Validation of steam sterilizer slideshare

Steam Sterilizer Views. Bio-Challenge studies shall use Bacillus stearothemophilus spore strips containing 10 6 or more spores per strip during the heat distribution studies. Bio-Challenge studies shall use Bacillus stearothemophilus spore strips containing 10 6 or more spores per strip during the heat penetration studies.

validation of steam sterilizer slideshare

Estimation of the F O value achieved during the sterilization hold period at each temperature-mapping probe. Connect the needle valve to the steam service pipe as shown in Figure NO.

If the tube is too short, copper or stainless steel tubing may also be used. Fill the container with cold water until it overflows.

Steam Sterilization PowerPoint PPT Presentations

Fill the burette and funnel with cold water, invert them and place them in the container. Draw out any air that has collected in the burette. With the steam sampling pipe out of the container, open the needle valve and allow steam to purge the air form the pipe. Place the pipe in the container, locate the end within the funnel, and add more cold water until it flows through the overflow pipe.

Place the empty measuring cylinder under the container overflow. Ensure that all the steam is discharged into the funnel and does not bubble out into the container. Note the setting of the needle valve. Close the valve.

Process Validation: Moist Heat Sterilization for Pharmaceuticals

Ensure that the container is topped up with cold water and that the measuring cylinder is empty. Draw out any air present in the burette. Ensure that the sterilizer chamber is empty except for the usual chamber furniture. Select and start the operating cycle. When the steam supply to the chamber first opens, open the needle valve to the previously noted setting, allowing a continuous sample of steam into the funnel sufficient to cause a small amount of steam hammer to be heard.

Allow the steam sample to condense in the funnel. Any non-condensable gases will rise to the top of the burette.Toggle navigation. Help Preferences Sign up Log in. Featured Presentations. Best known example is the membrane filter made from The items to be sterilized get completely surrounded by saturated steam Hanan Habib Dr.

Abdulaziz Al-Khattaf Definitions Sterilization: complete killing of all forms of microorganisms, including Sterilization - Khalifa Sifaw Ghenghesh Dept. Sterilization - Surgical Asepsis: The freedom of microorganisms before. Soak instruments in a Germicide solution according to Surgical Asepsis: The freedom of microorganisms before. Disinfectionsterilization, antibiotics - Sterilization or sterilisation refers to any process that eliminates, removes, kills, or deactivates all forms of life and other biological agents such as fungi, bacteria, viruses, spore forms, prions, unicellular eukaryotic organisms such as Plasmodium, etc.

Sterilization can be achieved through various means, including: heat, chemicals, irradiation, high pressure, and filtration. Sterilization is distinct from disinfection, sanitization, and pasteurization, in that sterilization kills, deactivates, or eliminates all forms of life and other biological agents which are present.

Sterilization or sterilisation refers to any process that eliminates, removes, kills, or deactivates all forms of life and other biological agents such as fungi, bacteria, viruses, spore forms, prions, unicellular eukaryotic organisms such as Plasmodium, etc. Plasma Sterilization - Plasma Sterilization Applications of plasmas for sterilization in medical, food processing, ventilating, and air conditioning industries Outline What is sterilization?

Plasma Sterilization Applications of plasmas for sterilization in medical, food processing, ventilating, and air conditioning industries Outline What is sterilization? All parenterals, as well as otic Can use softened feed water to decrease water hardness Boiler water is chemically treated to control pH levels What does the Plant Steam System Look Like? Global steam trap market is registering a substantial CAGR of 5.

Best Steam Cleaners - The steam cleaner is a floor cleaning tool with a sterilizing function. The steam cleaner dissolves the stubborn dirt adhering to the object through degree high-temperature steam for sterilization.

Steam cleaners are widely used for sterilization, dust removal, decontamination, and grease removal. The steam cleaner is a floor cleaning tool with a sterilizing function. Sterilization Standards JM Tech. Do-Young Ahn. Moist Heat Sterilization. For steam sterilization it is determined at a constant temperature.

