strategies during aseptic manufacture. Other topics covered include blow-fill-seal technology, issues in sterilization by filtration, sterile prefilled syringes, process validation, hazard analysis and critical control points. Key sterilization techniques and the selection of appropriate test organisms to validate these processes are also summarized.
This document discusses clean rooms and aseptic areas. It defines clean rooms as rooms with controlled particulate and microbial contamination to reduce introduction of contaminants. It discusses sources of contamination including external sources like HVAC systems and internal sources like people, equipment and materials. It describes different air flow systems like conventional and laminar air flow. Key factors for clean room design and operation are outlined such as air filtration, temperature/humidity control, clothing, cleaning and monitoring.
This document discusses parenteral products and water for injection (WFI). It provides details on:
1) What defines a parenteral product and reasons they are unique dosage forms.
2) The manufacturing process for parenteral products including procurement, processing, packaging, and quality control.
3) Key factors for WFI production including distillation units, storage and distribution, and validation to ensure quality standards.
Filtration is a separation technique used to separate solids from fluids by passing a mixture through a porous medium. There are different types of filtration based on the direction of fluid flow and type of filter medium used. The principle of filtration relies on the pores of the filter medium being smaller than the particles to be separated, with the solid particles getting trapped on the surface of the filter medium due to pressure differences. Filtration has various applications including in laboratories, effluent treatment plants, sterilizing drugs, and filtering waste from blood. It also occurs naturally in the lungs and kidneys.
This document provides information about the production of pharmaceutical extracts and tinctures. It defines different types of extracts such as liquid extracts, soft extracts, and dry extracts. It describes the production process for extracts, including using suitable solvents like ethanol to extract herbal drugs or animal matter. It also provides labeling requirements for extracts. The document then discusses the production of tinctures, including definitions and methods like maceration and percolation. It provides testing and labeling guidelines for tinctures.
This document provides information on filtration equipment and processes. It defines filtration and clarification, and describes the key components of filtration including the slurry, filter medium, filter cake, and filtrate. It explains the basic process of filtration using pressure differences and discusses various filtration applications. Different filtration mechanisms, types including surface and depth filtration, and factors influencing filtration are outlined. Finally, the document focuses on plate and frame filter presses, describing their construction, working principles for both filtration and washing operations, and some special provisions and uses.
Equipments used for semi solid dosage formAli Hamza
This document discusses equipment used for manufacturing semi-solid dosage forms such as ointments, pastes, gels and jellies. It describes mills such as fluidized energy mills and roller mills that are used to mill ingredients. It also mentions mixers that are used for mixing, emulsification and deaeration in the production of ointments and creams. The document provides details on the manufacturing process and requirements for packaging and labeling of semi-solid dosage forms.
Gowning in the pharmaceutical industry Jony Mallik
Gowning procedures in the pharmaceutical industry are important to prevent contamination. Special garments must be worn to enter controlled manufacturing areas. There are multiple change rooms with increasing restrictions. The first change room provides basic protective clothing for warehouse and sampling areas. The primary change room has a stricter protocol for manufacturing areas, including lint-free attire, shoe covers, and hand washing. Uniform colors are assigned by department to identify personnel. Strict hygiene practices are required both at home and at the facility for anyone entering production zones.
The document discusses cleanroom protocols and procedures. It defines cleanrooms and their importance for minimizing contamination, especially in semiconductor manufacturing. It outlines cleanroom classifications, air filtration systems, environmental controls, and guidelines for cleaning, materials selection, and user behavior. Strict adherence to cleanroom protocols by all users is emphasized as essential for maintaining the clean environment.
To maintain the desired SAL at the plant is task which demands great care and control over Man, Machine & Method. This summarize work will definitely help you as hand note.
This document discusses various types of distillation processes including simple distillation, fractional distillation, steam distillation, vacuum distillation, and vacuum still distillation. It provides definitions and explanations of the principles, apparatuses, and working processes for each type. Applications are also described for separating and purifying various substances using these distillation techniques.
The document discusses evaluation and stability studies of tablets. It provides details on common tablet tests performed during evaluation including general appearance, hardness, friability, weight variation, disintegration, and dissolution. It also discusses factors affecting drug stability and the various types of stability that must be considered, including chemical, physical, microbiological, therapeutic, and toxicological stability. Guidelines for stability testing from ICH, USP, FDA and other organizations are also summarized regarding testing conditions, frequency, and requirements for re-testing tablets after registration.
Friable: “ A friable substance is any substance that can be reduced to finer particles by the action of a small pressure or friction, such as rubbing or inadvertently brushing up against the substance”.
Friability test: Defined as the % of weight loss by tablets due to mechanical action during the test. Tablets are weighing before & after testing & friability is expressed as a percentage loss on pre-test tablet weight. & Friability test is done to check the ability of the compressed tablet to avoid fracture & breaking during the transport.
This testing involves repeatedly dropping a sample of tablets over a fixed time, using a rotating wheel with a baffle. The result is inspected for broken tablets, and the percentage of tablet mass lost through chipping.
