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aoac-96623-microbial-limits-in-cosmetics
Sterility and Microbial Limit Testing 21 CFR Part 211.113 Control of Microbiological Contamination21 CFR Part 211.165 Testing and Release for Distribution21 CFR Part 211.167 Special Testing RequirementsAOAC 2003.01 Testing for Escherichia coli and ColiformsAOAC 2003.07 Microbial Enumeration for Nutritional SupplementsEN 556-1 Requirements for Medical Devices Labeled ‘Sterile’EN 556-2 Requirements for Sterile Barrier SystemsEN 868-1 Packaging Materials for Terminally Sterilized Medical DevicesEN 868-2 Sterilization WrapsEN 868-3 Paper for Use in SterilizationEN 868-4 Paper Bags for Steam SterilizationEN 868-5 Heat Sealable PouchesEN 868-6 Paper for Low Temperature SterilizationEN 868-7 Nonwoven WrapsEN 868-8 Reusable Textiles for Sterile Barrier SystemsEN ISO 11607-1 Packaging for Terminally Sterilized Medical Devices – RequirementsEN ISO 11607-2 Packaging Validation RequirementsEP 2.6.1 Sterility Testing of Finished Dosage FormsEP 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration TestsEP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified MicroorganismsFDA BAM Chapter 10 Listeria monocytogenes DetectionFDA BAM Chapter 14 Bacillus cereus TestingFDA BAM Chapter 18 Microbial Limits for CosmeticsFDA BAM Chapter 3 Aerobic Plate Count for Food and SupplementsFDA BAM Chapter 4 Enumeration of Yeast and MoldFDA BAM Chapter 5 Coliforms and E. coli DetectionFDA BAM Chapter 7 Staphylococcus aureus DetectionFDA BAM Chapter 8 Salmonella DetectionICH Q10 Pharmaceutical Quality SystemICH Q6A Specifications for New Drug SubstancesICH Q6B Specifications for Biotechnological ProductsICH Q7 GMP for Active Pharmaceutical IngredientsICH Q9 Quality Risk ManagementISO 11135 Validation of Sterilization by Ethylene OxideISO 11137-1 Sterilization of Healthcare Products – RadiationISO 11137-2 Establishing the Sterilization DoseISO 11137-3 Guidance on Dosimetric Aspects for Radiation SterilizationISO 11138-1 Biological Indicators – General RequirementsISO 11138-2 Biological Indicators for Ethylene Oxide Sterilization ProcessesISO 11138-3 Biological Indicators for Steam Sterilization ProcessesISO 11138-4 Biological Indicators for Dry Heat Sterilization ProcessesISO 11138-5 Biological Indicators for Low-Temperature Steam and FormaldehydeISO 11737-1 Bioburden Determination on Medical DevicesISO 11737-2 Tests of Sterility Assurance for Medical DevicesISO 13408-1 Aseptic Processing of Healthcare ProductsISO 13408-2 Sterilizing FiltrationISO 13408-3 Lyophilization for Aseptic ProcessingISO 13408-4 Clean-in-Place for Aseptic ProcessingISO 13408-5 Sterilization-in-PlaceISO 13408-6 Isolator Systems for Aseptic ProcessingISO 13408-7 Aseptic ConnectionsISO 14160 Sterilization of Medical Devices Using Liquid Chemical SterilantsISO 14644-1 Cleanroom Classification by Particle CountISO 14644-10 Classification of Surface Chemical CleanlinessISO 14644-2 Cleanroom Monitoring to Provide Evidence of CleanlinessISO 14644-3 Test Methods for CleanroomsISO 14644-4 Design, Construction and Start-Up of CleanroomsISO 14644-5 Operations in CleanroomsISO 14644-6 VocabularyISO 14644-7 Separative Devices (Clean Air Hoods, Gloveboxes, etc.)ISO 14644-8 Airborne Molecular ContaminationISO 14644-9 Classification of Surface Particle CleanlinessISO 14698-1 Biocontamination Control in Cleanrooms and Controlled EnvironmentsISO 14698-2 Evaluation Methods for Biocontamination ControlISO 14937 General Requirements for Sterilization ProcessesISO 15883-1 Washer-Disinfectors for Medical DevicesISO 15883-2 Washer-Disinfectors for Surgical InstrumentsISO 15883-3 Washer-Disinfectors for Human Waste ContainersISO 15883-4 Washer-Disinfectors for Thermolabile EndoscopesISO 15883-5 Test Soils and Methods for Washer-DisinfectorsISO 15883-6 Washer-Disinfectors for Baby Bottles and UtensilsISO 17665-1 Moist Heat Sterilization of Healthcare ProductsISO 17665-2 Guidance on Moist Heat Sterilization ValidationISO 18362 Manufacture of Sterile Medicinal ProductsJP 4.05 Sterility Testing for Injectable ProductsJP 4.06 Microbial Limit Tests for Pharmaceutical ProductsPDA TR 1 Sterility Testing GuidelinePDA TR 27 Pharmaceutical Package IntegrityPDA TR 28 Process Simulation TestingPDA TR 36 Isolator Systems for Sterility AssurancePDA TR 69 Bioburden and Cleanroom Microbial ControlPDA TR 70 Sterilization of Drug Products by Moist HeatPh. Eur. 2.6.30 Bacterial Endotoxins – LAL TestPh. Eur. 5.1.10 Guidelines for Viral Safety of Biotechnological ProductsPh. Eur. 5.1.2 Biological Indicators for Sterilization ProcessesPh. Eur. 5.1.4 Cleanroom and Isolator Environmental MonitoringPh. Eur. 5.1.6 Container Closure Integrity for Sterile ProductsPh. Eur. 5.1.8 Microbiological Quality of Herbal PreparationsTGA TG-GMP Sterility Requirements for Medicinal ProductsUSP <1211> Sterilization and Sterility AssuranceUSP <1222> Terminally Sterilized Drug ProductsUSP <1229> Sterilization of Compendial ArticlesUSP <1231> Water for Pharmaceutical PurposesUSP <2021> Microbiological Testing of Nutritional and Dietary SupplementsUSP <2022> Microbiological Testing of Nonsterile Personal Care ProductsUSP <55> Biological Indicators – Resistance Performance TestsUSP <61.1> Microbial Limit Testing for CosmeticsUSP <61> Microbial Enumeration Test for Non-Sterile ProductsUSP <62> Test for Specified Microorganisms in Pharmaceutical ProductsUSP <71> Sterility Test for Parenteral Drug Products

