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iso-29621-microbiological-risk-assessment-for-low-risk-products
Microbiological Quality Testing AFNOR NF T73-101 Microbial Preservation Testing for CosmeticsANSM Challenge Testing of Natural Cosmetic FormulasANSM Microbiological Control of Non-Sterile Cosmetic ProductsANVISA RDC 481/2021 Microbial Control for Brazilian Cosmetic ProductsAOAC 2003.07 Challenge Test for Cosmetic CreamsAOAC 991.14 Microbial Contamination Detection in Personal Care ProductsAOAC 997.02 Microbial Quality of ToiletriesASTM D4014 Test for Microbial Growth on Lotions and CreamsASTM D5338 Biodegradation and Microbial Interaction in CosmeticsASTM D7983 Testing for Bacterial Endotoxins in Eye-area CosmeticsASTM E1326 Viable Organism Testing in Aerosolized Cosmetic ProductsASTM E2180 Antimicrobial Efficacy Testing of Preservative SystemsASTM E2275 Skin Antiseptic Residual Activity TestingASTM E2315 Time-Kill Assessment of Antimicrobial ActivityASTM E2613 Microbial Analysis of Water Used in CosmeticsASTM E2786 Biofilm Formation in Cosmetic Production EnvironmentsASTM E640 Bacterial Filtration in Cosmetic SpraysASTM F2101 Bacterial Filtration Efficiency of Cosmetic Face MasksCEN/TR 16953 Guidance on Application of ISO Microbial StandardsChina GB 7919 Microbial Limits in Non-Sterile CosmeticsChina GB/T 13531.1 Detection of E. coli in CosmeticsChina GB/T 13531.2 Detection of Pathogenic Bacteria in CosmeticsChina GB/T 13531.3 Microbial Limit in Baby ProductsCOLIPA Guideline for Preservation Efficacy TestingCOLIPA Microbiological Quality Assurance of Cosmetic ProductsEP 2.6.1 Sterility Test for Cosmetic Raw MaterialsEP 2.6.12 Total Aerobic Microbial Count TestingEP 2.6.13 Detection of Designated Microorganisms in CosmeticsEP 2.6.31 Validation of Microbiological Test Methods for CosmeticsEP 5.1.3 Evaluation of Preservative EffectivenessEP 5.1.4 Microbial Limits in Raw Cosmetic IngredientsEPA MB-17 Microbial Contamination Control in Natural FormulasFDA 21 CFR 211.113 Contamination Prevention Procedures for CosmeticsFDA 21 CFR 700.3 Microbial Contamination Limits in CosmeticsFDA BAM Chapter 14 Yeast and Mold Enumeration in Personal Care ProductsFDA BAM Chapter 23 Detection of Bacterial Pathogens in CosmeticsFDA CFSAN Guidelines for Cosmetic Microbiological SamplingFDA CPG Sec. 7120.01 Microbiological Criteria for Finished CosmeticsHealth Canada Compendial Test for Pathogenic Organisms in CosmeticsHealth Canada Cosmetic Microbiological Contamination GuidelinesIndia IS 14642 Microbial Contamination in Toiletries and SkincareIndia IS 4707-2 Cosmetic Ingredients Microbial AssessmentISO 11930 Microbiological Preservation Efficacy TestingISO 11932 Method Validation for Microbial Testing in CosmeticsISO 11989 Microbial Assessment of Eye CosmeticsISO 14502-2 Microbiological Testing of Polyphenol-Rich CosmeticsISO 16212 Quantification of Yeasts and Molds in Cosmetic ProductsISO 17516 Quantitative Limits of Microorganisms in Finished ProductsISO 18415 Detection of Specified and Non-Specified MicroorganismsISO 19007 Preservation Test of Microbial Resistance in Cosmetic WipesISO 21148 Detection of Anaerobic Bacteria in Cosmetic FormulationsISO 21149 Detection of Aerobic Mesophilic Bacteria in CosmeticsISO 21150 Detection of Escherichia coli in CosmeticsISO 22176 Hygiene Requirements in Cosmetic Packaging LinesISO 22716 Microbial Risk Management in GMP Cosmetic ManufacturingISO 22717 Identification of Pseudomonas aeruginosa in Cosmetic ProductsISO 22718 Identification of Staphylococcus aureus in CosmeticsISO 22719 Detection of Candida albicans in Cosmetic ProductsISO 24434 Enumeration of Aerobic Mesophilic Spores in Personal CareISO 24442 Selection Criteria for Challenge Test OrganismsISO/TR 19838 Guidance on Risk Management for Cosmetic MicrobiologyISO/TR 24444 Comparison of Microbiological Test ProtocolsISO/TR 24475 Microbiological Assessment of Cosmetic Raw MaterialsISO/TR 24476 Test Method Selection for Cosmetic Product MicrobiologyISO/TS 29621 Categorization of Cosmetic Products Based on Microbiological RiskJIS K 5101 Preservative Efficiency in Japanese CosmeticsJIS L 1902 Evaluation of Antibacterial Activity of Cosmetic TextilesJIS Z 2801 Antimicrobial Efficacy Testing for Surfaces in Cosmetic FacilitiesKFDA Microbiological Safety Evaluation of Korean Cosmetic ProductsKFDA Testing for Microbial Contamination in Imported CosmeticsPh. Eur. 2.6.12 Total Count Test for EmulsionsPh. Eur. 2.6.13 Detection of Pathogens in Powdered CosmeticsSCCS/1564/15 Risk Assessment of Microbiological Contamination in CosmeticsSCCS/1611/19 Safety Levels of Microbial Contaminants in CosmeticsTS 13218 Total Bacteria Count in Cosmetic CreamsTS 13531 Bacterial Safety Testing of Shampoo ProductsTS EN 12353 Hygiene Control of Cosmetic Containers and ClosuresTS EN ISO 11930 Preservative Efficacy Test for Personal Care ProductsTS EN ISO 16212 Mold and Yeast Count in Cosmetic LiquidsTS EN ISO 18415 Detection of Transient Organisms in ToiletriesTS EN ISO 21148 Enumeration of Microorganisms in Cosmetic ProductsUSP <1227> Validation of Microbial Recovery in Cosmetic ProductsUSP <1231> Water Quality for Microbiological Control in Cosmetic ProductionUSP <2021> Microbial Control of Nutraceutical-Cosmetic HybridsUSP <2022> Evaluation of Cosmetic Quality Control ProtocolsUSP <51> Antimicrobial Effectiveness Testing (Preservative Challenge Test)USP <61> Microbial Enumeration Testing for Non-Sterile CosmeticsUSP <62> Testing for Specified Microorganisms in CosmeticsUSP <791> pH Control and Microbial Growth AssessmentWHO Guidelines for the Microbiological Control of Herbal Cosmetics