If the average weight of the tablet is 0.65gm or less. Take 10 times of the whole weight i.e., 6.5 gm
2. Carefully deducts the tablets & weight required numbers of tablets.
Initial weight = 6.536gm
3. Set the Time duration for 4min
4. Set number of counts to 100
5. Make sure the drum is cleaned with no contaminates ,
add the initial weighted tables carefully & close the lid
6. Click Start button
Drum diameter : 283 -291mm
Depth: 36-40mm
Inner radius of the curve projection : 75.5mm – 85.5mm
Outer diameter of the central ring : 24.5mm – 25.5mm
Rotation Speed : 25 +/_ 1 cycle
Time Set: 4 min
After 4min automatically it stops ,
7. Take out the tablets & take out the dust from the tablets using brush /crumps
8. Take the After weight of the tablets
Total weight of after rotation= 6.443gm
Interpretation :
Value of friability should not be more than 1% for most of tablets.
If the value of friability for the first is greater than 1%, then repeat the test twice & mean of three values is taken.
If the mean value of three tests is less than 1% tablets passes the friability test,
otherwise tablet fails the test.
If the tablets are broken , chipped or cracked during the test, the tablets fails the friability test.
By ArcImBioCLinica (AIBC)
Machines Used In the Pharmaceutical IndustrySaintyco Group
The product ranges comprise capsules, tablets, liquid medicines, injections, powders and several others. These different types of items are packed employing different types of filling machines, for example capsules packed using capsule filling machine.
This document provides guidelines for fumigating operating theaters using formaldehyde vapor to disinfect the space. It describes the process which includes calculating the amount of formaldehyde needed based on room size, heating the solution to generate vapor, sealing the room for 12-24 hours, and then neutralizing the fumes with ammonia before re-occupying the space. It also provides guidance on microbiological monitoring before and after fumigation to check the effectiveness of the process and guidelines for acceptable colony counts.
Application of filtration process in pharmaceuticalFarzana Sultana
This document discusses various filtration processes used in the pharmaceutical industry. It describes how filtration is used to separate solids and liquids and the importance of closed filtration systems to protect workers. It also discusses different types of air and gas filtration like membrane filters and HEPA filters. It covers adsorptive depth filtration using activated carbon and filtration of solvents and bulk chemicals. The document emphasizes the need for sterilizing grade filtration of liquids, gases and utilities like nitrogen and water used in pharmaceutical production processes.
This document discusses aseptic technique for central venous catheter care. It defines asepsis and aseptic technique, and describes the evidence base for various aspects of catheter care. Key evidence-based elements that should be included in any standardized technique are hand decontamination with alcohol, disinfecting catheter hubs with chlorhexidine for at least 15 seconds, using prefilled syringes, flushing with saline, and protecting ports with isopropyl alcohol discs. Outcomes like infection rates can assess the efficacy of techniques, but definitions and diagnostic methods vary, making direct comparisons difficult. Standardizing catheter care procedures according to evidence-based principles could help improve outcomes.
Aseptic Technique
The media on which you culture desirable microorganisms will readily grow undesirable contaminants, especially molds and other types of fungus, and bacteria from your skin and hair. It is therefore essential that you protect your cultures from contamination from airborne spores and living microorganisms, surface contaminants that may be on your instruments, and from skin contact.
Bacteria and other contaminants cannot fly. Nearly all forms of contamination are carried on microscopic dust particles that make their way onto sterile surfaces when they are carelessly handled. One exception is insect contamination, such as by ants for fruit flies. Fruit flies are a particular nuisance because they can crawl under the lids of agar plates and lay eggs. You would think that people doing genetics research would have developed a model by now that can't fly into other peoples' experiments!
A contaminated culture can often be rescued, however there is always the risk that you will re-isolate the wrong microorganism. Besides, you don't have that kind of time to waste. Exercise extreme care to keep your cultures pure.
This document discusses clean rooms and aseptic areas. It defines clean rooms as rooms with controlled particulate and microbial contamination to reduce introduction of contaminants. It discusses sources of contamination including external sources like HVAC systems and internal sources like people, equipment and materials. It describes different air flow systems like conventional and laminar air flow. Key factors for clean room design and operation are outlined such as air filtration, temperature/humidity control, clothing, cleaning and monitoring.
This document discusses parenteral products and water for injection (WFI). It provides details on:
1) What defines a parenteral product and reasons they are unique dosage forms.
2) The manufacturing process for parenteral products including procurement, processing, packaging, and quality control.
3) Key factors for WFI production including distillation units, storage and distribution, and validation to ensure quality standards.
Filtration is a separation technique used to separate solids from fluids by passing a mixture through a porous medium. There are different types of filtration based on the direction of fluid flow and type of filter medium used. The principle of filtration relies on the pores of the filter medium being smaller than the particles to be separated, with the solid particles getting trapped on the surface of the filter medium due to pressure differences. Filtration has various applications including in laboratories, effluent treatment plants, sterilizing drugs, and filtering waste from blood. It also occurs naturally in the lungs and kidneys.
This document provides information about the production of pharmaceutical extracts and tinctures. It defines different types of extracts such as liquid extracts, soft extracts, and dry extracts. It describes the production process for extracts, including using suitable solvents like ethanol to extract herbal drugs or animal matter. It also provides labeling requirements for extracts. The document then discusses the production of tinctures, including definitions and methods like maceration and percolation. It provides testing and labeling guidelines for tinctures.