AOAC 966.23 Microbial Limits in Cosmetics Laboratory Testing Service: A Comprehensive Guide

Standard-Related Information

The AOAC 966.23 Microbial Limits in Cosmetics testing service is governed by a multitude of international and national standards that ensure the accuracy, reliability, and safety of the testing process. These standards are developed and published by various organizations, including:

  • International Organization for Standardization (ISO)
  • American Society for Testing and Materials (ASTM)
  • European Committee for Standardization (CEN)
  • Turkish Standards Institution (TSE)
  • These standards provide a framework for ensuring that the testing service meets the required quality, safety, and regulatory requirements. The main standards relevant to this testing service are:

    1. ISO 17025:2017 - General Requirements for the Competence of Testing and Calibration Laboratories

    2. ASTM E1059-18 - Standard Guide for Conducting an Interlaboratory Study to Evaluate the Precision of Analytical Methods

    3. CEN/TS 16640-1:2018 - Cosmetics - Microbiological requirements

    4. TSE EN ISO 11133:2017 - Cosmetic products - Microbiological requirements

    These standards dictate the testing methodology, sample preparation procedures, and measurement and analysis methods that must be used to ensure accurate and reliable results.

    The international and national standards applicable to this specific laboratory test are:

    1. ISO 11133:2014 - Microbiology of food, water, and feedstuffs - Preparation of test samples, initial suspension and decimal dilutions for microbiological examination

    2. ASTM E1355-19 - Standard Practice for Calculating Precision Statement

    3. CEN/TS 16640-1:2018 - Cosmetics - Microbiological requirements

    These standards provide a framework for ensuring that the testing service meets the required quality, safety, and regulatory requirements.

    The standard development organizations responsible for developing these standards are:

  • International Organization for Standardization (ISO)
  • American Society for Testing and Materials (ASTM)
  • European Committee for Standardization (CEN)
  • These organizations develop and publish new standards to ensure that they remain relevant and effective in ensuring the quality, safety, and regulatory compliance of laboratory testing services.

    Standard Requirements and Needs

    The AOAC 966.23 Microbial Limits in Cosmetics testing service is required by various industries and sectors due to the potential risks associated with microbial contamination in cosmetics products. The consequences of not performing this test can be severe, including:

    1. Product recalls: Failure to detect microbial contamination can lead to product recalls, which can result in significant financial losses for companies.