Comprehensive Guide to ISO 29621 Microbiological Risk Assessment for Low-Risk Products Laboratory Testing Service Provided by Eurolab

ISO 29621 is an international standard that outlines the requirements for microbiological risk assessment of low-risk products. This standard is published by the International Organization for Standardization (ISO) and is widely recognized as a global benchmark for ensuring the safety and quality of products.

The legal and regulatory framework surrounding ISO 29621 Microbiological Risk Assessment for Low-Risk Products testing is governed by various national and international regulations, including:

  • EU Regulation No. 1935/2004 on Food Contact Materials

  • US FDAs Food Safety Modernization Act (FSMA)

  • Codex Alimentarius Commission (CAC) standards

    • These regulations mandate the use of microbiological risk assessment for low-risk products to ensure their safety and compliance with international standards.

    International and national standards that apply to this specific laboratory test include:

  • ISO 11133:2006 Microbiology of food, water and animal feeding stuffs Preparation, production, storage and performance testing of culture media

  • ASTM E2187-09 Standard Practice for Evaluation of the Linearity of Quantitative Measurement Methods

  • EN ISO 6611:2015 Microbiology of food and animal feeding stuffs Horizontal method for the detection and enumeration of Bacillus cereus in dried foods

  • TSE 1423:2018 Microbiological requirements for low-risk products

    • Standard development organizations, such as the International Organization for Standardization (ISO) and the American Society for Testing and Materials (ASTM), play a crucial role in evolving and updating standards to reflect changes in technology and regulatory requirements.

    Specific standard numbers and their scope are:

  • ISO 29621:2020 Microbiological risk assessment of low-risk products

    • Scope: This document provides guidelines for conducting microbiological risk assessments on low-risk products.

