BIOLOGICAL

Test(s)

Reference Method(s)

Harmonized Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests

USP/NF, Current Revision Chapter [61]
EP: Current Revision, Chapter 2.6.12

Pour Plate Method
Surface Spread Method
Filtration Method

Harmonized Microbiological Examination of Non-Sterile Products: Suitability of Counting Method

USP/NF, Current Revision Chapter [61]

Pour Plate Method
Surface Spread Method
Filtration Method

Harmonized Microbiological Examination of Non-Sterile Products: Suitability of the
Tests for Specified Microorganisms

USP/NF, Current Revision Chapter [62]

Heterotrophic Plate Count

SMEWW Part 9000 – Section 9215 A & B, 20^th ed., Pp 9-34 – 9-38
APHA/AWWA/WPCF, 1998

Filtration
Pour Plate

Harmonized Microbiological Examination of Non-Sterile Products: Tests for Specified Microorganisms

USP/NF, Current Revision Chapter [62] EP: Current Revision, Chapter 2.6.13

Presence/Absence Test for:

Bile Tolerant Gram-Negative Bacteria

Candida albicans

Clostridia

Escherichia coli

Pseudomonas aeruginosa

Salmonella spp.

Staphylococcus aureus

Test(s)

Reference Method(s)

Preservative Efficacy Testing Enumeration

USP/NF, Current Revision, Chapter [51]

Pour Plate
Membrane Filtration

EP; Current Revision, Chapter 5.1.3

Validation of Preservative System
Neutralization Plate Count

USP/NF, Current Revision, Chapter [1227]

Pour Plate
Membrane Filtration

CHEMICAL

Test(s)

Reference Method(s)

Total Organic Carbon Test

USP/NF, Current Revision, Chapter [643]
APHA/AWWA/WPCF, 1995

MECHANICAL

Test(s)

Reference Method(s)

Resistance of Opening by Children and
Accessibility by Senior Adults (Child Resistant Packaging) *

Code of Federal Regulations, 1700.20,
Requirements for the Special Packaging of Household Substances (July 21, 1995) using Behavioral Research Techniques

Resistance of Opening by Children and
Accessibility by Senior Adults (Child Resistant Recloseable Packaging) *

ISO 8317:2015, using Behavioral Research Techniques

Resistance of Opening by Children and Accessibility by Senior Adults (Child Resistant,
Non-recloseable, Pharmaceutical Packaging) *

ISO 14375:2018 using Behavioral Research Techniques

Abbreviations:

USP

United States Pharmacopeia

NF

National Formulary

EP

European Pharmacopeia

SMEWW

Standard Methods for the Examination of Water and Wastewater

EN

European Normalization