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ISO 21322: 2020
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Quick understanding of the test
ISO 21322: 2020 - Microbiological risk assessment of Impregnated or Coated Wipes and Masks
- Staphylococcus aureus (ATCC 6538)
- Pseudomonas aeruginosa (ATCC 9027)
- Escherichia coli (ATCC 8739)
- Candida albicans (ATCC 10231)
- Bacillus subtilis (ATCC 6633)
- Differentiates between bacterial and fungal contaminants effectively.
- Ensures product safety and compliance with regulatory standards.
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Abstract
Purpose
ISO 21322 allows for the determination of microbial contamination in cosmetic products by analyzing test samples for the presence of viable microorganisms. Colonies of viable microorganisms are enumerated on a non-selective medium, and testing for specified microorganisms is done by media enrichment.
Products tested
- Impregnated or coated wipes – These are wipes that have been soaked with a liquid formulation.
- Masks – These are masks that have been coated or impregnated with a formulation.
Additionally, the principles and methods outlined in the document can also be applied to similar products, such as
- Cushions
- Impregnated sponges
- Applicators – This includes brushes, puffs, and other similar items.
Test organisms
The products must be tested against a range of microorganisms including Staphylococcus aureus (ATCC 6538), Pseudomonas aeruginosa (ATCC 9027), Escherichia coli (ATCC 8739), Candida albicans (ATCC 10231), and Bacillus subtilis (ATCC 6633).
Test method
- Sample preparation – 1g of the sample material is taken for testing. If one unit of the sample material weighs less than 1g, either the entire unit or multiple units can be used.
- Immersion – The test samples are immersed in a diluent.
- Microorganism separation – Test samples are subjected to techniques such as stomaching, shaking/stirring, or vortexing to separate microorganisms from the test sample. The frequency and speed of shaking/stirring are recorded.
- Enumeration – The enumeration of aerobic mesophilic microorganisms (including bacteria, yeasts, and molds) is performed using the pour plate technique. The diluent is divided for the separate enumeration of bacteria and yeasts/molds.
Importance of ISO 21322 test
Microbial contamination of cosmetic products occurs during the manufacturing phases due to unhygienic manufacturing, packaging, or storage practices. Thus, standardized microbial testing of impregnated or coated cosmetic products as per ISO 21322 guidelines is an essential part of the quality control and assurance to provide safe and high-quality products to consumers.
Pros and cons of ISO 21322
Pros
Comprehensive testing guidance
- Ensures adequate microbiological quality by detecting microorganisms in impregnated or coated products.
Specificity for product types
- Addresses microbiological sampling and testing challenges in products where the formulation is not directly accessible.
Standard test protocols
- Provides consistent and reliable testing methods across different laboratories and manufacturers.
Risk assessment
- Encourages appropriate microbiological risk assessments to help manufacturers identify and mitigate potential risks.
Improved product safety
- Increases consumer safety by ensuring products meet stringent microbiological standards.
Support for marketing claims
- Provides a basis for substantiating marketing claims about the microbiological efficacy of products.
Versatility
- The methods can be adapted for similar products and applicators other than wipes and masks.
Conclusion
At our facility, we employ state-of-the-art technology and methodologies to offer testing services for a diverse range of cosmetic products. Our cosmetic testing services are strictly adhered to industry standards and regulations. In addition to the ISO 21322 test method, ISO 21150 and ISO 21149 are other test methods that we perform in our labs.
Our dedicated team of experts works tirelessly to maintain the utmost accuracy in every aspect of our testing processes. To get a quote on ISO 21322 testing, contact our experts here.
Frequently Asked Questions
DR. Martinoz Scholtz
ISO 21322 is a test method used for determining microbial contamination of pre-moistened or impregnated cosmetic products such as wipes and masks.
This standard is an analytical test method that applies to impregnated cosmetic products like wipes and masks. The standard can also be adapted to test other products such as cushions, impregnated sponges, and applicators (brushes, puffs, and more).
This test takes 3-4 weeks to complete.
The standard does not provide the exact frequency of testing, but it is advisable to test your product during the initial product development phases and the final product stages.
Disinfectant wipes must be tested against a range of microorganisms including Staphylococcus aureus (ATCC 6538), Pseudomonas aeruginosa (ATCC 9027), Escherichia coli (ATCC 8739), Candida albicans (ATCC 10231), and Bacillus subtilis (ATCC 6633). Additional strains can be tested at the customer’s request.
While this test assesses the microbial contaminations in impregnated cosmetic products, it cannot vouch for the toxicity of the products. Thus, additional tests and international standards must be adopted to assess the toxicity of these products.
The standard ensures that the claims made by manufacturers regarding the microbial safety of cosmetic products are indeed true and are scientifically backed by test results. These test results can be used to obtain certifications for their products which provides the manufacturers with credibility during market entry.
Manufacturers must adhere to ISO 21322’s microbiological testing methods, conduct risk assessments, maintain accurate records of testing procedures, results, and suitability tests, and prepare documentation to demonstrate adherence to the standard.
Product developers wishing to ascertain higher levels of quality and safety for their products can use the microbiological testing methods set by this standard. This aids in identifying possible microbial contamination in early development phases, thus allowing them to make necessary changes to their formulations.
Non-compliance with the standard can lead to products failing to meet market standards, increased risk of recalls and consumer complaints, potential legal and financial repercussions, and damage to brand reputation and consumer trust.
Benefits of this standard include enhanced credibility, product safety assurance, competitive advantage, and reduced product recall risks and associated costs.
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