Sterility Testing

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Sterility Testing :

Sterility Testing Presented by :Miss. PRIYANKA VORA M.Pharm (Q.A) I ST SEM C.U.SHAH COLLEGE OF PHARMACY AND RESEARCH SURENDRANAGAR , GUJARAT-363001 By PresenterMedia.com

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Sterility Testing Content: Definition Principle of sterility testing Importance of sterility testing Objective Types of Indicator used in sterility testing Steps involves in sterility testing procedure:- A) Sampling B) Medium used in sterility testing C) Method of sterility testing i ) METHOD 1) Membrane filtration method ii)METHOD 2) Direct inoculation method D) Observation and interpretation Application of sterility testing in different dosage forms Interpretation and Repetition of test Result Sterility Assurance

DEFINITIONS: :

Sepsis: It is a serious medical condition characterized by whole body inflammatory state caused due to infection. Asepsis: It is an oppose of serious medical condition characterized by whole body inflammatory state caused due to infection. Sterilization :It is defined as the process which removes all the microorganisms from the preparation. Sterility : It means the absence of any form of viable microbes in specified area or product. Sterility Testing: It is a procedure carried out to detect and conform absence of any viable form of microbes in or on pharmacopeia preparation or product. DEFINITIONS:

Sterility Testing :

Sterility testing only shows that organisms capable of growing in selected conditions are absent from the fraction of batch that has been tested. Two conclusion can be drawn from this: 1) It cannot be used as sole means of controlling sterile processing. Aseptic can be controlled by careful supervision of operatives, regular air sampling and full-scale runs using nutrient broth. 2) To obtain reliable result it is necessary to take sufficient sample to use sensitive culture media and during testing to reduce accidental contamination a minimum Sterility Testing PRINCIPLE :

Sterility Testing:

Sterility Testing IMPORTANCE: Aseptically prepared Parenteralproduct cannot be issued with confidence unless control have been carried out to show that the risk of contamination is very low . For this purpose it is often used. PREPARATION TO BE TESTED FOR STERILITY applied to products intended to be sterile. (Ophthalmic and Parenteralpreparations , WFI, Catgut , Implant) Performed on random samples from the batch.

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OBJECTIVE OF STERILITY TESTING: For validation of sterilization process. To check presence of microorganisms in preparation which are sterile. To prevent issue of contaminated product in market. INDICATOR USED FOR STERILITY TESTING: INDICATORS are characterized preparation of a specific microorganism that provide a defined and stable resistance to specific sterilization process. CHEMICAL INDICATOR: e.g. Dichromate BIOLOGICAL INDICATOR: TYPE 1: spores that are added in disc , on filter paper, glass, plastic material etc. TYPE 2: Spore suspension TYPE 3: Self contain Indicator

STEPS INVOLVED IN STERILITY TE TESTING :

STEPS INVOLVED IN STERILITY TE TESTING Sampling 2) Medium used in sterility testing 3)Method of sterility testing i ) METHOD 1 Membrane filtration method ii) METHOD 2 Direct inoculation method 4) Observation and interpretation Must be carried out under aseptic condition.

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SAMPLING : Number of article to be tested It is known as sampling MAINLY FOLLOWED BY TWO RULES: A fixed percentage of the final container are selected. A fixed number of container are taken independent of the lot or batch size.

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Medium used in sterility testing Soyabean casein digest media: It is used to detect the growth of aerobic bacteria, but when incubated at 25 o C it will be suitable for the growth of fungi. Fluid thioglycolate: It is used to detect the growth of anaerobic bacteria, It also could be used to detect the growth of aerobic bacteria. It is anaerobic medium due to presence of: Sodium thioglycolate and cystaine which act as reducing agents. Small amount of agar to increase viscosity of the medium thus decreasing convection current. Redox indicator (MethyleneBlue) which change color of the medium when 30% of the medium become oxidized.

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Fluid thioglycolate: It should be prepared in long tube O 2 anaerobic bacteria aerobic bacteria Alternative fluid thioglycollate medium : same as FT medium but not contain agar and indicator Sabaroud’s dextrose medium: It is suitable medium used to detect the growth of fungi because: it has acidic pH. contains dextrose which is readily fermentable sugar.

