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