ISO/TR 18811:2018
Cosmetics — Guidelines on the stability testing of cosmetic products
ISO/TR 18811:2018 gives guidelines for the stability testing of cosmetic products. It reviews readily available bibliographic references that provide a resource for the assessment of the stability of cosmetic products. This review of the available guidelines that assess the stability of cosmetic products can serve as a technical/scientific framework to identify the most suitable methods for the assessment of the stability of cosmetic products.
ISO/TR 18811:2018 does not aim to specify the conditions, parameters or criteria of stability testing.
Considering the wide variety of cosmetic products, storage and use conditions, it is not possible to define a single way to assess product stability. Therefore, it is up to the manufacturer to specify and justify the stability protocol to cover test methods, specifications and conditions at which products will be tested.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Basic principles of cosmetic stability
5 Aspects to be addressed during stability testing
5.1 General
5.2 Stage/scale of tested batches
5.3 Test procedures and conditions
5.3.1 Principle
5.3.2 Temperature and humidity
5.3.3 Cycling of temperature and/or humidity
5.3.4 Vibration
5.3.5 Centrifugation
5.3.6 Exposure to light (photostability)
5.4 Physical, physico-chemical and chemical alterations
5.4.1 Physical destabilization phenomena of different product types
5.4.2 Chemical destabilization processes
5.4.3 Destabilization phenomena
5.4.4 Specific test methods
5.5 Microbiological aspects
5.5.1 General
5.5.2 Microbiological parameters
5.5.3 Testing conditions
5.5.4 Microbiological specifications
5.5.5 Interpretation of results
5.6 Interaction with packaging
5.6.1 General information
5.6.2 Types of packing materials and main possible evaluations
5.6.3 Pressure vessels (aerosols)
6 Stability test conclusions
6.1 Evaluation
6.2 Report
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Basic principles of cosmetic stability
5 Aspects to be addressed during stability testing
5.1 General
5.2 Stage/scale of tested batches
5.3 Test procedures and conditions
5.3.1 Principle
5.3.2 Temperature and humidity
5.3.3 Cycling of temperature and/or humidity
5.3.4 Vibration
5.3.5 Centrifugation
5.3.6 Exposure to light (photostability)
5.4 Physical, physico-chemical and chemical alterations
5.4.1 Physical destabilization phenomena of different product types
5.4.2 Chemical destabilization processes
5.4.3 Destabilization phenomena
5.4.4 Specific test methods
5.5 Microbiological aspects
5.5.1 General
5.5.2 Microbiological parameters
5.5.3 Testing conditions
5.5.4 Microbiological specifications
5.5.5 Interpretation of results
5.6 Interaction with packaging
5.6.1 General information
5.6.2 Types of packing materials and main possible evaluations
5.6.3 Pressure vessels (aerosols)
6 Stability test conclusions
6.1 Evaluation
6.2 Report
Bibliography