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Incubation Condition IncubationTemperature: Incubate the media intended for detection of bacteria at 35oC. Incubate the media intended for detection of fungi at 25oC. Incubation Period: It should be not less than 7 days. Control tests : Performed exactly under the same condition as the test. Used to test the media used in the sterility test.

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Negative control: It is done by incubation of uninoculated tubes of each medium used in the test. It is done to test sterility of the medium. Control tests : Positive control: It is done to test incubation condition to show if the microorganism will actually grow under the condition of the test or not. 35 o C 35 o C 25 o C Thio TSB TSB Clostridium sporogenes Staph.aureus Candida albicans

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Methods of Sterility test Membrane Filtration: Suitable for samples with large volumes. Applied by: 1. Filtering the sample through a membrane filter. 2. Aseptically cut the membrane into three equal pieces. 3. inoculate them on appropriate culture media.

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Direct Inoculation: Suitable for samples with small volumes. Thio TSB TSB

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Application of Sterility test to Different Dosage Forms 1) Aqueous Solutions: Tested directly by direct inoculation method if it is of small volume or by membrane filtration method if it is of large volume. 2) Soluble Solids: Dissolve in a suitable solvent * Sterile. * Has no antimicrobial activity. Such as: meat peptone or caseine peptone Oily Preparations: Add a suitable emulsifying agent * Sterile* Has no antimicrobial activity. Such as: Polysorbate or Polyethoxyethanol. During incubation, oily preparation should be shaken gently every day.

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3)Ointments & creams: Dilute with a suitable diluent * Sterile * Has no antimicrobial activity. Such as: isopropyl myristate. add a suitable emulsifying agent. Application of Sterility test to Different Dosage Forms Antimicrobial agents (antibiotics & Preservatives) : Inactivate the inhibitory agent by either: 1. Dilution the preparation to less than MIC (Minimum Inhibitory Concentration) of the antimicrobial agent. 2. Addition of inactivating agent. For examples: addition of penicillinase solution to inactivate Sodium benzyl pencillin. Addition of Para amino benzoic acid (PABA) to inactivate sulphathiazole.

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Procedure: Using the Direct inoculation method. Carry out the control tests under the same condition of the experiment. Sterility Test for Water for Injection Thio TSB TSB 1ml 1ml 1ml

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Interpretation and Repeat Tests No contaminated units should be found A test may only be repeated when it can be demonstrated that the test was invalid for causes unrelated to the product being examined European Pharmacopoeia criteria (a) the data of the micro monitoring of the sterility test facility show a fault (b) a review of the testing procedure used during the test in question reveals a fault (c) microbial growth is found in negative controls (d) after determination of the identity of the microorganisms isolated from the test, the growth of this species or these species may be ascribed unequivocally to faults with respect to the material and/or technique used in conducting the sterility test procedure

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When conditions (a), (b) or (c) apply the test should be aborted If a stasis test performed at the end of the test shows no growth of challenge organisms, this also invalidates the test For conditions (d) to apply must demonstrate that the orgamisms isolated from the sterility test is identical to an isolate from materials (e.g. media) and/or the environment must use genotypic identification methods Repeat test is carried out with same number of samples as first test Any contamination detected in repeat test, product does not comply Results :- Any growth should be identified (genotypic) Automated/Semi-automated systems used for identification should be periodically verified using reference strains

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STERILITY ASSURANCE Established the process equipment Demonstrate the critical control for equipment/Instrument Perform replicate cycle for simulated product Monitor the validation process Complete the protocol and document STERILITY ASSURANCE ( Installation qualification stage ) Documentation Operation qualification stage Confirmatory stage Final stage

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RERERANCES :- Indian Pharmacopoeia’07 , govt. of India, ministry of health and welfare controller of publications , Delhi Vol-1,pg-52. 2) Cooper and gunn’s Dispensing for pharma ceutical students” CBS Publishers New Delhi,12 th edition pg-541. 3) U.S.P ‘07 4) ppt of Microbiological qulitycontrol by Dr. k.rao and by qulitycontrol guideline for sterility . 5) Text book of microbiology and biotechnology by kokare , sterility testing 3 rd edition .

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