Aseptic techniques are employed to provide protection to ophthalmic and parenteral products by preventing the entry of microbial and particulate contamination.
Prevention of microbial contamination is also required to remove pyrogens and toxic bacterial products.
This document discusses the design and operation of an aseptic area for producing sterile pharmaceutical products. It describes the different sections of the aseptic area including the clean-up, compounding, aseptic, quarantine, and packaging/labeling areas. It provides details on airflow, filtration, surfaces, clothing, cleaning procedures, and sources of potential contamination. The goal is to maintain sterile conditions and limit contamination that could compromise the sterile products being produced.
Designing of aseptic area including design, construction, service, flow chart,source of contamination, method of prevention of it,clean area classification as per USPDA.
1) An aseptic area is a sterile environment designed to prevent microbial contamination of products. It must control dust and avoid provisions for microbes to enter.
2) Laminar flow equipment uses HEPA filters to blow sterile air and prevent contamination when performing sensitive tasks. It maintains sterile conditions.
3) Sources of contamination in an aseptic area include airborne microbes, operators, raw materials, and equipment that are not properly sterilized or stored. Maintaining aseptic technique and conditions is important to prevent contamination.
Definition of drying
Importance of drying
Difference between drying and evaporation
Drying is defined as removal of the liquid from a material by application of heat & is accomplished by transfer of a liquid from the surface into an unsaturated vapor phase .
Drying is the final removal of water from material (usually by heat)
Drying is commonly the last stage in a manufacture process
Non-thermal drying
1- As Squeezing wetted sponge
2- Adsorption by desiccant (desiccation)
3- Extraction.
Preservation of drug products
Preparation of bulk drugs
Improved handling
Improved characteristics
Equipments
Drying is necessary in order to avoid deterioration. A few examples are…
--blood products, tissues… undergo microbial growth
--effervescent tablets, synthetic & semi synthetic drugs undergo…. chemical decomposition.
Sterility testing products (solids, liquids, ophthalmic and other sterile pro...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-IIIPart-6 Sterility testing products (solids, liquids, ophthalmic and other sterile products) according to IP, BP, USP.
Introduction: Test for Sterility. Culture Media. Fluid Thioglycollate Medium (FTM).
Alternative Thioglycollate Medium (ATM).
Soybean Casein Digest Medium (SCDM).
Tests for Culture Media:
Sterility of Media.
Growth Promotion Test.
Test for Bacteriostatic and Fungistatic.
Sterility Test Methods. Methods A: Membrane Filtration.
Method B: Direct Inoculation Pyrogen Test Methods. Rabbit Test. LAL Test.
This document describes the design and construction of an aseptic area for sterile pharmaceutical production. It outlines the key sections of an aseptic area including a clean-up area, compounding section, aseptic filling area, quarantine section, and packing/labeling area. It emphasizes that strict control measures must be implemented to prevent contamination, including the use of protective clothing by personnel, regular cleaning and disinfection, and maintaining sterility. The construction of aseptic rooms is also discussed, noting the use of smooth cleanable materials, sealed ceilings and fittings, and exclusion of drains and sinks.
This document provides an introduction to pharmaceutical clean rooms. It discusses the purpose of clean rooms which is to promote successful cleanroom operations and ensure safety. Clean rooms are classified according to international standards based on the number of permitted particles per cubic meter of air. Sources of contamination are discussed as well as methods for contamination control including personnel control, environmental control, and atmospheric monitoring. The conclusion states that the main purpose of a clean room is to prevent contamination of products and ensure quality according to good manufacturing practices.
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 the design and operation of an aseptic area for producing sterile pharmaceutical products. It describes the different sections of the aseptic area including the clean-up, compounding, aseptic, quarantine, and packaging/labeling areas. It provides details on airflow, filtration, surfaces, clothing, cleaning procedures, and sources of potential contamination. The goal is to maintain sterile conditions and limit contamination that could compromise the sterile products being produced.
Designing of aseptic area including design, construction, service, flow chart,source of contamination, method of prevention of it,clean area classification as per USPDA.
1) An aseptic area is a sterile environment designed to prevent microbial contamination of products. It must control dust and avoid provisions for microbes to enter.
2) Laminar flow equipment uses HEPA filters to blow sterile air and prevent contamination when performing sensitive tasks. It maintains sterile conditions.
3) Sources of contamination in an aseptic area include airborne microbes, operators, raw materials, and equipment that are not properly sterilized or stored. Maintaining aseptic technique and conditions is important to prevent contamination.
Definition of drying
Importance of drying
Difference between drying and evaporation
Drying is defined as removal of the liquid from a material by application of heat & is accomplished by transfer of a liquid from the surface into an unsaturated vapor phase .
Drying is the final removal of water from material (usually by heat)
Drying is commonly the last stage in a manufacture process
Non-thermal drying
1- As Squeezing wetted sponge
2- Adsorption by desiccant (desiccation)
3- Extraction.
Preservation of drug products
Preparation of bulk drugs
Improved handling
Improved characteristics
Equipments
Drying is necessary in order to avoid deterioration. A few examples are…
--blood products, tissues… undergo microbial growth
--effervescent tablets, synthetic & semi synthetic drugs undergo…. chemical decomposition.
Sterility testing products (solids, liquids, ophthalmic and other sterile pro...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-IIIPart-6 Sterility testing products (solids, liquids, ophthalmic and other sterile products) according to IP, BP, USP.
Introduction: Test for Sterility. Culture Media. Fluid Thioglycollate Medium (FTM).
Alternative Thioglycollate Medium (ATM).
Soybean Casein Digest Medium (SCDM).
Tests for Culture Media:
Sterility of Media.
Growth Promotion Test.
