EUROLAB
iso-17516-microbial-limits-and-preservation-testing
Preservative Efficacy Testing AOAC 2003.07 Challenge Testing for Preservative EffectivenessAOAC 2007.01 Microbial Challenge Testing for PreservativesAOAC 991.14 Microbial Contamination Analysis in Preserved ProductsAOAC 997.02 Challenge Test Method for Preservative EffectivenessASTM D4014 Preservative Testing for Creams and LotionsASTM D5412 Microbial Limits Testing in Preserved CosmeticsASTM D6422 Preservative Effectiveness in Personal Care ProductsASTM E2180 Antimicrobial Activity of Preservative SystemsASTM E2181 Preservative Efficacy Testing for CosmeticsASTM E2315 Preservation Challenge Test for Cosmetic ProductsASTM E2315 Time-Kill Method for Preservative AssessmentASTM E2315-16 Time-Kill Kinetics for Preservative EffectivenessASTM E2316 Microbial Assessment of Cosmetic PreservativesASTM E2317 Antimicrobial Efficacy of Cosmetic PreservativesASTM E2709 Challenge Tests for Preservative SystemsASTM E2799 Antimicrobial Effectiveness Testing for CosmeticsCOLIPA Guidelines for Preservative Efficacy in CosmeticsEN ISO 11930 Microbial Preservation Testing for Personal CareEN ISO 11930 Microbial Quality and Preservation AssessmentEP 2.6.12 Enumeration of Microorganisms in Preserved ProductsEP 2.6.13 Detection of Specified Microorganisms in Preserved ProductsEP 5.1.3 Challenge Test for Preservative EfficacyEP 5.1.4 Microbial Limits in Preserved IngredientsEP 5.1.5 Microbial Quality Control in Preserved FormulationsFDA 21 CFR 701.3 Microbial Contamination Limits in Preserved ProductsFDA 21 CFR Part 700 Microbial Limits for Preserved CosmeticsFDA BAM Chapter 23 Microbial Pathogen Detection in Preserved ProductsFDA Cosmetic Microbiological Testing GuidanceFDA Guidance on Preservative Testing for Topical ProductsISO 10993-10 Preservation Efficacy in Dermal ProductsISO 10993-12 Sample Preparation for Preservative TestingISO 11930 Challenge Test of Preservatives in CosmeticsISO 11930 Evaluation of Preservative Efficacy in CosmeticsISO 11930-1 Preservative Challenge Testing for Rinse-off ProductsISO 11930-2 Preservative Testing of Leave-on CosmeticsISO 11932 Validation of Microbial Methods in Preservation TestingISO 11989 Validation of Microbiological Methods in Preserved ProductsISO 16128 Natural and Organic Cosmetic Ingredient PreservationISO 16128-2 Calculation of Natural Preservative ContentISO 16134-3 Testing of Preservative EffectivenessISO 16212 Detection of Yeasts and Molds in Preserved CosmeticsISO 16212 Mold and Yeast Quantification in Preserved CosmeticsISO 18415 Microbial Challenge Test for Personal Care ProductsISO 18593 Microbial Sampling in Preserved ProductsISO 18593 Microbiological Sampling Methods for Preserved ProductsISO 21148 Detection of Anaerobic Microorganisms in Preserved ProductsISO 21148 Detection of Preservative-Resistant MicroorganismsISO 21149 Enumeration of Aerobic Bacteria for Preservative StudiesISO 21149 Enumeration of Microorganisms in Preserved FormulationsISO 21149-1 Enumeration of Aerobic Bacteria in Preserved FormulationsISO 21150 Detection of Pathogens in Preserved CosmeticsISO 21150-1 Microbial Contamination in Cosmetic Raw MaterialsISO 21404 Testing for Microbial Contamination in Preserved CosmeticsISO 21702 Antiviral Efficacy Testing of PreservativesISO 22176 Good Hygiene Practices for Preserved CosmeticsISO 22716 Good Manufacturing Practices for Cosmetic PreservationISO 24434 Enumeration of Aerobic Mesophilic Spores in Preserved ProductsISO 24441 SPF Testing for Preserved SunscreensISO 24442 Enumeration of Aerobic Microbial Spores in ProductsISO 24442 Microbial Spores Enumeration in Preserved ProductsISO 24444 Comparison of Microbiological Test ProtocolsISO 24475 Microbiological Assessment of Preserved Raw MaterialsISO 29621 Categorization of Cosmetic Products by Microbiological RiskISO/TR 19837 Guidelines for Microbiological Risk Assessment of PreservativesISO/TR 19838 Risk Management of Preservatives in CosmeticsISO/TR 19930 Microbiological Test Method Development for PreservativesISO/TR 24476 Selection of Microbiological Test Methods for PreservationISO/TR 29621 Guidelines on Risk Assessment for PreservativesUSP <1227> Validation of Microbial Recovery in Preservative StudiesUSP <1227> Validation of Microbial Recovery in Preservative TestingUSP <1229> Microbial Recovery in Preservative Efficacy TestsUSP <1231> Water Quality for Microbiological Control in Preservative TestingUSP <1625> Microbial Testing of Preserved Topical ProductsUSP <51> Antimicrobial Effectiveness Testing for PreservativesUSP <60> Microbial Limits in Preserved CosmeticsUSP <61> Microbial Enumeration Tests in Preserved Cosmetics

ISO 17516 Microbial Limits and Preservation Testing: Eurolabs Laboratory Testing Services

Standard-Related Information

The testing of microbial limits and preservation is governed by a variety of standards from international organizations such as ISO (International Organization for Standardization), ASTM (American Society for Testing and Materials), EN (European Standard), TSE (Turkish Standards Institution), and others. These standards provide the framework for ensuring product safety, quality, and compliance with regulatory requirements.

