ISO 21148:2017
Cosmetics — Microbiology — General instructions for microbiological examination
ISO 21148:2017 gives general instructions for carrying out microbiological examinations of cosmetic products, in order to ensure their quality and safety, in accordance with an appropriate risk analysis (e.g. low water activity, hydro-alcoholic, extreme pH values).
Because of the large variety of products and potential uses within this field of application, these instructions might not be appropriate for some products in every detail (e.g. certain water-immiscible products).
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Premises
4.1 Test areas
4.2 Additional areas
4.3 Location of the premises
4.4 Equipping the premises
4.5 Maintenance
5 Equipment
5.1 General
5.2 Microbiological cabinets
5.3 Balances
5.4 Homogenizer
5.5 pH–meter
5.6 Autoclave
5.7 Incubator
5.8 Water baths
5.9 Refrigerator or cold-storage room
5.10 Freezer
5.11 Sterilizing oven
5.12 Colony-counting device
5.13 Other equipment
6 Strains of microorganisms
7 Personnel
7.1 Competence
7.2 Hygiene
8 Preparation of the apparatus and glassware
8.1 Preparation
8.2 Sterilization
8.2.1 Sterilization by dry heat
8.2.2 Sterilization by moist heat
8.3 Disposable apparatus
8.4 Management of clean apparatus and glassware
8.5 Management of sterile apparatus and glassware
8.6 Treatment of contaminated material
8.7 Washing
9 Preparation and sterilization of culture media and reagents
9.1 General
9.2 Water
9.3 Preparation of culture media
9.3.1 General
9.3.2 Rehydration
9.3.3 Measurement of pH
9.3.4 Dispensing
9.4 Sterilization
9.4.1 General
9.4.2 Sterilization by moist heat
9.4.3 Sterilization by filtration
9.5 Storage
9.5.1 General
9.5.2 Laboratory-prepared culture media and reagents
9.5.3 Ready-to-use culture media and reagents
9.6 Melting of agar culture media
9.7 Preparation of Petri dishes
10 Laboratory samples
10.1 General
10.2 Sampling the cosmetic product
10.3 Transport
10.4 Receipt and storage
10.5 Handling products and samples
10.6 Conservation and destruction of products
11 Operating practices
11.1 Hygienic precautions during the testing
11.2 Preparation of the initial suspension and of sample dilutions
11.2.1 General
11.2.2 Water-miscible product
11.2.3 Water-immiscible products
11.3 Counting methods
11.4 Detection methods
12 Expression of results
13 Neutralization of the antimicrobial properties of the product
Annex A (informative) Basic identification techniques
Annex B (informative) Basic techniques for counting and plating
Annex C (informative) Preparation and calibration of inoculums
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Premises
4.1 Test areas
4.2 Additional areas
4.3 Location of the premises
4.4 Equipping the premises
4.5 Maintenance
5 Equipment
5.1 General
5.2 Microbiological cabinets
5.3 Balances
5.4 Homogenizer
5.5 pH–meter
5.6 Autoclave
5.7 Incubator
5.8 Water baths
5.9 Refrigerator or cold-storage room
5.10 Freezer
5.11 Sterilizing oven
5.12 Colony-counting device
5.13 Other equipment
6 Strains of microorganisms
7 Personnel
7.1 Competence
7.2 Hygiene
8 Preparation of the apparatus and glassware
8.1 Preparation
8.2 Sterilization
8.2.1 Sterilization by dry heat
8.2.2 Sterilization by moist heat
8.3 Disposable apparatus
8.4 Management of clean apparatus and glassware
8.5 Management of sterile apparatus and glassware
8.6 Treatment of contaminated material
8.7 Washing
9 Preparation and sterilization of culture media and reagents
9.1 General
9.2 Water
9.3 Preparation of culture media
9.3.1 General
9.3.2 Rehydration
9.3.3 Measurement of pH
9.3.4 Dispensing
9.4 Sterilization
9.4.1 General
9.4.2 Sterilization by moist heat
9.4.3 Sterilization by filtration
9.5 Storage
9.5.1 General
9.5.2 Laboratory-prepared culture media and reagents
9.5.3 Ready-to-use culture media and reagents
9.6 Melting of agar culture media
9.7 Preparation of Petri dishes
10 Laboratory samples
10.1 General
10.2 Sampling the cosmetic product
10.3 Transport
10.4 Receipt and storage
10.5 Handling products and samples
10.6 Conservation and destruction of products
11 Operating practices
11.1 Hygienic precautions during the testing
11.2 Preparation of the initial suspension and of sample dilutions
11.2.1 General
11.2.2 Water-miscible product
11.2.3 Water-immiscible products
11.3 Counting methods
11.4 Detection methods
12 Expression of results
13 Neutralization of the antimicrobial properties of the product
Annex A (informative) Basic identification techniques
Annex B (informative) Basic techniques for counting and plating
Annex C (informative) Preparation and calibration of inoculums
Bibliography