Test for Bacteriostatic and Fungistatic.
Sterility Test Methods. Methods A: Membrane Filtration.
Method B: Direct Inoculation Pyrogen Test Methods. Rabbit Test. LAL Test.
This document describes the design and construction of an aseptic area for sterile pharmaceutical production. It outlines the key sections of an aseptic area including a clean-up area, compounding section, aseptic filling area, quarantine section, and packing/labeling area. It emphasizes that strict control measures must be implemented to prevent contamination, including the use of protective clothing by personnel, regular cleaning and disinfection, and maintaining sterility. The construction of aseptic rooms is also discussed, noting the use of smooth cleanable materials, sealed ceilings and fittings, and exclusion of drains and sinks.
This document provides an introduction to pharmaceutical clean rooms. It discusses the purpose of clean rooms which is to promote successful cleanroom operations and ensure safety. Clean rooms are classified according to international standards based on the number of permitted particles per cubic meter of air. Sources of contamination are discussed as well as methods for contamination control including personnel control, environmental control, and atmospheric monitoring. The conclusion states that the main purpose of a clean room is to prevent contamination of products and ensure quality according to good manufacturing practices.
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 distillation, which is a process used to separate mixtures based on differences in their boiling points. It defines distillation and provides examples of its applications. It then classifies different types of distillation, including simple distillation, fractional distillation, vacuum distillation, and molecular distillation. For each type, it provides a brief overview of the principle, construction, working, and some applications. The document is presented by an assistant professor and provides detailed information on various distillation methods.
Designing of aseptic area, laminar flow equipment: Study of different source ...Ms. Pooja Bhandare
Designing of aseptic area, laminar flow equipment: Study of different source of contamination in aseptic area and methods of prevention, clean area classification. PHARMACEUTICALMICROBIOLOGY (BP303T)Unit-IVPart-1
Introduction: Designing of Aseptic Area . i) The clean-up area,
ii) The compounding area,
iii) The aseptic area,
iv) The quarantine area and
v) The packaging/labelling area.
Flow diagram of aseptic area. Floors, walls and ceilings, Doors, windows and services Personnel and protective clothing Cleaning and disinfection. Air Supply. Laminar flow equipment. Vertical laminar air flow bench
Horizontal laminar air flow bench
High Efficiency Particulate Air (HEPA) Filter. Operating Instructions Uses of Laminar Air Flow.Advantages of Laminar Air Flow.Limitations of Laminar Air Flow. Air flow pattern Unidirectional airflow
Non-unidirectional airflow
Combined airflow
Different Sources of Contamination in an Aseptic Area
1) Personnel:
2) Buildings and Facilities
3) Equipment and Utensils:
4) Raw Materials
5) Manufacturing Process:
Methods of Prevention of Contamination Clean Area Classification
Study of principle, procedure, merits, demerits and applications of physical,...Ms. Pooja Bhandare
This document discusses various methods of sterilization including physical, chemical, gaseous, radiation, and mechanical methods. It provides details on heat sterilization methods like dry heat sterilization using an oven and moist heat sterilization using an autoclave. It also describes radiation sterilization methods like UV and gamma irradiation. Finally, it covers mechanical sterilization through filtration using filters like sintered glass, ceramic candles, and membranes.
Types of spoilage, factors affecting the microbial spoilage of pharmaceutical...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-V Part-1
Types of spoilage, factors affecting the microbial spoilage of pharmaceutical products, source and type of contaminants. Introduction: Defintion Types of Microbial Spoilage:
1. Infection induced due to contaminated pharmaceutical products: Table no. 1.1 Common pathogens spoiling pharmaceutical products:
2. Physicochemical spoilage –
i) Viable growth ii) Gas production
iii) Colouration / Decolouration
iv) Odour formation
v) Taste change
3. Physical Spoilage:
Cracking of emulsion:
Odor changes
4. Biological spoilage:
Microbial Toxins
Microbial Metabolites
5. Chemical spoilage: Table 1.2 Susceptibility of pharmaceutical ingredients to microbial contamination
Factors affecting microbial spoilage
Size of contaminant inoculum
Nutritional factors
Moisture content
pH
Storage temperature
Redox potential
Packaging design
Sources and Types Of Contamination:
Personnel,
Poor facility design,
Incoming ventilation air,
Machinery and other equipment for production,
Raw material and semi-finished material,
Packaging material,
Utilities,
Different media used in the production process as well as for cleaning and Cleanroom clothing.
PHARMACEUTICAL MICROBIOLOGY (BP303T) Unit-III Part-1 Study of morphology, cla...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-IIIPart-1Study of morphology, classification, reproduction/replication and cultivation of fungi, Introduction fungi. Morphological Characteristics of fungi, CLASSIFICATION: Depending on cell morphology, fungi can be divided into 4 classes:
Moulds Yeasts ,Yeast like fungi and
Dimorphic fungi
Depending on their sexual spores formation fungi are divided into 4 classes:
Zygomycetes Ascomycetes
Basidiomycetes Dueteromycetes
Reproduction and sporulation;Vegetative, Asexual
and Sexual
Vegetative reproduction: Fragmentation ,Fission, budding, Sclerotia Rhizomorphs
Asexual reproduction: Zoospores
Sporangiospore, Conidia
Oidia Uredospores ,Basidiospores
Sexual reproduction:Planogametic copulation: Isogamy Heterogamy
Gametangial contact
Gametangial copulation Spermatization Somatogamy CULTIVATION OF FUNGI: Brain Heart Infusion (BHT) agar
Czapek’s agar
Mycobiotic agar Inhibitory mold agar (IMA)
Potato dextrose agar
Sabouraud’s dextrose agar (SDA):
Sabouraud’s heart infusion (SABHI) agar
Potato Flake agar
Potato dextrose-yeast extract agar (PDYA)
. Cornmeal agar
Malt extract agar (MEA)
Aseptic Area and Microbial Control. - Pharmaceutical Microbiology (SYBpharm) ...Kiran Shinde
Prof.Mr.Kiran K. Shinde (M.Pharm), Assistant professor (VNIPRC)
Pharmaceutical microbiology (Second year b.pharm) (3rd semester)
Introduction to Aseptic area & room
Designing of Aseptic Room
Laminar Airflow Equipment
Sources of Contamination & Method of Prevention
Classification of Aseptic Area-Room
Testing of Clean Aseptic Room
Contamination control and sterile manufacturingGeorge Wild
Microorganisms like bacteria, viruses, and fungal spores pose a contamination risk in sterile manufacturing. Cleanrooms with strict particle and airflow controls are needed. Personnel procedures aim to minimize shedding of microbes. Sterilization methods like heat aim to achieve a sterility assurance level of 1 in 1 million by killing all microbes or reducing their number below acceptable levels. Key factors in sterilization include the bioburden level and resistance of the most durable microorganism strain present.