This document provides information on filtration equipment and processes. It defines filtration and clarification, and describes the key components of filtration including the slurry, filter medium, filter cake, and filtrate. It explains the basic process of filtration using pressure differences and discusses various filtration applications. Different filtration mechanisms, types including surface and depth filtration, and factors influencing filtration are outlined. Finally, the document focuses on plate and frame filter presses, describing their construction, working principles for both filtration and washing operations, and some special provisions and uses.
Equipments used for semi solid dosage formAli Hamza
This document discusses equipment used for manufacturing semi-solid dosage forms such as ointments, pastes, gels and jellies. It describes mills such as fluidized energy mills and roller mills that are used to mill ingredients. It also mentions mixers that are used for mixing, emulsification and deaeration in the production of ointments and creams. The document provides details on the manufacturing process and requirements for packaging and labeling of semi-solid dosage forms.
Gowning in the pharmaceutical industry Jony Mallik
Gowning procedures in the pharmaceutical industry are important to prevent contamination. Special garments must be worn to enter controlled manufacturing areas. There are multiple change rooms with increasing restrictions. The first change room provides basic protective clothing for warehouse and sampling areas. The primary change room has a stricter protocol for manufacturing areas, including lint-free attire, shoe covers, and hand washing. Uniform colors are assigned by department to identify personnel. Strict hygiene practices are required both at home and at the facility for anyone entering production zones.
The document discusses cleanroom protocols and procedures. It defines cleanrooms and their importance for minimizing contamination, especially in semiconductor manufacturing. It outlines cleanroom classifications, air filtration systems, environmental controls, and guidelines for cleaning, materials selection, and user behavior. Strict adherence to cleanroom protocols by all users is emphasized as essential for maintaining the clean environment.
To maintain the desired SAL at the plant is task which demands great care and control over Man, Machine & Method. This summarize work will definitely help you as hand note.
This document discusses various types of distillation processes including simple distillation, fractional distillation, steam distillation, vacuum distillation, and vacuum still distillation. It provides definitions and explanations of the principles, apparatuses, and working processes for each type. Applications are also described for separating and purifying various substances using these distillation techniques.
The document discusses evaluation and stability studies of tablets. It provides details on common tablet tests performed during evaluation including general appearance, hardness, friability, weight variation, disintegration, and dissolution. It also discusses factors affecting drug stability and the various types of stability that must be considered, including chemical, physical, microbiological, therapeutic, and toxicological stability. Guidelines for stability testing from ICH, USP, FDA and other organizations are also summarized regarding testing conditions, frequency, and requirements for re-testing tablets after registration.
Friable: “ A friable substance is any substance that can be reduced to finer particles by the action of a small pressure or friction, such as rubbing or inadvertently brushing up against the substance”.
Friability test: Defined as the % of weight loss by tablets due to mechanical action during the test. Tablets are weighing before & after testing & friability is expressed as a percentage loss on pre-test tablet weight. & Friability test is done to check the ability of the compressed tablet to avoid fracture & breaking during the transport.
This testing involves repeatedly dropping a sample of tablets over a fixed time, using a rotating wheel with a baffle. The result is inspected for broken tablets, and the percentage of tablet mass lost through chipping.
If the average weight of the tablet is 0.65gm or less. Take 10 times of the whole weight i.e., 6.5 gm
2. Carefully deducts the tablets & weight required numbers of tablets.
Initial weight = 6.536gm
3. Set the Time duration for 4min
4. Set number of counts to 100
5. Make sure the drum is cleaned with no contaminates ,
add the initial weighted tables carefully & close the lid
6. Click Start button
Drum diameter : 283 -291mm
Depth: 36-40mm
Inner radius of the curve projection : 75.5mm – 85.5mm
Outer diameter of the central ring : 24.5mm – 25.5mm
Rotation Speed : 25 +/_ 1 cycle
Time Set: 4 min
After 4min automatically it stops ,
7. Take out the tablets & take out the dust from the tablets using brush /crumps
8. Take the After weight of the tablets
Total weight of after rotation= 6.443gm
Interpretation :
Value of friability should not be more than 1% for most of tablets.
If the value of friability for the first is greater than 1%, then repeat the test twice & mean of three values is taken.
If the mean value of three tests is less than 1% tablets passes the friability test,
otherwise tablet fails the test.
If the tablets are broken , chipped or cracked during the test, the tablets fails the friability test.
By ArcImBioCLinica (AIBC)
Machines Used In the Pharmaceutical IndustrySaintyco Group
The product ranges comprise capsules, tablets, liquid medicines, injections, powders and several others. These different types of items are packed employing different types of filling machines, for example capsules packed using capsule filling machine.
This document provides guidelines for fumigating operating theaters using formaldehyde vapor to disinfect the space. It describes the process which includes calculating the amount of formaldehyde needed based on room size, heating the solution to generate vapor, sealing the room for 12-24 hours, and then neutralizing the fumes with ammonia before re-occupying the space. It also provides guidance on microbiological monitoring before and after fumigation to check the effectiveness of the process and guidelines for acceptable colony counts.
