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ISO 21322: 2020 – Microbiological risk assessment of Impregnated or Coated Wipes and Masks
ISO 21322 provides guidelines and test requirements for conducting microbial risk assessments of cosmetic products such as wipes and masks that are impregnated or pre-moistened with cosmetic ingredients for use on the skin, face, or other external applications.
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.
Cons
- Complexity – The detailed and specific procedures may be complex thus requiring high levels of expertise and resources to implement it correctly.
- Cost – Compliance with the standard could include considerable testing, equipment, and training costs, thereby placing a financial burden on some companies.
- Time-consuming – Processes like sample preparation, recovery of microorganisms, and enumeration, can be time-consuming thus slowing down product release times.
- Limited scope – It primarily focuses on microbiological testing and does not take into account other important aspects like chemical safety, toxicity, and environmental impacts.
- Potential for variability – While standardized methods are provided, variability in results can occur because of the differences in laboratory conditions, equipment, and expertise of personnel.
- Regulatory overlap – Multiple standards and regulations may increase complexity in ensuring compliance.
- Adaptation requirement – The need to adapt the methods for specific products or applications might require additional validation and verification efforts, adding to the complexity and workload for manufacturers.
At our facility, we employ state-of-the-art technology and methodologies to offer cosmetic 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.
At our facilities, we employ state-of-the-art technology and methodologies to offer testing services for a diverse range of cosmetic products. From impregnated/coated wipes and masks to lotion /creams to makeup products, we’ve got you covered. 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 frequently performed test methods 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.
FAQs
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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