A sterile area is required for tissue culture labs to prevent contamination. The document outlines requirements for the sterile area including filtering air with HEPA filters, maintaining positive pressure, limiting windows and doors. It also lists essential equipment for cell culture like laminar flow cabinets, incubators, centrifuges, microscopes, and autoclaves. Proper hygiene is important as well, with researchers wearing protective coats, masks, gloves and goggles.
The document discusses the key factors to consider when selecting materials for pharmaceutical plant construction. Material selection depends on chemical factors like potential for contamination or corrosion, physical factors like strength and thermal properties, and economic factors. A wide range of materials may be used, and the choice is based on expert advice, experience, and testing given pharmaceuticals can have varying chemical properties and manufacturing requires withstanding various temperatures, pressures, and stresses. Proper material selection is important for product quality and plant success.
The document discusses aseptic areas and contamination prevention. It defines an aseptic area as one that is free from microbes. When designing an aseptic area, considerations include adequate space, material flow, easily cleaned surfaces, separate work areas, and HEPA filtered air. Contamination can occur from internal factors like improper practices, external factors like poor attire, or manual factors like careless handling. Prevention focuses on personnel, buildings/facilities, equipment, materials, manufacturing processes, and HVAC systems. Microbial assays are used to analyze compounds' impact on microorganisms and estimate antibiotic concentration and efficiency.
Fluid energy mill for pharmacy principles, construction, working, uses, meri...ASHUTOSH SENGAR
this is an slideshare for pharmacy students, principles, construction, working, uses, merits and
demerits of , fluid energy mill its for b. pharm. and M. PHARM
This document discusses stability testing of pharmaceutical packaging. Stability testing ensures that packaging maintains the quality of drugs over time under various environmental conditions like temperature, humidity and light. It involves testing packaging for leakage, strength, impact of distribution processes, and compatibility with drugs. The document outlines guidelines for conducting stability tests, including storage conditions, timepoints for sampling, and parameters to evaluate like appearance, assay and degradation. The goal is to determine shelf life and ensure patient safety.
The document discusses the raw materials and nutritional requirements for bacterial culture media. It outlines that quality water, agar, peptone, casein hydrolysate, meat extract, yeast extract, and malt extract are important raw materials. It also discusses the roles of macro and micronutrients like carbon, nitrogen, phosphorus and trace elements. Carbon sources like glucose provide energy, while buffers and indicators are also added. Nutritional requirements include vitamins, growth factors, and a balanced mix of major and minor elements to support bacterial growth.
This document discusses coating pans used in the pharmaceutical industry. It describes two main types of coating pans - conventional and perforated. Conventional pans include Pelligrini, immersion sword, and immersion tube pans. Perforated pans have openings that improve mixing and drying efficiency, examples given are Accela-Cota, Hi-Coater, Dria Coater, and Glatt pans. The validation process for coating pans involves installation qualification to confirm proper installation, operational qualification to establish operating parameters, and performance qualification to verify operation as intended.
This document discusses aerosols, including their definition, advantages, disadvantages, classification, formulation, containers, packaging, and applications. It notes that aerosols are dispersions of fine particles or liquid droplets in a gas, and are also called pressurized dosage forms. Common propellants are mentioned, and it is explained that aerosol formulations can be two-phase or three-phase systems. Important uses of aerosols include topical and respiratory drug delivery.
Central sterilization supply departmentAshraf selim
The document discusses concepts and procedures for central sterilization and supply departments (CSSD). It covers general planning concepts like airflow, staff flow and workflow. It also discusses criteria for CSSD areas including changing rooms, wall finishes and lighting. The document then outlines the steps for cleaning, drying, inspecting, packaging, loading and storing sterilized instruments as well as environmental parameters and storage time protocols. The overall goal is to prevent contamination and effectively reprocess reusable medical equipment to maintain sterility.
This document discusses the design of an aseptic area for sterile product production. Key points include:
1) The aseptic area must have strict control measures to avoid contamination, with particle counts not exceeding 100 particles/ft3 of 5μm or larger.
2) The area includes sub-areas like cleanup, compounding, and packaging. Floors, walls and ceilings must be smooth, easy to clean, and minimize contamination.
3) Doors, windows and pipes must be properly sealed to control airflow and prevent entry of contaminants. Staff must be trained, wear protective clothing, and follow disinfection procedures.