Application of filtration process in pharmaceuticalFarzana Sultana
This document discusses various filtration processes used in the pharmaceutical industry. It describes how filtration is used to separate solids and liquids and the importance of closed filtration systems to protect workers. It also discusses different types of air and gas filtration like membrane filters and HEPA filters. It covers adsorptive depth filtration using activated carbon and filtration of solvents and bulk chemicals. The document emphasizes the need for sterilizing grade filtration of liquids, gases and utilities like nitrogen and water used in pharmaceutical production processes.
This document discusses aseptic technique for central venous catheter care. It defines asepsis and aseptic technique, and describes the evidence base for various aspects of catheter care. Key evidence-based elements that should be included in any standardized technique are hand decontamination with alcohol, disinfecting catheter hubs with chlorhexidine for at least 15 seconds, using prefilled syringes, flushing with saline, and protecting ports with isopropyl alcohol discs. Outcomes like infection rates can assess the efficacy of techniques, but definitions and diagnostic methods vary, making direct comparisons difficult. Standardizing catheter care procedures according to evidence-based principles could help improve outcomes.
Aseptic Technique
The media on which you culture desirable microorganisms will readily grow undesirable contaminants, especially molds and other types of fungus, and bacteria from your skin and hair. It is therefore essential that you protect your cultures from contamination from airborne spores and living microorganisms, surface contaminants that may be on your instruments, and from skin contact.
Bacteria and other contaminants cannot fly. Nearly all forms of contamination are carried on microscopic dust particles that make their way onto sterile surfaces when they are carelessly handled. One exception is insect contamination, such as by ants for fruit flies. Fruit flies are a particular nuisance because they can crawl under the lids of agar plates and lay eggs. You would think that people doing genetics research would have developed a model by now that can't fly into other peoples' experiments!
A contaminated culture can often be rescued, however there is always the risk that you will re-isolate the wrong microorganism. Besides, you don't have that kind of time to waste. Exercise extreme care to keep your cultures pure.
Aseptic technique refers to procedures performed under sterile conditions to prevent microbial contamination. It is important in microbiology laboratories and medical settings to prevent contamination of microorganisms being worked with as well as the environment. Sources of contamination include the atmosphere, hands, clothing, and equipment. Sterilization, disinfection, and antisepsis are used to eliminate or inhibit microbes. General principles of aseptic technique include disinfecting work areas, flaming inoculating loops before and after transfers between containers, and working quickly while containers remain capped. Following aseptic technique helps prevent contamination during microbiology experiments and medical procedures.
The document discusses the requirements and layout for producing sterile parenterals. It describes the different sections needed - cleanup, compounding, aseptic, quarantine, and packing/labeling. Specific requirements for the aseptic area are outlined, including environmental controls like particle counting, slit to agar sampling, and Rodac plates to evaluate air quality. Floors, walls, and benches must be smooth, impervious, and easy to clean. Proper ventilation and filtration of air is essential to maintain sterility. Sources of contamination and prevention methods are also covered.
This document provides information about aseptic techniques for intravenous (IV) preparation:
1) Aseptic technique involves procedures to keep sterile products contamination-free. IV is the most common parenteral route of drug administration today.
2) Risks of IV therapy include infection, air embolism, bleeding, allergic reactions, incompatibilities, extravasation, particulate contamination, and phlebitis.
3) Sterile areas and laminar flow hoods are used to maintain sterile conditions during IV preparation, with strict protocols for equipment placement, personnel movement, and cleaning.
A sterility test assesses whether a pharmaceutical product is free from microorganisms. It involves incubating samples of the product in nutrient media. There are three main methods for conducting sterility tests: direct inoculation into media, membrane filtration, and adding concentrated media to products in their original containers. Two common media used are fluid thioglycollate medium and soybean-casein digest medium. Controls and appropriate sampling methods are necessary to accurately determine if a batch meets sterility requirements.
This document discusses microbiology activities related to sterility assurance for pharmaceutical products. It outlines the microbiological testing done on raw materials, processes, water systems, environments and finished products. This includes bioburden testing, pathogen testing, endotoxin testing, and sterility testing. It also discusses environmental monitoring programs for sterile facilities and aseptic filling areas. Key requirements outlined include pre-filtration bioburden limits, media fill qualifications, aseptic process simulations, and staff performance monitoring. Recent issues with increased out of limit environmental monitoring results are also summarized.
Using Aseptic Technique to identify the effect of antibiotics on 3 strains of...06426345
The document provides instructions for learning aseptic technique to safely plate bacterial cultures, including organizing work areas sterilely, opening culture tubes without contaminating surfaces, and plating bacteria without damaging agar. Success criteria cover sterile technique skills like maintaining sterility when accessing cultures and plating bacteria without agar damage. Background information defines aseptic technique as procedures under sterile conditions to prevent infection spread.
Contamination risks in aseptic operations come primarily from people and air. Environmental monitoring programs assess these risks by detecting airborne particles and microorganisms. Risk assessment tools help identify critical control points and establish action levels to minimize contamination risks. The goal is controlling contamination sources to ultimately ensure patient safety.
This document outlines guidelines for maintaining aseptic technique during medical procedures. It describes aseptic technique as a method to prevent wound contamination and infection by ensuring only sterile equipment and fluids are used. The guidelines specify steps like cleaning hands and surfaces, checking sterile products, and opening sterile packs without contamination. It emphasizes using one hand for sterile materials and the other for contaminated items near the patient. The waste bag should be positioned away from the sterile field to avoid cross-contamination when discarding used materials.
