ISO 21322-2020 PDF

Full title and description

ISO 21322:2020 — Cosmetics — Microbiology — Testing of impregnated or coated wipes and masks. Guidance for the microbiological enumeration and/or detection of microorganisms in cosmetic products that are impregnated or coated onto substrates (for example wipes and sheet masks), addressing sampling, recovery and method selection where the product form presents particular testing challenges.

Abstract

This International Standard provides principles and practical guidance for selecting representative test samples, releasing and recovering microorganisms from substrates, choosing appropriate enumeration or detection methods (plate counts, membrane filtration, enrichment/detection), and validating neutralizers and recovery procedures for cosmetic products impregnated or coated onto substrates. The methods and principles can be adapted to similar product forms (cushions, applicators, impregnated sponges, etc.) with appropriate procedural modifications.

General information

• Status: Published (International Standard; stage reviewed — to be revised).
• Publication date: June 2020 (published 19 June 2020).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 07.100.40 (Cosmetics — microbiology).
• Edition / version: Edition 1 (First edition, 2020).
• Number of pages: 26.

Scope

ISO 21322:2020 gives guidance for the enumeration and/or detection of microorganisms present in cosmetic products that are impregnated into or coated onto a substrate (notably wipes and masks). It is intended for use where the product form complicates sampling and microbiological testing; the standard’s principles are applicable, with adaptation, to similar forms such as cushions, applicators and impregnated sponges. It covers selection of test sample, methods for release and recovery of microorganisms, choice of enumeration and detection techniques, use and validation of diluents/neutralizers and culture media, suitability testing and reporting of results.

Key topics and requirements

• Selection of representative test sample (whole-unit testing or defined Unit Item Portion, with weight recording).
• Choice of appropriate test method based on product form, packaging and expected bioburden (plate counts, membrane filtration, enrichment/detection).
• Procedures for releasing and recovering microorganisms from substrates (mechanical, chemical and neutralizing steps) and verification of recovery efficiency.
• Guidance on diluents, neutralizers and culture media to neutralize antimicrobial components and support recovery of viable organisms.
• Enumeration of aerobic mesophilic microorganisms and separate approaches for yeasts and moulds; options for spread/pour plate and membrane filtration methods.
• Enrichment/detection procedures for specified or indicator microorganisms where required by risk assessment or regulation.
• Suitability and validation testing (including neutralizer effectiveness and recovery validation) and related acceptance criteria.
• Expression, interpretation and documentation of results, including test report content and sample traceability.

Typical use and users

Used by cosmetic manufacturers for in‑house microbiological quality control and release testing of wipes, sheet masks and similar impregnated/coated products; contract and third‑party microbiology laboratories that perform bioburden and specified‑organism testing; regulatory and conformity assessment bodies reviewing microbiological test data; and R&D teams developing sampling and test procedures for new product forms.

Related standards

Standards commonly used alongside ISO 21322 include ISO 21149 (enumeration/detection of aerobic mesophilic bacteria), ISO 16212 (enumeration of yeasts and moulds), ISO 17516 (microbiological limits), ISO 11930 (evaluation of antimicrobial protection/preservation efficacy), ISO 18416 (detection of Candida albicans), ISO 29621 (microbiological risk assessment and identification of low‑risk products), and ISO 22716 (Good Manufacturing Practices for cosmetics). ISO 21322 has also been adopted as EN ISO 21322 in the European system.

Keywords

cosmetics; microbiology; wipes; sheet masks; impregnated products; coated substrates; bioburden; enumeration; detection; neutralizers; recovery validation; ISO 21322

FAQ

Q: What is this standard?

A: ISO 21322:2020 is an ISO International Standard providing guidance for microbiological testing of cosmetic products that are impregnated or coated onto substrates (for example wipes and masks).

Q: What does it cover?

A: It covers how to select representative samples, how to release and recover microorganisms from substrates, which enumeration and detection methods are suitable, how to choose and validate diluents/neutralizers and media, and how to document and interpret results.

Q: Who typically uses it?

A: Cosmetic manufacturers, contract testing laboratories, QC microbiologists, R&D teams and regulatory assessors working with impregnated or coated cosmetic product forms.

Q: Is it current or superseded?

A: It is the current first edition published in June 2020. The standard was published as an International Standard and its lifecycle indicates it is scheduled for periodic review.

Q: Is it part of a series?

A: It is part of the ISO cosmetics‑microbiology family of standards (ISO/TC 217) and is typically used together with related methods and guidance standards such as ISO 21149, ISO 16212, ISO 17516 and ISO 11930.

Q: What are the key keywords?

A: cosmetics, microbiology, wipes, masks, impregnated, coated, bioburden, enumeration, detection, neutralizer, validation, ISO 21322