  • ASTM E2187-09 Standard Practice for Evaluation of the Linearity of Quantitative Measurement Methods

    • Scope: This standard specifies a method for evaluating the linearity of quantitative measurement methods.

    Standard compliance requirements vary by industry, but common requirements include:

  • Ensuring product safety and quality

  • Compliance with international regulations and standards

  • Demonstrating due diligence in risk assessment and mitigation

    • The specific test is needed to ensure the safety and quality of low-risk products. Business and technical reasons for conducting ISO 29621 Microbiological Risk Assessment for Low-Risk Products testing include:

  • Ensuring compliance with international regulations and standards

  • Demonstrating due diligence in risk assessment and mitigation

  • Protecting brand reputation and customer confidence

  • Preventing product recalls and associated costs

  • Meeting industry-specific requirements

    • Consequences of not performing this test include:

  • Non-compliance with regulatory requirements

  • Product contamination and recalls

  • Loss of customer trust and business reputation

  • Increased costs due to corrective actions

    • Industries that require ISO 29621 Microbiological Risk Assessment for Low-Risk Products testing include:

  • Food processing and manufacturing

  • Cosmetics and personal care products

  • Pharmaceuticals and medical devices

  • Consumer goods and household items

    • Risk factors and safety implications include:

  • Microbial contamination and growth on products

  • Spread of diseases and illnesses through product use

  • Economic losses due to product recalls and associated costs

    • Quality assurance and quality control aspects include:

  • Ensuring accurate and reliable testing results

  • Maintaining calibration and validation of testing equipment

  • Documenting testing procedures and results

  • Continuously improving testing methods and protocols

    • This test contributes to product safety and reliability by ensuring that products meet international standards for microbiological risk assessment. Competitive advantages of having this testing performed include:

  • Improved brand reputation and customer trust

  • Increased market share and sales due to compliance with regulations

  • Reduced costs associated with product recalls and corrective actions

  • Enhanced product quality and safety

    • The test is conducted in accordance with the guidelines outlined in ISO 29621. Testing equipment and instruments used include:

  • Microbiological analysis equipment, such as incubators and microscopes

  • Sampling equipment, including sterile swabs and containers

    • Testing environment requirements include:

  • Temperature control: 20-25C (68-77F)

  • Humidity control: 50-60

  • Air pressure control: atmospheric pressure

  • Lighting control: controlled lighting to prevent contamination

    • Sample preparation procedures include:

  • Collecting representative samples from the product

  • Sterilizing and storing samples in sterile containers

  • Transporting samples to the testing laboratory for analysis

    • Testing parameters and conditions include:

  • Microbiological analysis methods, such as enumeration and identification

  • Testing for specific microorganisms, including bacteria and fungi

  • Sampling and testing frequencies, depending on product type and risk level

    • Measurement and analysis procedures include:

  • Enumerating microbial populations using standard methods

  • Identifying microorganisms using biochemical or molecular techniques

  • Reporting results in accordance with ISO 29621 guidelines

    • Test results are interpreted based on the guidelines outlined in ISO 29621. Key factors to consider when interpreting test results include:

  • Microbial load: presence and quantity of microorganisms

  • Microbial identification: species-specific identification of microorganisms

  • Product safety: risk assessment and mitigation strategies

    • Risk assessment and mitigation strategies may include:

  • Implementing Good Manufacturing Practices (GMPs) and Sanitation Standard Operating Procedures (SSOPs)

  • Conducting regular microbiological testing and monitoring

  • Improving product design and formulation to reduce microbial growth

    • Conclusion

    ISO 29621 Microbiological Risk Assessment for Low-Risk Products is an essential standard for ensuring the safety and quality of low-risk products. By understanding the standard requirements, test conditions, and methodology, companies can ensure compliance with international regulations and standards, protect brand reputation, and prevent product recalls.

    Eurolabs laboratory testing services ensure accurate and reliable microbiological risk assessment results, providing customers with confidence in their product safety and compliance. Contact us today to learn more about our ISO 29621 Microbiological Risk Assessment for Low-Risk Products testing services.

    Appendix

  • List of relevant standards and regulations

  • Example test protocol and procedures

  • Glossary of key terms and definitions

    • Need help or have a question?
    Contact us for prompt assistance and solutions.

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