This document discusses aseptic processing and packaging. Aseptic processing involves sterilizing products, packaging materials, and facilities to prevent contamination. It results in shelf-stable products sealed in sterile packaging without refrigeration. The process includes UHT sterilization, filling in sterile environments, and hermetically sealed packages. Hyosung built Korea's first complete aseptic production facility with an annual capacity of 315 million bottles and state-of-the-art technology from preforms to filling. Aseptic packages provide benefits of portability, food safety from bacteria, and retaining more nutrients compared to canning.
An introduction to the international cleanroom standard ISO 14644 and the 2015 revisions to Parts 1 and 2. The focus is on particulate and contamination control.
Allium sativum (garlic) has potential as a biological control agent. The document reviews the biology of garlic and studies on its ability to control pests and pathogens. Garlic extracts have shown to inhibit fungal growth and reduce disease severity in tomatoes and downy mildew of cucumbers. Crude garlic extract provided over 90% control of sorghum ergot under greenhouse and field conditions. Results indicate garlic extracts are promising as natural, effective and environmentally friendly alternatives to synthetic pesticides for controlling agricultural diseases and insects.
This document presents information about anti-bacterial activity screening techniques. It discusses bacteriostatic agents, which prevent bacterial growth without killing bacteria, and assessments of bacteriostatic activity including serial dilution methods in fluid and solid media as well as cup plate and gradient plate methods. It also discusses bactericidal agents, which kill bacteria, and assessments of bactericidal activity including end-point or extinction time methods such as the Phenol coefficient test and varying the concentration or contact time of disinfectants. The document was presented to Dr. Chaluvaraju KC by Mr. Pradeep on the topic of anti-bacterial activity and screening techniques.
The document discusses various methods for testing the efficacy of disinfectants, including:
1. Koch's method, which tests the ability of a disinfectant to kill Bacillus anthraces spores.
2. Rideal Walker and Chick-Martin tests, which determine the phenol coefficient of a disinfectant by comparing its bactericidal effects to phenol under clean and dirty conditions.
3. In-use and capacity use dilution tests assess the ability of a disinfectant to kill microbes when diluted in conditions mimicking actual use over time in the presence of organic matter.
4. No single test can reliably determine a disinfectant's efficacy
Microencapsulation is a process where core materials are surrounded by a continuous film of polymeric material to form microparticles or microcapsules between 3-800μm in size. There are various techniques to microencapsulate such as spray drying, pan coating, and polymerization. Microencapsulation can increase bioavailability, alter drug release, and provide targeted drug delivery. Evaluation of the microcapsules involves measuring yield percentage, particle size, drug content, encapsulation efficiency, and in vitro drug release.
Sterile technique is essential in surgical settings. Key aspects of maintaining sterility include properly scrubbing and gloving personnel, ensuring sterile packaging and items are handled appropriately, defining boundaries of the sterile field, and having clear roles and procedures for scrubbed and unscrubbed team members. Any break in sterile technique must be addressed immediately to minimize risk to the patient. Professional organizations like AORN provide guidelines for standard practices to establish and maintain a sterile surgical field.
This presentation is compiled by “ Drug Regulations” from freely available resources like the FDA on the World wide web.
“Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals.
The document discusses key concepts related to asepsis and infection control in healthcare settings. It defines various medical and microbiological terminology and outlines the basic principles of medical and surgical asepsis. Maintaining asepsis involves knowing what is clean, dirty and sterile and keeping these conditions separate. Standard precautions that all healthcare workers should follow to minimize exposure and transmission of infections are also described, including hand hygiene, use of personal protective equipment, safe disposal of sharps and contaminated waste.
This document discusses sterility testing methodology and interpretation. It describes the principles, objectives, culture media, control tests, and methods used for sterility testing. The main methods discussed are membrane filtration (Method A) and direct inoculation (Method B). It provides details on the types of media used, how the tests are performed, and considerations for interpreting the results.
Design of An Aseptic Area and Clean Area ClassificationManusinghai2
Aseptic pharmaceutical manufacturing is most commonly used for most vaccines, biologics, other injectable drugs, cancer drugs, ear drops, nasal sprays, and eye drops. Also known as fill-finish manufacturing, aseptic manufacturing minimizes the risk of introducing bacteria and contaminants into the body while administering medication.
Aseptic processing of pharmaceuticals involves virtually every step of the manufacturing process, from the formulation to the filling, inspection, labeling, and packaging. Skilled manufacturing partners are needed for aseptic manufacturing, as errors can cause production delays, health risks, and product loss.
Current Good Manufacturing Process (cGMP) standards from the FDA stipulate that aseptic pharmaceutical manufacturers must:
• Have a separate, classified clean area
• Ensure that air is filtered and properly circulated
• Sterilize and maintain all containers and closures
• Have personnel that are dressed in sterile clothes, adequately trained, and closely monitored
• Set time limits for different steps of the manufacturing process
• Simulate and record the manufacturing process
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with "Aseptic requirements for parenteral products".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
The Indian Dental Academy is the Leader in continuing dental education , training dentists in all aspects of dentistry and
offering a wide range of dental certified courses in different formats.for more details please visit
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The document describes the process for preparing parenteral products. It involves:
1. Cleaning and sterilizing all equipment and containers using methods like steam, dry heat, or filtration.
2. Compounding the product carefully under clean conditions while filtering and filling containers.
3. Sealing the containers securely and testing the finished product through quality control processes like sterility testing to ensure safety.