    2. Regulatory non-compliance: Failing to meet regulatory requirements can result in fines, penalties, and reputational damage.

    3. Consumer health risks: Microbial contamination can pose a risk to consumer health, leading to illnesses, injuries, or even fatalities.

    The industries and sectors that require this testing are:

    1. Cosmetics manufacturers

    2. Pharmaceutical companies

    3. Food and beverage manufacturers

    4. Dairy and animal feed industries

    The business and technical reasons for conducting AOAC 966.23 Microbial Limits in Cosmetics testing include:

    1. Ensuring product safety: The primary reason for conducting this test is to ensure that cosmetics products are safe for consumer use.

    2. Meeting regulatory requirements: This testing service ensures compliance with relevant regulations, laws, and standards.

    3. Protecting brand reputation: By ensuring that products meet quality and safety standards, companies can protect their brand reputation.

    Test Conditions and Methodology

    The AOAC 966.23 Microbial Limits in Cosmetics testing service involves the following steps:

    1. Sample preparation: The sample is prepared according to the relevant standard requirements.

    2. Testing equipment and instruments: The testing equipment and instruments used must meet the required standards, such as ISO 17025:2017.

    3. Testing environment requirements: The testing environment must be controlled to ensure accurate and reliable results.

    4. Measurement and analysis methods: The measurement and analysis methods used must be validated and calibrated according to relevant standards.

    The quality control measures during testing include:

    1. Calibration and validation procedures

    2. Quality control sample preparation

    3. Testing equipment and instrument calibration

    Test Reporting and Documentation

    The test results are documented and reported in a format that meets the required standards, such as:

  • ISO 17025:2017 - General Requirements for the Competence of Testing and Calibration Laboratories
  • ASTM E1355-19 - Standard Practice for Calculating Precision Statement
  • The report includes:

    1. Test results: The test results are presented in a clear and concise manner.

    2. Methodology used: The methodology used is described, including any deviations from the standard requirements.

    3. Quality control measures: The quality control measures taken during testing are documented.

    Certification and Accreditation

    The AOAC 966.23 Microbial Limits in Cosmetics testing service must be certified and accredited according to relevant standards, such as:

  • ISO/IEC 17025:2017 - General Requirements for the Competence of Testing and Calibration Laboratories
  • ASTM E1355-19 - Standard Practice for Calculating Precision Statement
  • The certification and accreditation process ensures that the testing service meets the required quality, safety, and regulatory requirements.

    Conclusion

    The AOAC 966.23 Microbial Limits in Cosmetics laboratory testing service is governed by a multitude of international and national standards that ensure the accuracy, reliability, and safety of the testing process. The consequences of not performing this test can be severe, including product recalls, regulatory non-compliance, and consumer health risks. The industries and sectors that require this testing include cosmetics manufacturers, pharmaceutical companies, food and beverage manufacturers, and dairy and animal feed industries. By following the required standards and guidelines, laboratories can ensure that they meet the necessary quality, safety, and regulatory requirements.

    Certification and Accreditation

    To become certified and accredited for the AOAC 966.23 Microbial Limits in Cosmetics testing service, laboratories must undergo a rigorous evaluation process that includes:

    1. Document review: Review of laboratory documentation, including policies, procedures, and standard operating procedures.

    2. On-site audit: An on-site audit to verify the laboratorys compliance with relevant standards and guidelines.

    3. Testing proficiency: Testing proficiency to ensure that the laboratory can accurately and reliably perform the required testing.

    Upon completion of the certification and accreditation process, laboratories will receive a certificate or accreditation document that confirms their competence in performing the AOAC 966.23 Microbial Limits in Cosmetics testing service.

    References

    1. International Organization for Standardization (ISO). (2017). General Requirements for the Competence of Testing and Calibration Laboratories (ISO/IEC 17025:2017).

    2. American Society for Testing and Materials (ASTM). (2019). Standard Practice for Calculating Precision Statement (ASTM E1355-19).

    3. European Committee for Standardization (CEN). (2018). Cosmetics - Microbiological requirements (CEN/TS 16640-1:2018).

    4. Turkish Standards Institution (TSE). (2017). Cosmetic products - Microbiological requirements (TSE EN ISO 11133:2017).

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