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Laminar air flow by JIGNESH
Basic laboratory instruments
Principle and working of Laminar Air Flow
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The document discusses the management and use of laminar air flow for explant inoculation in tissue culture. It describes laminar air flow as an enclosed bench designed to provide sterile conditions through HEPA filtration and UV sterilization of air. Proper management includes sterilizing surfaces with ethanol before and after use, turning on UV lights 30 minutes prior, and flame sterilizing instruments. Explants are surface sterilized with mercuric chloride before trimming and inoculating into sterile culture media in the laminar flow hood. Inoculated cultures are then transferred to a sterilized culture room. Safety precautions for laminar flow use include switching off UV lights during use, cleaning hands with ethanol, and properly adjusting
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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.
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This document discusses laminar air flow hoods, including their purpose of providing sterile work environments, types (horizontal and vertical flow), working principles involving HEPA filtration of air, proper use and maintenance, and validation processes to ensure sterility through design, installation, operational, and performance qualifications. Laminar flow hoods use HEPA-filtered air flowing in a laminar pattern to maintain aseptic conditions for activities like cell culture work by removing airborne contaminants.
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Laminar air flow by JIGNESH
Basic laboratory instruments
Principle and working of Laminar Air Flow
In this ppt all infermation given
contact :
@instagram: mr.official.boy.jignesh
@twitter :910@jignesh
Laminar air flow
laminar air flow chamber is utilized for creating aseptic environment in laboratory conditions and have variety of uses
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The document discusses the management and use of laminar air flow for explant inoculation in tissue culture. It describes laminar air flow as an enclosed bench designed to provide sterile conditions through HEPA filtration and UV sterilization of air. Proper management includes sterilizing surfaces with ethanol before and after use, turning on UV lights 30 minutes prior, and flame sterilizing instruments. Explants are surface sterilized with mercuric chloride before trimming and inoculating into sterile culture media in the laminar flow hood. Inoculated cultures are then transferred to a sterilized culture room. Safety precautions for laminar flow use include switching off UV lights during use, cleaning hands with ethanol, and properly adjusting
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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.
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This document summarizes a dissertation report submitted by Ashish Diwakar on microbial limit testing conducted at IPCA Laboratories Ltd. in Ratlam, Madhya Pradesh, India. It provides an introduction to IPCA and the principles and requirements of microbial limit testing. Methods for total bacterial count, total fungal count, and testing for pathogens like E. coli, Salmonella, P. aeruginosa, and S. aureus are described. Both direct inoculation and membrane filtration methods are covered. Requirements include various culture media, glassware, and equipment. Test procedures and observations are outlined.
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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.
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This document discusses laminar air flow hoods, including their purpose of providing sterile work environments, types (horizontal and vertical flow), working principles involving HEPA filtration of air, proper use and maintenance, and validation processes to ensure sterility through design, installation, operational, and performance qualifications. Laminar flow hoods use HEPA-filtered air flowing in a laminar pattern to maintain aseptic conditions for activities like cell culture work by removing airborne contaminants.
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Evaluation of the efficiency of sterilization methods. Sterility indicators
Evaluation of the efficiency of sterilization methods. Sterility indicators
Sterility criteria: Bioburden ,Sensitivity of microorganisms
Death rate or Survivor curve,D- Value or Decimal reduction time,Z- value or Thermal reduction time, f- value, Q10 Value or Temperature Coefficient, Inactivation Factor:
STERILITY INDICATORS : Physical Indicators, Chemical Indicators
Biological Indicators
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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.
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This seminar discusses membrane filtration processes used for drug product sterilization. It introduces various types of membrane filtration including microfiltration, ultrafiltration, reverse osmosis, and gas separation. Validation of membrane filters is also covered, outlining testing for reproducibility, sterilization integrity, microbial challenges, and endotoxins. The presentation emphasizes that validation is necessary to ensure membrane filters consistently produce safe, effective products meeting quality standards.