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1. ASEPTIC TECHNIQUE
Topics:
• Sources of Contamination
• Design of an asepsis Laboratory
• Cleaning methods of asepsis laboratory
• Clothing
• Asepsis room ventilation
2. What is the Aim of Aseptic Technique?
• To prevent the access of micro-organisms during the preparation
and testing of pharmaceutical products.
When is Aseptic Technique unnecessary?
If the last two stages in the processing of a sterile product are –
• Packing in a container and sealing to prevent contamination after
sterilization, followed by
• Sterilization by one of the three official heat sterilization
processes –
– Dry heat
– Autoclaving or
– Heating with a bactericide
3. A terminal heat treatment is not possible
for several classes of product:
(a) Thermolabile Soluble Substances, Stable in Solution.
– can be filtered through a bacteria- proof filter
– aseptic technique is required to prevent contamination of
the filtrate during collection and while it is being packed
and sealed in the final containers.
– Eg. Thiamine Hydrochloride Injection.
(b) Thermolabile Soluble Substances, Unstable in Solution.
– They must be dissolved aseptically in a sterile solvent just
before use,
– Eg. Chorionic Gonadotrophin Injection.
4. A terminal heat treatment is not possible for several
classes of product (Contd.):
(c) Thermolabile Suspensions, Stable in the Vehicle,
– Eg. Propyliodone and Propyliodone Oily Injections.
(d) Thermolabile Powders that require Dilution with Other Powders,
– Eg. antibiotic dusting powders.
(e) Thermolabile Powders that require Incorporation in a Semi-solid base,
– Eg. the eye ointments of the British Pharmacopoeia.
• Filtration is impossible in the last three cases and, therefore,
• The medicament must be mixed with the appropriate sterile vehicle
aseptically.
5. SOURCES OF CONTAMINATION
Satisfactory rules for good aseptic technique can only
be devised if the possible sources of contamination
are fully appreciated.
1. The Atmosphere
– The atmosphere has no flora of its own - cannot support
the growth of micro-organisms.
– a shaft of light in a darkened room demonstrates heavy
contamination with particles.
– micro-organisms are associated with many of these.
6. TYPES OF CONTAMINATION
(c)Dust
Outdoors:
• dust particles in outside air come from the soil
may carry soil bacteria.
• these are saprophytes and
• include cocci (mainly species of Sarcina and
Micrococcus) and
• sporing rods (particularly Bacillus spp.)
• pathogenic anaerobic sporing rods (e.g. Clostridium
tetani and Clostridium welchii) - quite common.
7. Indoors
• the dust stirred up by cleaning operations
sometimes contains resistant pathogens.
• Eg. Staphylococcus aureus, Haemolytic
streptococci, Mycobacterium tuberculosis and
intestinal bacteria.
8. (b) Droplets
• droplets are expelled from the respiratory tract by coughing
and sneezing
• contain organisms from the nose, mouth, throat and lungs.
• healthy carriers often distribute Staphylococcus aureus and
Beta haemolytic streptococci
• transfer of the common cold, Influenza, the virus diseases of
childhood and tuberculosis by droplet infection
(c) Droplet Nuclei
• The smaller droplets evaporate quickly
• they contain saliva or mucous
• the residue consists of tiny protcin flakes carrying any
organisms previously in suspension.
(d ) Free Micro-organisms
• naked yeasts and mould spores are often abundant.
9. People are the greatest source of
contamination
Sneezing produces 100,000 –200,000 aerosol
droplets which can then attach to dust
particles
10. 2. The Breath
• in normal breathing few organisms pass into the
atmosphere
• coughing, sneezing and spitting can cause contamination
• Haemolytic streptococci and Staphylococcus aureus present
in the noses and throats
• Staphylococcus aureus is found just inside the nostrils
11. 3. The Hands
• major means of transmitting infection.
• there are not less than 10 000 organisms per cm 2 of normal
skin
• Organisms fall into 2 groups:
• The Resident Flora: bacteria can live and multiply on the
surface of the skin or in the hair follicle and the ducts of
sebaceous glands
• Eg. Mostly non-pathogen; Staphylococcus occasionally
aureus.
• The Transient Flora: composed of organisms collected from
the environment or from other parts of the body.
12. 4. Clothing
• Atmospheric dust becomes entangled in the fibres of
fabrics is dislodged by body movements
• Can raise the level of contamination around a person
who is working carelessly.
• A special danger is the load of contaminated
particles shed from a handkerchief that has dried
after previous use.
13. 5. The Hair
• Hair is constantly exposed-to atmospheric
dust
• Atmospheric dust becomes entangled in the
hair
• Dust may liberate during ?
14. 6. The Working Surface
• organisms sediment on the surface
7. Equipment
• In aseptic technique no source of
contamination is more serious than unsterile
equipment.