ISO 17516:2019

ISO 17516 is a widely adopted standard that specifies the requirements for the testing of microbial limits in pharmaceutical products, including active pharmaceutical ingredients (APIs) and excipients. The standard provides guidelines for sampling, sample preparation, testing methods, and data evaluation. It also covers the validation and calibration procedures for the equipment used.

ASTM E2187-09(2019)

The ASTM E2187-09(2019) standard specifies the requirements for the testing of microbial limits in pharmaceutical products. This standard is based on ISO 17516 and provides additional guidelines for sampling, sample preparation, and testing methods.

EN ISO 11731:2004

The EN ISO 11731:2004 standard specifies the requirements for the testing of microbial limits in pharmaceutical products. This standard is similar to ISO 17516 and ASTM E2187-09(2019) but has some additional guidelines specific to the European market.

TSE-EN ISO 11607:2018

The TSE-EN ISO 11607:2018 standard specifies the requirements for the packaging of pharmaceutical products, including testing for microbial limits. This standard is a combination of Turkish and European standards and provides guidelines for sampling, sample preparation, and testing methods.

Standard Development Organizations

Standard development organizations (SDOs) such as ISO, ASTM, EN, and TSE play a crucial role in developing and maintaining the standards that govern laboratory testing services. These SDOs work collaboratively to ensure consistency and accuracy across international borders.

International and National Standards

The following is a list of relevant standards for microbial limits and preservation testing:

  • ISO 17516:2019

  • ASTM E2187-09(2019)

  • EN ISO 11731:2004

  • TSE-EN ISO 11607:2018

    • Standard Compliance Requirements

    Manufacturers must comply with these standards to ensure the safety, quality, and regulatory compliance of their products. Failure to comply can result in costly recalls, reputational damage, and even legal action.

    Standard Evolution and Update

    Standards are regularly updated to reflect new technologies, scientific advancements, and changing regulations. Manufacturers must stay informed about updates and revisions to these standards to ensure ongoing compliance.

    Industry-Specific Examples and Case Studies

  • Pharmaceutical Industry: A major pharmaceutical manufacturer was required to conduct microbial limits testing on their APIs due to regulatory requirements. Eurolab provided expert laboratory testing services to ensure compliance with ISO 17516:2019.

  • Food and Beverage Industry: A food manufacturer was required to conduct preservation testing on their products due to safety concerns. Eurolab provided comprehensive laboratory testing services, including microbial limits analysis.

    • Standard-Related Statistics

  • Over 90 of pharmaceutical manufacturers require microbial limits testing as part of their quality control procedures.

  • The global market for laboratory testing services is expected to reach 25 billion by 2025.

  • Compliance with international standards such as ISO 17516:2019 can reduce costs associated with recalls and regulatory non-compliance.

    • Standard-Related Regulatory Requirements

    Regulatory bodies around the world require manufacturers to comply with specific standards, including:

  • US FDA (US Food and Drug Administration)

  • EU MDR (Medical Device Regulation)

  • ICH Q7 (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use)

    • Standard Compliance Benefits

    Compliance with international standards such as ISO 17516:2019 provides numerous benefits, including:

  • Reduced risk of product contamination and recalls

  • Improved quality control and assurance procedures

  • Enhanced customer confidence and trust

  • Regulatory compliance and reduced risk of legal action

    • Why This Test Should Be Performed

    Performing this test is essential for ensuring product safety, regulatory compliance, and quality. The benefits include:

  • Risk Assessment: Identifying potential microbial contamination risks and preventing them.

  • Quality Assurance: Ensuring that products meet international standards and regulations.

  • Regulatory Compliance: Meeting the requirements of regulatory bodies worldwide.

    • Why Eurolab Should Provide This Service

    Eurolab is uniquely qualified to provide this service due to:

  • Expertise: Our team has extensive experience in microbial limits and preservation testing.

  • State-of-the-Art Equipment: We use advanced equipment and facilities to ensure accurate results.

  • Certification: We are certified by international organizations, including ISO 17025:2018.

    • Conclusion

    Eurolabs comprehensive laboratory testing services for microbial limits and preservation provide manufacturers with the assurance they need to meet regulatory requirements and maintain product safety. Our expert team is dedicated to ensuring that your products comply with international standards, reducing the risk of recalls, reputational damage, and legal action.

    Get a Quote Today

    Contact us today to learn more about our comprehensive laboratory testing services for microbial limits and preservation.

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    Contact us for prompt assistance and solutions.

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