This document discusses distillation, which is a process used to separate mixtures based on differences in their boiling points. It defines distillation and provides examples of its applications. It then classifies different types of distillation, including simple distillation, fractional distillation, vacuum distillation, and molecular distillation. For each type, it provides a brief overview of the principle, construction, working, and some applications. The document is presented by an assistant professor and provides detailed information on various distillation methods.
Designing of aseptic area, laminar flow equipment: Study of different source ...Ms. Pooja Bhandare
Designing of aseptic area, laminar flow equipment: Study of different source of contamination in aseptic area and methods of prevention, clean area classification. PHARMACEUTICALMICROBIOLOGY (BP303T)Unit-IVPart-1
Introduction: Designing of Aseptic Area . i) The clean-up area,
ii) The compounding area,
iii) The aseptic area,
iv) The quarantine area and
v) The packaging/labelling area.
Flow diagram of aseptic area. Floors, walls and ceilings, Doors, windows and services Personnel and protective clothing Cleaning and disinfection. Air Supply. Laminar flow equipment. Vertical laminar air flow bench
Horizontal laminar air flow bench
High Efficiency Particulate Air (HEPA) Filter. Operating Instructions Uses of Laminar Air Flow.Advantages of Laminar Air Flow.Limitations of Laminar Air Flow. Air flow pattern Unidirectional airflow
Non-unidirectional airflow
Combined airflow
Different Sources of Contamination in an Aseptic Area
1) Personnel:
2) Buildings and Facilities
3) Equipment and Utensils:
4) Raw Materials
5) Manufacturing Process:
Methods of Prevention of Contamination Clean Area Classification
Study of principle, procedure, merits, demerits and applications of physical,...Ms. Pooja Bhandare
This document discusses various methods of sterilization including physical, chemical, gaseous, radiation, and mechanical methods. It provides details on heat sterilization methods like dry heat sterilization using an oven and moist heat sterilization using an autoclave. It also describes radiation sterilization methods like UV and gamma irradiation. Finally, it covers mechanical sterilization through filtration using filters like sintered glass, ceramic candles, and membranes.
Types of spoilage, factors affecting the microbial spoilage of pharmaceutical...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-V Part-1
Types of spoilage, factors affecting the microbial spoilage of pharmaceutical products, source and type of contaminants. Introduction: Defintion Types of Microbial Spoilage:
1. Infection induced due to contaminated pharmaceutical products: Table no. 1.1 Common pathogens spoiling pharmaceutical products:
2. Physicochemical spoilage –
i) Viable growth ii) Gas production
iii) Colouration / Decolouration
iv) Odour formation
v) Taste change
3. Physical Spoilage:
Cracking of emulsion:
Odor changes
4. Biological spoilage:
Microbial Toxins
Microbial Metabolites
5. Chemical spoilage: Table 1.2 Susceptibility of pharmaceutical ingredients to microbial contamination
Factors affecting microbial spoilage
Size of contaminant inoculum
Nutritional factors
Moisture content
pH
Storage temperature
Redox potential
Packaging design
Sources and Types Of Contamination:
Personnel,
Poor facility design,
Incoming ventilation air,
Machinery and other equipment for production,
Raw material and semi-finished material,
Packaging material,
Utilities,
Different media used in the production process as well as for cleaning and Cleanroom clothing.
PHARMACEUTICAL MICROBIOLOGY (BP303T) Unit-III Part-1 Study of morphology, cla...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-IIIPart-1Study of morphology, classification, reproduction/replication and cultivation of fungi, Introduction fungi. Morphological Characteristics of fungi, CLASSIFICATION: Depending on cell morphology, fungi can be divided into 4 classes:
Moulds Yeasts ,Yeast like fungi and
Dimorphic fungi
Depending on their sexual spores formation fungi are divided into 4 classes:
Zygomycetes Ascomycetes
Basidiomycetes Dueteromycetes
Reproduction and sporulation;Vegetative, Asexual
and Sexual
Vegetative reproduction: Fragmentation ,Fission, budding, Sclerotia Rhizomorphs
Asexual reproduction: Zoospores
Sporangiospore, Conidia
Oidia Uredospores ,Basidiospores
Sexual reproduction:Planogametic copulation: Isogamy Heterogamy
Gametangial contact
Gametangial copulation Spermatization Somatogamy CULTIVATION OF FUNGI: Brain Heart Infusion (BHT) agar
Czapek’s agar
Mycobiotic agar Inhibitory mold agar (IMA)
Potato dextrose agar
Sabouraud’s dextrose agar (SDA):
Sabouraud’s heart infusion (SABHI) agar
Potato Flake agar
Potato dextrose-yeast extract agar (PDYA)
. Cornmeal agar
Malt extract agar (MEA)
Aseptic Area and Microbial Control. - Pharmaceutical Microbiology (SYBpharm) ...Kiran Shinde
Prof.Mr.Kiran K. Shinde (M.Pharm), Assistant professor (VNIPRC)
Pharmaceutical microbiology (Second year b.pharm) (3rd semester)
Introduction to Aseptic area & room
Designing of Aseptic Room
Laminar Airflow Equipment
Sources of Contamination & Method of Prevention
Classification of Aseptic Area-Room
Testing of Clean Aseptic Room
Contamination control and sterile manufacturingGeorge Wild
Microorganisms like bacteria, viruses, and fungal spores pose a contamination risk in sterile manufacturing. Cleanrooms with strict particle and airflow controls are needed. Personnel procedures aim to minimize shedding of microbes. Sterilization methods like heat aim to achieve a sterility assurance level of 1 in 1 million by killing all microbes or reducing their number below acceptable levels. Key factors in sterilization include the bioburden level and resistance of the most durable microorganism strain present.
