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Microbiology Chart PDF

This document provides an overview of microbiology testing requirements for sterile and nonsterile pharmaceutical products. For nonsterile products, it outlines tests for microbial enumeration, absence of objectionable microorganisms, and alternative sampling methods. For sterile products, it discusses endotoxin limits, sterility tests, mycoplasma tests, aseptic processing, filtration, terminal sterilization methods and validation.

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0% found this document useful (0 votes)
321 views1 page

Microbiology Chart PDF

This document provides an overview of microbiology testing requirements for sterile and nonsterile pharmaceutical products. For nonsterile products, it outlines tests for microbial enumeration, absence of objectionable microorganisms, and alternative sampling methods. For sterile products, it discusses endotoxin limits, sterility tests, mycoplasma tests, aseptic processing, filtration, terminal sterilization methods and validation.

Uploaded by

seshadri
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Chart 10.

Microbiology

Nonsterile Products Sterile Products

Endotoxin Limits
Microbial Enumeration
<85> Bacterial Endotoxins Test
<61> Microbiological Examination of Nonsterile Products:
Microbial Enumeration Tests
Sterility Tests
<610> Alternative Microbiological Sampling Methods for
Nonsterile Inhaled and Nasal Products
<1111> Microbiological Examination of Nonsterile <71> Sterility Tests
Products: Acceptance Criteria for Pharmaceutical <1113> Microbial Identification, Characterization, and
Preparations and Substances for Pharmaceutical Use Strain Typing
<1208> Sterility Testing---Validation of Isolator Systems
<2021> Microbial Enumeration Tests---Nutritional and Dietary Supplements
<2023> Microbiological Attributes of Nonsterile Nutritional and Mycoplasma
Dietary Supplements

<63> Mycoplasma Tests


<1113> Microbial Identification, Characterization, and
Strain Typing
Absence of Objectionable
Microorganisms

<62> Microbiological Examination of Nonsterile Products:


Tests for Specified Microorganisms
<63> Mycoplasma Tests
<610> Alternative Microbiological Sampling Methods for
Nonsterile Inhaled and Nasal Products
<1111> Microbiological Examination of Nonsterile
Products: Acceptance Criteria for Pharmaceutical Aseptic Processing
Preparations and Substances for Pharmaceutical Use
<1113> Microbial Identification, Characterization, and <1113> Microbial Identification, Characterization, and
Strain Typing Strain Typing
<2022> Microbiological Procedures for Absence of Specified Microorganisms--- <1116> Microbiological Control and Monitoring of Aseptic
Nutritional and Dietary Supplements Processing Environments
<1208> Sterility Testing---Validation of Isolator Systems
Terminal Sterilization <1211> Sterilization and Sterility Assurance of Compendial Articles

<1222> Terminally Sterilized Pharmaceutical Products---Parametric Release Filtration


<1211> Sterilization and Sterility Assurance of Compendial Articles
Moist Heat

<55> Biological Indicators---Resistance Performance Tests Assembly


<1035> Biological Indicators for Sterilization
<1116> Microbiological Control and Monitoring of Aseptic
<1209> Sterilization---Chemical and Physicochemical Processing Environments
Indicators and Integrators
<1207> Sterile Product Packaging---Integrity Evaluation
<1211> Sterilization and Sterility Assurance of Compendial Articles

BFS
Dry Heat
<1116> Microbiological Control and Monitoring of Aseptic
<55> Biological Indicators---Resistance Performance Tests Processing Environments
<1035> Biological Indicators for Sterilization
<1211> Sterilization and Sterility Assurance of Compendial Articles FFS
<1116> Microbiological Control and Monitoring of Aseptic
Processing Environments
Radiation

<55> Biological Indicators---Resistance Performance Tests SFS


<1035> Biological Indicators for Sterilization <1116> Microbiological Control and Monitoring of Aseptic
<1211> Sterilization and Sterility Assurance of Compendial Articles Processing Environments

Other
EtO
<1072> Disinfectants and Antiseptics
<55> Biological Indicators---Resistance Performance Tests <1112> Application of Water Activity Determination to Nonsterile
<1035> Biological Indicators for Sterilization Pharmaceutical Products
<1116> Microbiological Control and Monitoring of Aseptic
<1209> Sterilization---Chemical and Physicochemical
Processing Environments
Indicators and Integrators
<1211> Sterilization and Sterility Assurance of Compendial Articles <1117> Microbiological Best Laboratory Practices
<1223> Validation of Alternative Microbiological Methods

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