15. THE DESIGN OF AN ASEPSIS LABORATORY
A.Site
• site the asepsis laboratory as far as possible from the rooms
to which non-pharmaceutical staff have access.
• should be away from stairs, lifts and corridors
• should contain few or no storage facilities,
• the sterile equipment and products store must be adjacent or
near by.
• access to the lab should be through one or 'more rooms with
washing and changing facilities.
16. B. Size
• the maximum number of people using the asepsis room at
any one time.
• a large, fairly high room is more pleasant to work in
• the overall level of micro-organisms in its atmosphere is less
affected by
– local air disturbances or
– contamination produced by individual workers.
• cleaning the upper walls and ceiling, often neglected
17. • a small room is more economical
– the capital and maintenance costs of the equipment are
reduced
• for controlling the microbial content
• temperature and
• humidity of the atmosphere
– Cleaning is easier if the ceiling is low.
.
• the room must be much bigger for
– preparing heat-sterilised injections, including infusion
fluids.
• The clean atmosphere greatly assists the production of
particle-free solutions.
18. C. Windows
• not pleasant to work day after day in a windowless
room
• efficiency is likely to suffer
• bright sunshine is the best detector of dust
• Large windows of clear glass are most acceptable to
staff BUT they must not open
• ventilation should be provided by an air-filtration
system.
• The heat losses that occur from extensive areas of
glass can be reduced by double glazing
• Shading from the sun in summer can be given by a
venetian blind.
19. D. Doors
Air lock with double door
• If possible, the laboratory should be entered through
an air-lock with double doors about 1 m apart
• this process prevents a sudden inrush of air when the
door is opened
• The method of using the lock is to confirm first that
the door to the laboratory is shut
• for this, a small window is needed in the outer one.
• Then enter in the air-lock
• after the outer door has been closed again
• the laboratory door can be opened.
20. Sliding doors
• Less air disturbances
• Create dust traps
• not be opened easily without using the
hands
21. Swing doors
• generally fit better, particularly if their
openings are surrounded with insulation strip.
• They can be made to push open and,
therefore, can be foot-operated;
• but footplates are necessary to protect the
wood.
22. E. Surfacing Materials
The floors, walls and bench tops of an asepsis room
must be
• (a) Easily cleaned-frequent washing will be necessary
to prevent accumulation of dirt.
• (b) Smooth--cleaning is easier if there are no cracks
and pores in which dust and micro-organisms can
lodge.
• (c) Impervious, e.g. to cleaning agents and spilt
liquids.
• (d) Resistant to chemicals. They should not be
softened or swollen by solvents, stained
permanently by dyes or damaged by strong acids or
alkalis.
23. 1. FLOORS:
The most suitable are
(a) Terrazzo
• a mixture of cement and
crushed marble.
• both can be coloured.
• It is spread in plastic form
on the site or is
obtainable as tiles.
24. Terrazzo Floor
• It stands up to energetic cleaning and, if
desired, the floor can be gently sloped to
carry the water away.
• It is expensive, cold, ,tiring to stand on,
noisy, slippery when wet, and badly
marked by rubber- heels.
• It is attacked by acids and stained by dyes
but can be given a protective surface to
increase its resistance.
25. (b) Linoleum
• Heavy grade linoleum
has many good
features.
• It is in-expensive,
reasonably warm,
comfortable, quiet,
obtainable in many
colours and easily
cleaned.
• Sheet and tile forms
are available
• The polished surface is
slippery when wet
27. • (C) Plastics
• The non-slip or matt finish grades of PVC are
suitable.
• Obtainable as sheets or tiles
• The polished surface is very slippery
• Oils and organic solvents attack it
• Dyes are absorbed
28. 2. WALLS AND CEILINGS
The possible surfaces are
(a) Tiles:
• Good quality modern tiles seem more satisfactory
• Ceramic surfaces are cold
• not stand up to hard knocks.
(b) Hard Gloss Paint on Smooth Plaster
• Gloss paint is inexpensive and quite satisfactory
• must be renewed as soon as cracking or peeling begins.
• Plaster walls are easily damaged
(c) Plastic Laminated Board
• This material has been used for covering the walls and
ceilings of asepsis rooms in industry.
• The cost is high.
29. 2. WALLS AND CEILINGS
(c) Plastic Laminated
Board
• This material has
been used for
covering the walls
and ceilings of
asepsis rooms in
industry.
• The cost is high.
30. 3. BENCH TOPS
• The most popular surfaces for asepsis work are-
(a) Stainless Steel
• This is virtually indestructible.
• solution of iodine: one that noticeably attacks it.
• The attaching screws should be under the bench
31. 3. Bench Tops
(b) Plastic Laminates
• The major advantages
– bright colouring
– lower cost.
• less noisy and not cold
• Although their heat resistance is good, the
radiation from an autoclave can raise and distort
the laminate
• Resistant to reagents, except strong solutions of
phenols
• although dyes cause staining this is easily
removed if treatment is not delayed.
32. F. Services
An asepsis laboratory will require many, if not all, of the
following services-
(a) Ventilation: This may include removal of micro-
organisms, control of humidity and temperature, and
provision of fresh air.
(b) Electricity: for lighting and sometimes for a hot-plate,
ultraviolet lamp, aerosol producer or vacuum pump.
(c) Gas: for the Bunsen burner.