A sterile area is required for tissue culture labs to prevent contamination. The document outlines requirements for the sterile area including filtering air with HEPA filters, maintaining positive pressure, limiting windows and doors. It also lists essential equipment for cell culture like laminar flow cabinets, incubators, centrifuges, microscopes, and autoclaves. Proper hygiene is important as well, with researchers wearing protective coats, masks, gloves and goggles.
The document discusses the key factors to consider when selecting materials for pharmaceutical plant construction. Material selection depends on chemical factors like potential for contamination or corrosion, physical factors like strength and thermal properties, and economic factors. A wide range of materials may be used, and the choice is based on expert advice, experience, and testing given pharmaceuticals can have varying chemical properties and manufacturing requires withstanding various temperatures, pressures, and stresses. Proper material selection is important for product quality and plant success.
The document discusses aseptic areas and contamination prevention. It defines an aseptic area as one that is free from microbes. When designing an aseptic area, considerations include adequate space, material flow, easily cleaned surfaces, separate work areas, and HEPA filtered air. Contamination can occur from internal factors like improper practices, external factors like poor attire, or manual factors like careless handling. Prevention focuses on personnel, buildings/facilities, equipment, materials, manufacturing processes, and HVAC systems. Microbial assays are used to analyze compounds' impact on microorganisms and estimate antibiotic concentration and efficiency.
Fluid energy mill for pharmacy principles, construction, working, uses, meri...ASHUTOSH SENGAR
this is an slideshare for pharmacy students, principles, construction, working, uses, merits and
demerits of , fluid energy mill its for b. pharm. and M. PHARM
This document discusses stability testing of pharmaceutical packaging. Stability testing ensures that packaging maintains the quality of drugs over time under various environmental conditions like temperature, humidity and light. It involves testing packaging for leakage, strength, impact of distribution processes, and compatibility with drugs. The document outlines guidelines for conducting stability tests, including storage conditions, timepoints for sampling, and parameters to evaluate like appearance, assay and degradation. The goal is to determine shelf life and ensure patient safety.
The document discusses the raw materials and nutritional requirements for bacterial culture media. It outlines that quality water, agar, peptone, casein hydrolysate, meat extract, yeast extract, and malt extract are important raw materials. It also discusses the roles of macro and micronutrients like carbon, nitrogen, phosphorus and trace elements. Carbon sources like glucose provide energy, while buffers and indicators are also added. Nutritional requirements include vitamins, growth factors, and a balanced mix of major and minor elements to support bacterial growth.
This document discusses coating pans used in the pharmaceutical industry. It describes two main types of coating pans - conventional and perforated. Conventional pans include Pelligrini, immersion sword, and immersion tube pans. Perforated pans have openings that improve mixing and drying efficiency, examples given are Accela-Cota, Hi-Coater, Dria Coater, and Glatt pans. The validation process for coating pans involves installation qualification to confirm proper installation, operational qualification to establish operating parameters, and performance qualification to verify operation as intended.
This document discusses aerosols, including their definition, advantages, disadvantages, classification, formulation, containers, packaging, and applications. It notes that aerosols are dispersions of fine particles or liquid droplets in a gas, and are also called pressurized dosage forms. Common propellants are mentioned, and it is explained that aerosol formulations can be two-phase or three-phase systems. Important uses of aerosols include topical and respiratory drug delivery.
Central sterilization supply departmentAshraf selim
The document discusses concepts and procedures for central sterilization and supply departments (CSSD). It covers general planning concepts like airflow, staff flow and workflow. It also discusses criteria for CSSD areas including changing rooms, wall finishes and lighting. The document then outlines the steps for cleaning, drying, inspecting, packaging, loading and storing sterilized instruments as well as environmental parameters and storage time protocols. The overall goal is to prevent contamination and effectively reprocess reusable medical equipment to maintain sterility.
This document discusses the design of an aseptic area for sterile product production. Key points include:
1) The aseptic area must have strict control measures to avoid contamination, with particle counts not exceeding 100 particles/ft3 of 5μm or larger.
2) The area includes sub-areas like cleanup, compounding, and packaging. Floors, walls and ceilings must be smooth, easy to clean, and minimize contamination.
3) Doors, windows and pipes must be properly sealed to control airflow and prevent entry of contaminants. Staff must be trained, wear protective clothing, and follow disinfection procedures.
Parenteral preparations must be sterile and free of pathogens to safely administer drugs through non-digestive routes like injection. Strict aseptic techniques are required during production to prevent contamination. Key aspects of aseptic processing include designated clean, compounding, and aseptic areas; laminar flow hoods with HEPA filters; and trained personnel following proper gowning procedures. Sources of contamination include airborne particles, fluids, and microbes from personnel that must all be controlled to ensure sterile and safe parenteral products.
Industrial pharmacy parenteral processingSudipta Roy
The document discusses the processing of parenteral preparations, which includes 8 steps: 1) cleaning containers and equipment, 2) collecting materials, 3) preparing the product under aseptic conditions, 4) filtering, 5) filling final containers, 6) sealing containers, 7) sterilizing, and 8) evaluating, labeling, and packaging. Production requires special facilities divided into 5 sections - a clean up area, preparation area, aseptic area, quarantine area, and finishing/packaging area - to maintain sterility.
This presentation contains general guidelines and basic requirements of manufacturing of sterile medicinal products. This presentation is useful for training to the people involved in manufacturing of sterile pharmaceuticals or medicines.
The document discusses aseptic filling techniques used to minimize contamination during manufacturing of sterile drug products. It outlines three main areas of control: environmental control through clean rooms and HVAC systems, equipment control using sterilization and sanitization, and individual control with personnel hygiene and gowning. Key aspects covered include clean room classification, HEPA filters, air locks, laminar flow hoods, sterilization methods, and environmental monitoring to ensure an aseptic environment is maintained.
