Chart 10.

Microbiology
Nonsterile Products
Microbial Enumeration

Sterile Products
Endotoxin Limits
<85> Bacterial Endotoxins Test

<61> Microbiological Examination of Nonsterile Products:

Microbial Enumeration Tests
<610> Alternative Microbiological Sampling Methods for
Nonsterile Inhaled and Nasal Products
<1111> Microbiological Examination of Nonsterile
Products: Acceptance Criteria for Pharmaceutical
Preparations and Substances for Pharmaceutical Use
<2021> Microbial Enumeration Tests---Nutritional and Dietary Supplements
<2023> Microbiological Attributes of Nonsterile Nutritional and
Dietary Supplements

Sterility Tests
<71> Sterility Tests
<1113> Microbial Identification, Characterization, and
Strain Typing
<1208> Sterility Testing---Validation of Isolator Systems

Mycoplasma
<63> Mycoplasma Tests

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
Preparations and Substances for Pharmaceutical Use
<1113> Microbial Identification, Characterization, and
Strain Typing
<2022> Microbiological Procedures for Absence of Specified Microorganisms--Nutritional and Dietary Supplements

Terminal Sterilization
<1222> Terminally Sterilized Pharmaceutical Products---Parametric Release

<1113> Microbial Identification, Characterization, and

Strain Typing

Aseptic Processing
<1113> Microbial Identification, Characterization, and
Strain Typing
<1116> Microbiological Control and Monitoring of Aseptic
Processing Environments
<1208> Sterility Testing---Validation of Isolator Systems
<1211> Sterilization and Sterility Assurance of Compendial Articles

Filtration
<1211> Sterilization and Sterility Assurance of Compendial Articles

Moist Heat
<55> Biological Indicators---Resistance Performance Tests

Assembly

<1035> Biological Indicators for Sterilization

<1209> Sterilization---Chemical and Physicochemical
Indicators and Integrators

<1116> Microbiological Control and Monitoring of Aseptic

Processing Environments
<1207> Sterile Product Packaging---Integrity Evaluation

<1211> Sterilization and Sterility Assurance of Compendial Articles

Dry Heat
<55> Biological Indicators---Resistance Performance Tests

BFS
<1116> Microbiological Control and Monitoring of Aseptic
Processing Environments

<1035> Biological Indicators for Sterilization

<1211> Sterilization and Sterility Assurance of Compendial Articles

Radiation

FFS
<1116> Microbiological Control and Monitoring of Aseptic
Processing Environments

<55> Biological Indicators---Resistance Performance Tests

SFS

<1035> Biological Indicators for Sterilization

<1116> Microbiological Control and Monitoring of Aseptic

Processing Environments

<1211> Sterilization and Sterility Assurance of Compendial Articles

Other
EtO
<1072> Disinfectants and Antiseptics
<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

<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