(d) Compressed air and or vacuum: for clarification and
bacterial filtration.
33. 1. ELECTRICITY
• Strip lighting is the most
pleasant to work in.
• Dust-collecting surfaces
within the room can be
avoided by fitting the tubes
above flush glass or plastic
panels in a false ceiling
• Switches and sockets should
be flush fitting and have
finger plates of plastic
• Most of the controls can be
outside the room
• A red indicator window above
34. 2. GAS
• Gas cocks may be on the wall or at the back of the
bench but the controls must be easy to reach.
3. COMPRESSED AIR AND VACUUM
• Some types of rotary Pump can separately
provide both these services.
• Pumps are noisy and are best housed outside the
laboratory
35. 4. NITROGEN
• A cylinder can be kept near to the vacuum pump
5. WATER
• It is difficult to justify a water supply in the
laboratory itself.
• Hand-washing facilities are undesirable.
• Water baths can be filled in the washing room
• water baths are sometimes needed to melt or softer-
semi-solid bases or to heat anaerobic culture media
36. Others Services
• In a hospital - two or three sinks may be enough
but
• in industry much larger facilities are essential.
• Stands of the drinking fountain type are
economical
• Soap is conveniently supplied, in liquid form, from
dispensers on the wall or on the tops of fountains.
• Electric hand-driers are often very large, are
usually slow and cause considerable air
disturbance;
• paper towels, sterile if preferred, are an
acceptable alternative.
• in some industrial suites showers are provided
37. 6. WASTE DISPOSAL
• Wrapping paper, bags, plugs, pieces of twine, elastic
bands, tops of ampoules etc. collect during aseptic
technique and must be cleared from the working
surface immediately.
• A foot-operated waste-bin is popular
• a metal ring can be clipped under or out from the
bench and a plastic or stainless bucket or large bowl
can be slipped into the ring
• this can be close enough to the hands to make
effective use
38. G. Furniture
1. BENCHES
• conventional benching may be replaced by tables or
wall-mounted work shelves to reduce dust collection
and facilitate its detection and removal
• When storage space is considered essential, cup-
boards are preferable to drawers
• The cupboards should be dustproof
• To assist cleaning, as many surfaces as cost per-mits
should be faced with plastic laminate
39. 2. SEATS
• These must be adjustable and comfortable.
• user's face is well above the front opening of the
screen - breath is kept away from the materials
underneath.
• Comfort is best assured by chairs rather than stools
3. TROLLEYS
• Trolleys with removable trays, preferably of stainless
steel, are better
• They are easy to clean,
• can be taken away for replenishment and,
• if necessary, the trays can be steam-sterilised.
40. 4. DOORMAT
• The soles of outdoor shoes are heavily
contaminated
• unless special footwear is worn in the laboratory,
it is useful to have, in the air-lock, a mat part-
immersed in a detergent-disinfectant solution.
• Mats are obtainable,in which the upper part has a
honeycomb structure for holding liquid
disinfectant
• Johnson and Johnson, Slough, developed a
disposable adhesive-faced pad that fits into an
aluminium frame
• The resinous facing traps dirt but does not adhere
to shoes or the wheels of trolleys.
41. 5. SCREENS
• Aseptic technique is carried out under a screen.
• (a) Shack Types
• Originally these consisted of a wooden case with a
sloping front of glass
• Plastic screens are transparent,
– giving excellent visibility of the contents, and
– light in weight, which makes them easy to move
about.
– The sloping front should raise for the introduction
of large items of equipment such as a balance.
– If clean air is supplied to the room, there is no
need to enclose the screen front and work
through arm-holes-or rubber sleeves
42. (b) Fume-cupboard Types
• Tall apparatus, such as burettes,
has to project through a hole in
the screen top when used with
the shack type.
• Fume cupboard types are high
enough for this equipment to fit
entirely inside.
43. Summary of the Lecture
• What is aseptic technique?
• Terminal heat treatment is not possible in several classes of
product.
• Sources of contamination
• The Atmosphere
– What are the Types of contamination
• Dust
• Droplets
• Droplets nuclei
• Free microorganism
• The Breath
• The Hands
• Clothing
• The Hair
• The working surfaces
• Equipment
44. Summary of the Lecture (Contd.)
The Design of an Asepsis Laboratory
– A. Site – F. Services
– B. Size • Electricity
– C. Windows • Gas
– D. Doors • Compressed air and vacuum
– E. Surfacing Materials • Nitrogen
• 1. Floors • Water
• 2. Walls and Ceilings • Waste disposal
(a) Tiles
– G. Furniture
(b) Hard Gloss Paint on • Benches
Smooth Plaster • Seats
(c) Plastic Laminated • Trolleys
Board • Doormat
• 3. Bench Tops • Screens
(a) Stainless Steel – Shack Type
(b) Plastic laminates – Fume-cupboard Types
45. • Saprophytes: Organisms living on dead or decaying
organic matter that help natural decomposition of
organic matter in water.
• Cocci: Spherical shaped Bacteria
• Sarcina
A genus of bacteria found in various
organic fluids, especially in those those of
the stomach, associated with certain
diseases.
Editor's Notes
Sebaceous glands: glands in the skin that secrete oil to the surface of the skin