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Microbial spoilage of pharmaceutical products can occur through various means. Physical, chemical, and microbial factors can all contribute to the deterioration of drugs and formulations. Contamination can enter at many points during the production process from personnel, facilities, equipment, materials, and manufacturing steps. Careful control is needed during all stages to minimize sources of spoilage and protect patient safety.
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- Hot air ovens circulate hot air to uniformly heat materials to high temperatures for extended periods of time, destroying microorganisms and bacterial spores through oxidation.
- Components include a heated inner chamber, motorized blower, temperature controls, and tray slots for materials.
- Hot air ovens are commonly used to sterilize glassware and materials in laboratories, as well as in various industries for drying, curing, and sterilization applications.
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This document provides information about clean rooms and aseptic areas. It defines clean rooms as rooms with controlled particulate and microbial contamination to minimize introduction of contaminants. Aseptic areas are designed to prevent microbial contamination of products during production. Sources of contamination include external sources like the air system as well as internal sources such as operators, equipment and raw materials. Different types of air flows and classifications of clean rooms are described. Key aspects of clean room design include air filtration and personnel protective clothing requirements.
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Killing or removing all forms of microbial life (including endospores) in a material or an object.
Mainly due to: oxidation of cell component, denature proteins, nucleic acids, RNA and loss of membrane permeability.
Procedures performed in a way to prevent contamination with infectious microorganisms
Used to prevent contamination of surgical instruments, medical personnel, and the patient during surgery
Sanitization: Lowering of microbial counts to prevent transmission in public setting (e.g., restaurants & public rest rooms)
Degerming: Mechanical removal of microbes from limited area. e.g., Alcohol swab on skin, washing of hands with soap
Sepsis: Bacterial contamination
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Tube Dilution Method.
Agar Plate Method.
Filter Paper & Cup Plate Method.
Ditch-Plate Method.
Phenol Coefficient Method.
The official phenol coefficient tests include,
Rideal-Walker Test (RW Test).
Chick-Martin Test.
United States FDA Test for Phenol Coefficient. (FDA Test)
The US Association of Official Agricultural Chemists Test (FDA Test)
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Kelsey Sykes Method
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Slides describe the definition, classification, factors affecting antimicrobial properties and various methods of evaluation of disinfectants.
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This document discusses disinfectants, providing information on their introduction, ideal characteristics, classification, modes of action, factors affecting disinfection, and methods of evaluation. It classifies disinfectants into nine main categories including acids, halogens, heavy metals, phenols, alcohols, aldehydes, quaternary ammonium compounds, dyes, and detergents/soaps. It also describes several common evaluation methods such as tube dilution, cup plate, gradient plate, and Kelsey-Sykes methods.
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Sterility criteria: Bioburden ,Sensitivity of microorganisms
Death rate or Survivor curve,D- Value or Decimal reduction time,Z- value or Thermal reduction time, f- value, Q10 Value or Temperature Coefficient, Inactivation Factor:
STERILITY INDICATORS : Physical Indicators, Chemical Indicators
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PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-V Part-1
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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
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v) Taste change
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Cracking of emulsion:
Odor changes
4. Biological spoilage:
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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.
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Scope of Pharmaceutical Microbiology
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Follow Atifa Ambreen:
Youtube: https://www.youtube.com/channel/UCVTn-4KeMtXKy1h3_9JbVmw
Facebook: https://www.facebook.com/atifaambreen786/
Instagram: https://www.instagram.com/atifa.ambreen/
https://www.instagram.com/invites/contact/?i=1qo1my1nb2qfx&utm_content=kbo8bi7
Snapchat: https://www.snapchat.com/add/atifa.ambreen
Twitter: https://twitter.com/atifa_ambreen
SUBSCRIBE ...
.
Email for inquiries: atifa.ambreen@gmail.com
Aseptic area
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.
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Microbial spoilage of pharmaceutical products can occur through various means. Physical, chemical, and microbial factors can all contribute to the deterioration of drugs and formulations. Contamination can enter at many points during the production process from personnel, facilities, equipment, materials, and manufacturing steps. Careful control is needed during all stages to minimize sources of spoilage and protect patient safety.
