Microbiology

Biological Indicator For Heat Sterilisation

1 PARAMETERS OF BIOLOGICAL INDICATORS FOR HEAT STERILISATION 1-1 z-Value Sterilisation processes can be operated at temperatures lower than the standard 121 °C (for longer exposure times) or at higher temperatures (for shorter exposure times). The z-value (the temperature difference that leads to a 10-fold change in the D-value of the biological indicator) is used to compare the efficacy …

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Sterile Product Building, Facility and Clean Area Classification Guideline By USFDA

Sterile Product Building, Facility and  Clean Area Classification Guideline By USFDA has clearly mentioned what conditions to be followed to maintain the Sterile Conditions in Sterile Product Manufacturing site. 21 CFR 211.42(b) states, in part, that “The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings …

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Sterility Testing in Pharmaceutical Product as per USFDA Guideline

Sterility Testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. Sterility testing is very important for medical devices, pharmaceuticals, preparations, tissue materials and other materials that claim to be sterile or free from viable microorganisms. A. Method Suitability Test For all product types, follow current USP …

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Checklist for Microbiological Analytical Data and Reports

Checklist for review of microbiology data generated during the different tests of microbiology i.e. Antibiotic Assays, Particulate matter test, BET test, Preservative effectiveness testing ( Antimicrobial effectiveness testing), Microbial limit test (MLT), sterility, water analysis, and preservative effectiveness testing, Sterility testing. etc. Checklist for Microbiological Analytical Data and Reports Followings are the checkpoints during the …

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SOP For Microbial Culture Management

A microbial culture (microbiological culture) is a procedure of growing microbial organisms (reproduction) by allowing them to breed in programmed culture medium under controlled laboratory conditions. Microbial cultures are initial and basic diagnostic methods used as a research tool in molecular biology. Microbial Culture Management Standard Operating Procedure (SOP) PURPOSE: To lay down the procedure …

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