The number of degree of temperature change necessary to change the D-value by a factor of The F value is a measurement of sterilization effectiveness. F T,z is defined as the equivalent time at temperature T delivered to a container or unit of product for the purpose of sterilization, calculated using a specific value of z. The term "Fo " is defined as the number of equivalent minutes of steam sterilization at temperature Sterilizer Cycle. Air pocket : too rapidly.

Diffusion into the steam : too slowly, more difficult to remove. Cycle Development. Bioburden studies : number of microorganisms. D-value studies : only highly resistant spore formers.

Sterilizer Validation

BIER biological indicator evaluator resistometer. Inoculate the spore into the actual solutions. For solid materials, precut strips. Preparing for Validation. Validation Protocol. Protocol should include. Heat Distribution Studies. Container Mapping. Heat Penetration Studies. Microbial Challenge Studies. Spore strips or spore suspension into the suspending medium. Validation Report. Maintenance of Validation. Controversial Issues.

Z-value measures the rate of change in the D-value as a function of temperature. Temperature uniformity of the heat distribution studies may be influenced by.Contact Information and Complete Document for Printing. For the purpose of ensuring sterility, all aqueous-based sterile products are subject to terminal moist heat sterilization, with the following exceptions: Instances where terminal moist heat sterilization is not practical, e. Such instances are fully evaluated and documented.

And for aseptic processes that exclude human intervention e. This document is intended to provide manufacturers of pharmaceutical dosage forms with guidance to establish the scientific effectiveness of moist heat sterilization processes, as required in Sections C.

The intent of this document is not to detail specific procedures or define elaborate mathematical principles which are critical to the validation process, as such information is readily available from other sources; rather, this guideline is intended as an outline of the elements in moist heat sterilization processes requiring evaluation, and describes approaches to effectively accomplish this goal in a manner which is acceptable to the HPFBI of Health Canada.

Other approaches which achieve equivalent results may also be acceptable. The section 17 of this guideline specifies the minimum documentation required to certify that moist heat sterilization processes have been thoroughly evaluated and are adequately controlled and validated.

Such documentation, aside from being invaluable to the manufacturer, is essential to the specialists of the HPFBI for the purpose of inspection and submission evaluation. This guideline is applicable to moist heat sterilization processes only.

While the principles outlined in this document are shared with other methods of sterilization, those processes require control and assessment of different parameters.

It must be recognized that, regardless of the sterilization process, the control of manufacturing environments and good manufacturing practices which provide barriers to microbial contamination remain of utmost importance. Drugs subject to terminal moist heat sterilization may be formulated in a grade C environment, provided that the formulated bulk is immediately subjected to its subsequent processing step, e.

Formulating may take place in a grade D environment if additional measures are taken to minimize contamination, such as the use of closed systems of manufacture.

validation of steam sterilizer slideshare

Parenterals are filled in an aseptic area of at least a grade B environment or in a grade A zone with at least a grade C background before terminal moist heat sterilization. Note: The limits for the microbial contamination and for the maximum number of particules, in the "at rest" and "in operation" states, in relation to different grades of air standards, are defined in the HPFBI Revised Guidance for section C.

The validation of moist heat sterilization processes may be performed using any of the three strategies outlined below. The approach selected should be appropriate and adequately supported. The studies are conducted, evaluated, and the process and equipment system certified prior to initiating routine production.

Concurrent validation studies are conducted during regular production and should only be considered for processes which have a manufacturing and testing history indicating consistent quality production. Reworks and failures indicate potential inconsistencies in the process and should be evaluated for effect on the reproducibility of production prior to establishing validation protocols.

Although suitable records may not be available for the installation of equipment, lack of this data may not compromise the balance of the studies. Normal processing records generally lack sufficient detail to permit retrospective validation. It must be established that the process was not modified and that the sterilizing equipment is operating under the same conditions of construction and performance as documented in the records to be considered.Validation of Pure Steam Learn how to validate the pure steam by testing non-condensable gases, steam dryness, pH, conductivity, microbial contamination and endotoxin tests.

Ankur Choudhary Print Question Forum 1 comment. Pure steam is used in various operations in pharmaceuticals but its use in sterilization is very common in pharmaceutical sterile manufacturing.