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This document describes a hot air oven project by Vedanti S. Gharat. It provides information on the working principles and components of a hot air oven, which uses dry heat to sterilize laboratory equipment and materials. Key points include:
- Hot air ovens circulate hot air to uniformly heat materials to high temperatures for extended periods of time, destroying microorganisms and bacterial spores through oxidation.
- Components include a heated inner chamber, motorized blower, temperature controls, and tray slots for materials.
- Hot air ovens are commonly used to sterilize glassware and materials in laboratories, as well as in various industries for drying, curing, and sterilization applications.
Design and operation of clean room PPT MANIK
This document provides information about clean rooms and aseptic areas. It defines clean rooms as rooms with controlled particulate and microbial contamination to minimize introduction of contaminants. Aseptic areas are designed to prevent microbial contamination of products during production. Sources of contamination include external sources like the air system as well as internal sources such as operators, equipment and raw materials. Different types of air flows and classifications of clean rooms are described. Key aspects of clean room design include air filtration and personnel protective clothing requirements.
Sterilization- Pharmaceutical Microbiology
Killing or removing all forms of microbial life (including endospores) in a material or an object.
Mainly due to: oxidation of cell component, denature proteins, nucleic acids, RNA and loss of membrane permeability.
Procedures performed in a way to prevent contamination with infectious microorganisms
Used to prevent contamination of surgical instruments, medical personnel, and the patient during surgery
Sanitization: Lowering of microbial counts to prevent transmission in public setting (e.g., restaurants & public rest rooms)
Degerming: Mechanical removal of microbes from limited area. e.g., Alcohol swab on skin, washing of hands with soap
Sepsis: Bacterial contamination
Antisepsis: Reduction or Inhibition of microbes found on LIVING TISSUE
Evaluation of Bactericidal and Bacteriostatic (Disinfectant). PHARMACEUTICAL ...
PHARMACEUTICAL MICROBIOLOGY (BP303T) Unit-III Part-5 Evaluation of Bactericidal and Bacteriostatic (Disinfectant). The common methods used for evaluation of a disinfectant are as follows,
Tube Dilution Method.
Agar Plate Method.
Filter Paper & Cup Plate Method.
Ditch-Plate Method.
Phenol Coefficient Method.
The official phenol coefficient tests include,
Rideal-Walker Test (RW Test).
Chick-Martin Test.
United States FDA Test for Phenol Coefficient. (FDA Test)
The US Association of Official Agricultural Chemists Test (FDA Test)
A. Rideal-Walker Test:
Kelsey Sykes Method
Disinfectants
Slides describe the definition, classification, factors affecting antimicrobial properties and various methods of evaluation of disinfectants.
Isolation And Preservation of Pure Baterial Culture
detail presentation on isolation methods for pure culture. also focused on preservation method of bacteria
Evaluation of disinfectant
The document outlines various methods used to test the efficacy of disinfectants, including carrier tests, suspension tests, and practical tests. Carrier tests involve contaminating a thread with bacteria and exposing it to disinfectants. Suspension tests measure a disinfectant's ability to kill bacteria suspended in its solution. Practical tests evaluate disinfectants under real-world conditions. The document also describes the phenol coefficient test, which compares a disinfectant's effectiveness to that of phenol, and the filter paper test, which detects zones of bacterial inhibition around treated disks.
Hot air oven instrument
A hot air oven uses dry heat between 150-250°C to sterilize items through conduction. Common sterilization times are 170°C for 30 minutes, 160°C for 60 minutes, or 150°C for 150 minutes. Items are sterilized as heat penetrates from the outside in, destroying cell constituents. Quality controls like Browne's tubes and spore strips ensure proper sterilization. While easy to use and non-toxic, dry heat takes longer than moist heat and may damage some materials.
Disinfectants
This document discusses disinfectants, providing information on their introduction, ideal characteristics, classification, modes of action, factors affecting disinfection, and methods of evaluation. It classifies disinfectants into nine main categories including acids, halogens, heavy metals, phenols, alcohols, aldehydes, quaternary ammonium compounds, dyes, and detergents/soaps. It also describes several common evaluation methods such as tube dilution, cup plate, gradient plate, and Kelsey-Sykes methods.