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.
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
This document discusses the design and operation of an aseptic area for producing sterile pharmaceutical products. It is divided into several sections:
1) The aseptic area requires strict control measures to avoid contamination, including stainless steel surfaces that do not accumulate dirt and separate mixing/storage areas. Products are transferred via pipelines for filling.
2) Adjacent areas include a cleanup section with HEPA-filtered air, a compounding section that controls dust, a quarantine storage area, and a packaging/labeling room.
3) Contamination can originate from the atmosphere, fluids, or personnel/equipment and is prevented through measures like filtered air, purified water, and sterile protective clothing for operators. Proper airflow
The document discusses the design of aseptic areas for sterile product production. It outlines several key aspects of aseptic area design including:
- Dividing the production area into clean-up, compounding, aseptic, quarantine, and packaging areas.
- Using smooth, cleanable materials like stainless steel, glass or epoxy paint for floors, walls and ceilings.
- Fitting doors and windows flush to walls and maintaining positive air pressure and airflow.
- Supplying high-efficiency filtered air through HEPA filters and laminar airflow benches.
- Controlling airflow patterns to avoid particle generation and maintaining cleanroom classifications.
This document discusses manufacturing considerations for ophthalmic dosage forms. It begins by defining ophthalmic preparations and listing their key requirements like sterility, tonicity, and avoidance of particulates. It then covers the manufacturing environment, personnel requirements, equipment needs, raw materials, and process analytical technology (PAT). Specific manufacturing operations for ophthalmic preparations in glass and plastic containers are outlined, including areas, equipment, and processing steps for water management, container preparation, solution preparation, filling/capping, sterilization, inspection, and packaging. Common ophthalmic dosage forms and their advantages and disadvantages are also briefly mentioned.
GMP requirements and standards govern the production of sterile pharmaceutical products to ensure quality, consistency, safety and sterility. Sterile areas where these products are manufactured must tightly control particles and other environmental factors. They are classified into grades A through D depending on their risk of contamination during production activities such as component preparation, product filling, and terminal sterilization. Personnel, facilities, equipment and processes must all be carefully designed, operated and maintained to minimize any risk of microbial contamination and to uphold stringent sterility standards.
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Glycolysis Pathway
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- Prof. S. P. Shinde.
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hematic appreciation test is a psychological assessment tool used to measure an individual's appreciation and understanding of specific themes or topics. This test helps to evaluate an individual's ability to connect different ideas and concepts within a given theme, as well as their overall comprehension and interpretation skills. The results of the test can provide valuable insights into an individual's cognitive abilities, creativity, and critical thinking skills
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Disclaimer: No one is perfect, so please mind that there might be mistakes and typos.
dtubbenhauer@gmail.com
Corrected slides: dtubbenhauer.com/talks.html
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Designing of Aseptic Area
1. Mr. S. P. Shinde
Assistant Professor
Pune, Maharashtra.
2. 2
Introduction
Mr. S. P. Shinde
❑ Aseptic techniques are employed to provide protection to ophthalmic and
parenteral products by preventing the entry of microbial and particulate
contamination.
❑ Prevention of microbial contamination is also required to remove pyrogens
and toxic bacterial products.
3. 3
Mr. S. P. Shinde
❑ The terminally sterilised products are prepared in clean areas; while products
not terminally sterilised are prepared under aseptic conditions using sterile
materials or are sterilised by filtration before being packed in sterile
containers.
❑ Such aseptic products are formulated or prepared in an aseptic area, which is
a room within a clean area designed, constructed, serviced and used for
controlling and preventing microbial contamination of the product.
Continue…
4. 4
Mr. S. P. Shinde
Designing of Aseptic Area
Office
Compounding
Area
Aseptic Filling
Area
Quarantine
Storage and
Shipping
Stock Room
Clean-up Area Sterilisation
Packaging and
Finishing Quality
Control
Flow Diagram of Aseptic Area
5. 5
Mr. S. P. Shinde
❑ The aseptic unit is designed to carry out each stage of production separately.
❑ The unit should also ensure a safe and organised workflow so that the need
for personnel to move around the clean rooms is minimised.
❑ The unit is built and the equipment is positioned in such a manner that the
product remains protected from contamination.
❑ The layout or aseptic area should be such that cleaning can be done easily and
dust accumulation can also be reduced.
❑ Arrangement should be such that the risk of cross-contamination
(contamination of one product or material with another) is reduced.
❑ The filling area should be adjacent to the compounding area where the
personnel assemble and prepare materials in the filling area.
Continue…
6. 6
Mr. S. P. Shinde
❑ Only authorised personnel enter the clean rooms by passing through the
changing rooms where they put on and remove their clean room uniform.
❑ A cross-over bench extends across the changing room to form a physical
barrier for separating the different areas for changing by the personnel.
❑ Special precautions are taken for preventing clean and aseptic filling areas
from getting contaminated while materials are being passed through
airlocks.
❑ Sterilisers and entry ports are fitted with double-sided doors, which are
interlocked to prevent simultaneous opening of both the doors.
Design and Construction
7. 7
Mr. S. P. Shinde
❑ The floor, wall and ceiling surface of clean rooms should be smooth and
unbroken to reduce the release and accumulation of contaminating
particles and organisms.
❑ The surface material should be such that they can withstand the effects of
cleaning agents and disinfectants.
❑ The ceilings are scaled so that the contaminants do not enter from the
space above them.
❑ Uncleanable recesses should be avoided within the clean rooms, thus the
wall and floor junction should be covered.
❑ Minimum shelves, ledges, cupboards and equipment should be present.
❑ Non-opening and sealed windows should be present to prevent the entry of
contaminants.