The pure steam system should be qualified. A WHO guide to good manufacturing practice GMP requirements- Part 2: Validation page clearly says to perform the performance qualification of pure steam. At the time of performance qualification of pure steam generation system, the sample shall be taken from each steam user point and analyzed for three consecutive days.

The purified water system must be qualified before starting the qualification of pure steam. Depyrogenated tubes or bottles should be used for taking the sample for bacterial endotoxin test.

Allow the steam to drain for minimum one minute. Open the cap of the bottle and fill the bottle with steam condensate by holding the bottle in the holder. Gloves should wear into the hands while sampling the pure steam. Tighten the cap of the bottle and mark with the sampling information. Analysis of Pure Steam: Pure steam should be analyzed for following tests. Non-condensable Gases: Non-condensable gases are air and carbon dioxide those do not condense with the steam.

These are generated due to their presence in the purified water that continuously circulates in the water distribution system. Non-condensable gases should not be more than 3. Steam Dryness Value: Dry steam has more energy than the wet steam. Wet steam has water with it and does not have heat energy as dry steam. Dryness of steam is determined by the latent heat.

High moisture content can cause the loss in energy of steam and that may cause the longer sterilization time. It should be between Conductivity should not be more than 1.

There should not any microbial contamination in the steam condensate. Pin it. Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since Sign-up for the free email updates for your daily dose of pharmaceutical tips.

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Provided by: MountSina5. Tags: heat sterilization. Latest Highest Rated. Denaturation of proteins e. Non-antimicrobial soap x2 Benzalkonium chloride and other quaternary ammonium compounds 0. Am J Infect Control. What do we mean by environment?

What is the right standard for clean? How do we measure adherence? How to assess risk of disease transmission to patients when there is a failure to follow recommended disinfection and sterilization guidelines Infect Control Hosp Epidemiol.

Whether your application is business, how-to, education, medicine, school, church, sales, marketing, online training or just for fun, PowerShow. And, best of all, most of its cool features are free and easy to use.Steam sterilization is one of the widely used and dependable methods of sterilization.

This mostly is meant to eradicate any living microorganisms in drug formulations, food materials, cosmetics etc.

validation of steam sterilizer slideshare

Presence of the microorganisms would act as contamination and possibly infect the person when those products are used. Steam sterilization is a type of moist heat method of sterilization done by using an instrument namely the autoclave. It is a very powerful method of sterilization as it can destroy microbes of all sorts from every nook and corner of the package.

As the name indicates, saturated steam is used as a sterilizing agent. It is formed due to boiling of the water at a temperature of degree centigrade.

The steam is in vapor form and is entrapped inside the autoclave without a chance of escape. Further, pressure is applied to help in formation of steam at lower temperature and also enhance penetration power. When the steam gets in touch with the material, it kills the organism by transferring the heat to the microbe. When the heat touches the microbe, the proteins and enzymes in the cells get coagulated and denatured instantly.

So the cell structure of the organisms gets destroyed leading to immediate death. Also when the steam transfers the heatit cools down and condenses to water. This creates a vacuum over the point of contact leading to further steam condensation at that point and more heat transfer.

Thus the rapid heat concentration on the microbes leads to their death without any possibility if escape. The autoclave is maintained at said temperature for suitable period of time. If the temperature increases, the time decreases and vice-verse. Biological indicators: The process is monitored by using biological indicators. A strip of spores of geobacillus thermophilus is used to check the validation of sterilization.

Steam Sterilization | Its Principle and Process Using Autoclave

Factors regulating the process include 1. Pressure: This helps to attain the desired temperature faster. Temperature:This provides the lethal potential to kill the microbes. Time: The contact time decides the extent of sterilization.

But it also varies as per other factors like temperature and pressure. Pros of steam sterilization: 1. It is applicable to wide range of substance like cotton, surgical equipment, nutrient media, water, liquid formulation etc. The time of sterilization is faster compared to filtration method and also hot air oven method. Besides bacteriaeven their spores dormant forms and toxins are destroyed.

The technique is less expensive as it relies on water and electricity for the process. Large scale sterilization can be done at a time.


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