Preservation of pharmaceutical products - Pharmaceutical microbiology (Second...
Prof.Mr.Kiran K. Shinde (M.Pharm), Assistant professor (VNIPRC)
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Introduction
Preservatives using antimicrobial agent (Chemical Preservatives)
Factors Affecting Preservative efficacy
Evaluation of microbial stability of formulations
Microbiological assay-Principles and methods of different microbiological assay.
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Telstar produces the Pura range of sterility test isolators, which are designed to provide an aseptic environment for sterility testing of pharmaceutical products. The isolators undergo ergonomic testing during development to prevent issues. They utilize 3D modeling software during design. Telstar focuses on technical solutions and works with clients globally. The document then describes the ionHP bio-decontamination system used with the isolators and provides details on the various Pura isolator models.
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The document discusses Telstar's Pura range of sterility test isolators. It notes that ergonomic trials are performed early in development to prevent issues. The Pura range was developed using this process and 3D modeling software. Features of the Pura isolators include various chamber sizes, glove ports, materials suitable for hydrogen peroxide decontamination, and compliance with ISO standards for sterility testing. Benefits include reduced contamination risk and costs compared to traditional cleanrooms. Options include different decontamination systems and monitoring equipment.
Telstar Pura STI Brochure
The document discusses Telstar's Pura range of sterility test isolators. It notes that ergonomic trials are performed early in development to prevent issues. The Pura range was developed using this process and 3D modeling software. Features of the Pura isolators include various chamber sizes, glove ports, materials compatible with hydrogen peroxide sterilization, and options like monitoring sensors and shelving. The isolators are designed to avoid false positive sterility test results from contamination and provide a reliable aseptic environment.
Lab. operations
The document provides guidelines for designing and operating a microbiology laboratory. It discusses objectives for laboratory design which are to provide a safe environment for personnel and allow flexibility for research and teaching while anticipating health and safety hazards. Standards are outlined for containment of hazardous biological agents classified into four groups. Considerations for laboratory design include building design, internal structure and services, work flow, equipment used, and operation practices like documentation, standard operating procedures, and ensuring aseptic techniques.
Residential Air Purification Systems
This document provides information about residential air purification systems from IQAir. It discusses how IQAir focuses on air quality and testing their systems' actual performance, rather than just theoretical claims. It explains that IQAir's systems use multiple filtration stages including a pre-filter, gas and odor filter, and HyperHEPA filter to remove particles and pollutants down to 0.003 microns in size. The document highlights IQAir's three HealthPro models and their effectiveness for allergies, asthma, and indoor pollution, as well as their GC MultiGas model which is rated #1 for removing chemicals, odors, and smoke due to its four gas filter cartridges.
Medical-PPT
HI-TECH is an ISO certified Indian company that specializes in clean air and containment facilities for operating theaters. It prides itself on manufacturing high-quality products using the latest techniques to ensure reliability and long life. HI-TECH offers laminar airflow units, isolation rooms, and other modular operating theater equipment to help prevent infections in hospitals and meet various industry standards. It has numerous hospital and clinic customers throughout India that rely on its equipment.
Pilot plant scale up for parenteral dosage form
The document discusses the scale-up of parenteral dosage forms from the laboratory to a pilot plant and full-scale production facility. A pilot plant is an intermediate facility that transforms a laboratory formula into a robust product through developing a reliable manufacturing method. This allows issues to be identified and addressed before full-scale production. The pilot plant is used to evaluate how the process may be affected by a large scale change and to produce trial lots for examination. It helps minimize waste and maximize yield of the prescribed dosage form.
laminar flow equipment || Pharmaceutical Engineering || Anurag Gupta
Laminar flow equipment uses HEPA filters to maintain sterile conditions by removing airborne contamination. It works by passing air through a HEPA filter, which removes 99.97% of particles 0.3 um or larger. The filtered air then flows uniformly into the sterile working area at a laminar rate of 100 ft/min. There are two main types - horizontal laminar flow cabinets where the filtered air flows horizontally across the work area, and vertical laminar flow cabinets where the air flows vertically down onto the work area. Laminar flow equipment is used in laboratories, especially medical and pharmaceutical facilities, to provide a sterile environment for sensitive work.