Surfacing Materials
9. 9
Mr. S. P. Shinde
❑ The piped liquids & gases entering the clean rooms should be filtered first.
❑ The position of pipes and ducts should be such that they can be easily
cleaned, other fittings like fuse boxes and switch panels should be placed
outside the clean rooms.
❑ Sink and drains should not be present in areas where aseptic procedures are
carried out within the clean room areas.
❑ The areas having sinks and drains should be designed, positioned and
maintained such that the risk of microbial contamination is reduced.
❑ A limited number of doors and ports should be present for entry of
personnel and materials, respectively.
❑ The entry doors should be self-closing to allow easy movement of the
personnel.
Services
10. 1
0
Mr. S. P. Shinde
❑ Airlock doors, wall ports, through-the-wall autoclaves and dry heat sterilisers
should have interlocked doors to prevent simultaneous opening of both the
doors.
❑ All the doors should have an alarm system which should ring when more than
one door are being opened.
❑ Lights in clean rooms should be fitted with the ceiling so that dust
accumulation reduces and also the airflow pattern within the room is not
disturbed.
❑ The equipment in clean rooms should be positioned such that accumulation of
particles and microbial contaminants does not occur.
Continue…
11. 1
1
Mr. S. P. Shinde
Laminar Airflow
❑ Laminar Airflow Hood (LAFH)/ Laminar Aseptic Hoods is defined as air
moving at the same speed and in the same direction, with no or minimal
cross-over of air streams.
❑ A High Efficiency Particulate Air (HEPA) Filter is the most important unit.
❑ The air within the room is taken into this filter and passed through a pre-filter
which removes the gross contaminants.
❑ The air is then blown at a uniform velocity through the hood and HEPA filter
in a unidirectional (laminar flow) manner over the critical sites.
❑ HEPA filter is a particulate filter which traps the airborne particles and
microbes; but allows the gases to pass through.
13. 1
3
Mr. S. P. Shinde
❑ HEPA filter should be fitted either at or near to the clean room inlet.
❑ A pre-filter is fitted upstream of the HEPA filter, thus extending the final
filter's life. A fan is also fitted which pumps the air through the filter.
❑ HEPA filters remove larger, medium, and smaller particles from the air by
inertial impaction, direct interception and by Brownian diffusion respectively.
❑ Its efficiency is 99.97% and removing particles of about 0.3μm size.
❑ It removes larger and smaller particles with more efficiency.
Continue…
14. 1
4
Mr. S. P. Shinde
Types
1) Horizontal Airflow Hoods
❑ These hoods sweep the filtered air
from the back to the front of the
hood. An electrical blower draws
the contaminated room air using a
pre-filter, to remove gross
contaminants.
❑ The pre-filter demands timely
cleanliness and replacement.
❑ The air after passing through the
pre-filter is accelerated so that a
consistent airflow distribution
reaches the final filter, present at
the back portion of the hood's
working area.
15. 1
5
Mr. S. P. Shinde
2) Vertical Airflow Hoods
❑ These hoods sweep the filtered air
vertically.
❑ The air passing through HEPA filter
merges from the top and passes
downward through the working area.
❑ When a foreign object comes in
between the sterile object and the
HEPA filter, the wind turbulence in
the critical area increases, and
foreign contaminants are carried to
the sterile work surface, thus
contaminating the injection port,
needle or syringe.
Types
16. 1
6
Mr. S. P. Shinde
1) It should be placed away from traffic, doors, air vents that can avoid entrance
of contaminants.
2) It should remain on for 24hrs otherwise, non-filtered, non-sterile air occupies
the compounding work area.
3) Before using the LAFH, its interior working surfaces should be disinfected
using 70% isopropyl alcohol (or other suitable disinfecting agents) and a clean,
lint-free cloth.
4) Cleaning should be done after every compounding batch and also when the
work surface becomes dirty. Some materials are insoluble in alcohol thus
sterile water is used initially, then cleaned using alcohol.
5) HEPA filter grill should be cleaned in such a way that it does not get wet.
6) HEPA filter should not be brought into contact with cleaning solution.
Operating Principle
17. 1
7
Mr. S. P. Shinde
7) During compounding operators should not wear any jewellery on hands or
wrists since they affect the integrity of personnel clothing.
8) The operators should minimise talking and should cough away from the
compounding work area.
9) The operators should avoid or reduce the unnecessary movement and
Smoking, eating, gum chewing and drinking are strictly prohibited in the
aseptic environment.
10) The aseptic procedures should be carried out 6 inches away from the sides
and front edge of the hood to prevent contamination.
11) Testing of primary engineering controls should be carried every 6 months
by qualified personnel.
12) Testing is required whenever the device is moved or the filter is damaged.
Continue…
18. 1
8
Mr. S. P. Shinde
1) It is used where an individual clean air environment is required for smaller
items e.g. particle sensitive electronic devices.
2) It is used for special operations in laboratories.
3) It can be used for general lab work, especially in medical, pharmaceutical,
electronic and industrial sectors.
1) The sterile area is spacious.
2) Since the sterile area does not become hot, the plant material can stay for a
longer duration.
3) Bigger flasks having wide lids can be used.
Uses
Advantages
19. 1
9
Mr. S. P. Shinde
Different Sources of Contamination in an
Aseptic Area
1) Personnel
Those supervising, performing or controlling drug manufacturing are a
source of microbial contamination due to the following reasons:
i. Inadequate training, Improper hygiene.
ii. Direct contact between the hands and starting materials, intermediate or
bulk products, primary packaging materials.
iii. Unauthorized personnel entering the production, storage areas.
iv. Insufficient gowning and protective equipment.
v. Eating, drinking or smoking within the storage and processing areas.
2) Raw Materials
i. Wrong labelling, Improper storage and handling.
ii. Incorrect sampling and testing.
iii. Microbial or chemical contamination.
iv. Degradation due to extreme environmental conditions like heat, cold,
sunlight, moisture etc.
20. 2
0
Mr. S. P. Shinde
3) Equipment and Utensils
i. Using defective equipment.
ii. Unsuitable design, size, corrosion causing materials.
iii. Inadequate cleaning and sanitisation.
iv. Adulteration with lubricants, coolants, dirt and sanitising agents.
v. Inefficient cleaning and maintenance due to their designing.
vi. Inappropriate calibration and irregular service.
4) Buildings and Facilities
i. Inadequate size and organization of the space.
ii. Poor pest controls.
iii. Rough floors, walls and ceilings.
iv. Absence of air filtration systems.
v. Poorly located vents, ledges and drains.
vi. Inadequate lighting and ventilation systems.
vii. Improper washing, cleaning, toilet, locker facilities, sanitary operation and
personal cleanliness.
Continue…
21. 2
1
Mr. S. P. Shinde
5) Manufacturing Process
i. Absence of facilities required for manufacturing of a single product.
ii. Improper cleaning between batches.
iii. Lack of cleaning status labelling on all equipment and materials used within
the manufacturing facility.
iv. Use of an open manufacturing system for exposing the product to the room
environment.
6) HVAC (Heating, Ventilation and Air Conditioning) System
HVAC system is a source of microbial growth and also disperses the contaminants
throughout the manufacturing unit.
i. Inadequate air filtration system.
ii. Materials accumulate in or near HVAC air intakes.
iii. Inadequate magnitude of pressure differentials, which causes flow of reversal.
iv. Incorrect ratio of fresh air to re-circulated air.
v. Incapability of accessing ventilation dampers and filtering from outside the
manufacturing areas.
vi. Non-directional airflow within production or primary packing areas.
Continue…
22. 2
2
Mr. S. P. Shinde
Methods of Prevention of Contamination
1) Personnel
They can take the following measures:
i. Personnel hygiene should be maintained and given proper and regular training
with respect to hygiene.
ii. Access to production areas by the unauthorized personnel should be restricted
and only trained person allowed to enter.
iii. Personnel entering the manufacturing area should wear protective clothing
such as over-garments, hair cover, beard or moustache cover and overshoes.
iv. Personnel should avoid touching with naked hands the exposed products or
any part of equipment.
2) Access to Areas
i. Access to production, packaging and QC areas by unauthorized personnel
should be restricted.
ii. Personnel should gain access to these areas only via changing rooms.
iii. Materials should be accessed via air locks route.
23. 2
3
Mr. S. P. Shinde
3) Facility Design
i. In aseptic rooms the differential air pressures should be higher than the
adjacent controlled areas.
ii. Air filtration, laminar air flow should be maintained.
iii. Ambient temperature and humidity should be maintained .
iv. The air pressure of the changing room should be negative with respect to the
manufacturing area corridor.
v. An impermeable barrier should be used in appropriate areas to prevent cross
contamination between two zones.
vi. HVAC air distribution components should be used for preventing the
spreading of contaminants generated within the room.
4) Utilities
i. Water of pharmaceutical grade, microbiologically controlled and monitored
should be used in the manufacturing of products.
ii. Clean and additive-free steam should be used for cleaning and sanitisation of
production tools and equipment.
Continue…
24. 2
4
Mr. S. P. Shinde
5) Building Requirements
i. Smooth, crack-free, easily cleanable floors, walls and ceilings should be used.
ii. Windows or viewing panels should be closed and sealed to prevent
accumulation of dust and microbial contaminants.
iii. The designing of pipe, ventilation and light points should be easily cleanable.
iv. Sinks of stainless steel should be present within the production areas.
6) Cleaning and Disinfection
i. Cleaning agents of proper grades should be used.
ii. The cleaning agents should not be directly applied on the product.
iii. Time-to-time cleanliness and disinfection of the areas should be done.
iv. Adequate hygiene should be maintained in every product manufacturing.
v. Contact time, application, temperature, mechanical action of cleaning agents
should be considered during the cleaning process.
Continue…
25. 2
5
Mr. S. P. Shinde
Clean Area Classification
❑ Clean room is a specially constructed enclosed area, which contains one or
more clean zones, where the concentration of airborne particles is controlled
using HEPA filters, continuous air circulation and a physical barrier to non
filtered air.
❑ Clean rooms establish appropriate environmental levels for airborne
particulates, temperature, humidity, air pressure and airflow patterns.
❑ Clean rooms are categorised by their constant air quality or class.
Clean Room Properties
Class 10,000
10,000 or less particles of 0.5μ and larger size exist in a
given cubic foot of air.
Class 1,000
1,000 or less particles of 0.5μ and larger size exist in a
given cubic foot of air.
Class 100
100 or less particles of 0.5μ and larger size exist in a given
cubic foot of air.
Table: Classes of Clean Rooms and their Properties
❑ Lower the classification number, cleaner is the air.
26. 2
6
Mr. S. P. Shinde
❑ Clean rooms are divided into different classes in standards. For
manufacturing sterile products, a certain classification with grades A to D
are characterised to activity category is used.
Grade
Maximum Permitted Number of Particles /m3
At Rest In Operation
0.5μm 5μm 0.5μm 5μm
A 3,520 20 3,520 20
B 3,520 29 352,000 2,900
C 352,000 2,900 3,520,000 29,000
D 3,520,000 29,000 Not defined Not defined
Table: Air Particle Classification System for the Manufacturing of Sterile Products
Continue…