GMP sterile products
TRAINING MODULE FOR IMPLEMENTATION OF GOOD MANUFACTURING PRACTICES FOR STERILE PRODUCT MANUFACTURING.
This training module is prepared based on (Annex 6. TRS 961, 2011) & readers are highly recommended to see this document in conjunction with Annex 6. TRS 961, 2011.
Air circulation
This document discusses air circulation maintenance in sterile and non-sterile pharmaceutical areas. It covers the importance of HVAC systems in maintaining air quality, including components like ducting, filters, and airflow patterns. Different classification systems are used for sterile versus non-sterile areas. HVAC systems can use either full fresh air or air recirculation with HEPA filters. Key parameters to monitor include filter integrity, air changes, pressure, microbial loads, temperature, and humidity. Proper air handling is crucial for pharmaceutical manufacturing to control contamination.
Aseptic technique for parenteral products
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.
Temperature & Humidity Control Chamber
Utopia produces temperature and humidity control chambers and test chambers that maintain appropriate conditions for critical environments like clean rooms. These chambers can accurately control temperature within a desired range and satisfy criteria for a variety of testing purposes in industries like automotive, construction, aerospace, and electronics. Utopia also provides walk-in chambers large enough to fit pallets for preconditioning and testing under different temperature and humidity conditions while monitoring tests. Additionally, Utopia supplies octagonal-shaped unidirectional filtering ceilings that reduce operating costs compared to square designs by around 20% through decreased surface area and air flow requirements.
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Laminar Air Flow
- 1. Laminar Air Flow Equipments in Singapore
- 2. Clean Rooms maintain particulate-free air through the use of either HEPA or ULPA filters employing laminar or turbulent air flow principles. Laminar, or unidirectional, air flow systems direct filtered air downward in a constant stream towards filters located on walls near the clean room floor or through raised perforated floor panels to be recirculated.
- 3. Laminar air flow systems are typically employed across 80% of a clean room ceiling to maintain constant air processing. Stainless steel or other non-shedding materials are used to construct laminar air flow filters and hoods to prevent excess particles entering the air.
- 4. Turbulent, or non-unidirectional, air flow uses both laminar air flow hoods and nonspecific velocity filters to keep air in a clean room in constant motion, although not all in the same direction. The rough air seeks to trap particles that may be in the air and drive them towards the floor, where they enter filters and leave the clean room environment.
- 5. Airtech is the leading manufacturer of clean room, Bio-safety and Operating Room equipment’s of high quality and meeting international standards of clean room technology, WHO Standard, GMP and Operating Room DIN standard.
- 6. Airtech Equipment Pte. Ltd. is established in the year 1984, from 2000 a Singapore joint venture between Utopia Aire Pte Ltd and Airtech Japan Ltd incorporated to manufacture unique and high quality Clean room, Bio-safety and Operating Room Equipment’s.
- 7. Airtech designs and Manufactures the clean room, Bio-safety and Operating Room equipment’s to customers requirement and also the products are be customized through professional design team for different industries.
- 8. Airtech product diversification will be able to meet the needs of different industries like Healthcare sterilize portable equipment , Hospital (PCR , Cytotoxic, Isolation, JCI, Tuberculosis (TB) Isolation mobile booth and ICU room), Laboratory & Bio safety lab (BSL1,BSL2 , BSL3, BSL4) and Semi-Conductors.
- 9. Airtech Equipment Pte Ltd Contact Us: 7 Kaki Bukit Place, Eunos Tech Park, Singapore - 416185 Tel : (65) 6746-6194 Fax : (65) 6747-0327 / 6746 4994 Email : info.airtech.biz@gmail.com Web : http://www.airtech.com.sg/ To Order Find Out More Information On Laminar Air Flow Please Come And Visit Us Today Onwards..!