EUROLAB
usp-2022-microbiological-testing-of-nonsterile-personal-care-products
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 SupplementsAOAC 966.23 Microbial Limits in CosmeticsEN 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 <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

USP <2022> Microbiological Testing of Nonsterile Personal Care Products: Laboratory Testing Services by Eurolab

Standard-Related Information

The United States Pharmacopeia (USP) is a non-profit organization that sets standards for the quality and purity of pharmaceuticals, dietary supplements, and personal care products. USP <2022> Microbiological Testing of Nonsterile Personal Care Products is a standard that outlines the requirements for microbiological testing of nonsterile personal care products.

Relevant Standards

The following international and national standards apply to USP <2022> Microbiological Testing of Nonsterile Personal Care Products:

  • ISO 11133:2014 Microbiology of food and animal feeding stuffs Preparation, enrichment, isolation, identification and maintenance of pure cultures

  • ASTM E1173-09 Standard Guide for Microbial Recovery from Materials

  • EN 1500:1997/A1:2009 Sterilization indicators - Particular requirements for the evaluation of sterilization processes using biological indicators

  • TSE 1085 (2012) Microbiological testing of nonsterile personal care products

    • Standard Development Organizations

    The standard development organizations involved in USP <2022> Microbiological Testing of Nonsterile Personal Care Products are:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Evolution of Standards

    Standards evolve over time to reflect new technologies, methodologies, and regulatory requirements. The USP <2022> standard was last revised in 2019 and is subject to periodic review and revision.

    Scope and Compliance Requirements

    The scope of USP <2022> Microbiological Testing of Nonsterile Personal Care Products applies to nonsterile personal care products that require microbiological testing. Compliance with this standard is mandatory for manufacturers and suppliers of these products.

    Standard-Related Industry-Specific Requirements

    The following industries require compliance with USP <2022> Microbiological Testing of Nonsterile Personal Care Products:

  • Cosmetics and personal care

  • Pharmaceuticals

  • Food and beverage

  • Medical devices

    • Standard Compliance Benefits

    Compliance with USP <2022> Microbiological Testing of Nonsterile Personal Care Products provides several benefits, including:

  • Improved product safety and quality

  • Enhanced customer confidence and trust

  • Compliance with regulatory requirements

  • Competitive advantage in the market

    • Standard-Related Technical Requirements

    The following technical requirements apply to USP <2022> Microbiological Testing of Nonsterile Personal Care Products:

  • Sampling procedures

  • Sample preparation

  • Testing methodologies

  • Data analysis and interpretation

    • ---

    Standard Requirements and Needs

    Why is USP <2022> Microbiological Testing of Nonsterile Personal Care Products Required?

    The microbiological testing of nonsterile personal care products is essential to ensure product safety and quality. This testing helps detect potential contaminants that can cause harm to consumers.

    Business and Technical Reasons for Conducting USP <2022> Microbiological Testing of Nonsterile Personal Care Products

    The business and technical reasons for conducting USP <2022> Microbiological Testing of Nonsterile Personal Care Products include:

  • To ensure product safety and quality

  • To comply with regulatory requirements

  • To build customer confidence and trust

  • To gain a competitive advantage in the market

    • Consequences of Not Performing this Test

    Failure to perform USP <2022> Microbiological Testing of Nonsterile Personal Care Products can result in:

  • Product recalls and withdrawals

  • Loss of customer confidence and trust

  • Damage to brand reputation

  • Financial losses

    • ---

    Test Conditions and Methodology

    Step-by-Step Explanation of the Test Conducted by Eurolab

    Eurolab conducts USP <2022> Microbiological Testing of Nonsterile Personal Care Products using the following steps:

    1. Sampling procedures

    2. Sample preparation

    3. Testing methodologies (e.g., viable counts, microbial identification)

    4. Data analysis and interpretation

    Testing Equipment and Instruments Used by Eurolab

    Eurolab uses state-of-the-art equipment and instruments to conduct USP <2022> Microbiological Testing of Nonsterile Personal Care Products, including:

  • Incubators

  • Microscopes

  • Spectrophotometers

  • Chromatography systems

    • Testing Environment Requirements

    The testing environment requirements for Eurolabs laboratory include:

  • Temperature control (25C 2C)

  • Humidity control (50 10)

  • Air pressure and flow control

  • Lighting and ventilation control

    • ---

    Test Reporting and Documentation

    How Test Results are Documented and Reported by Eurolab

    Eurolab documents and reports test results in accordance with USP <2022> Microbiological Testing of Nonsterile Personal Care Products, including:

  • Sampling procedures

  • Sample preparation

  • Testing methodologies (e.g., viable counts, microbial identification)

  • Data analysis and interpretation

    • Data Analysis and Interpretation

    Eurolabs data analysis and interpretation services include:

  • Calculation of microbial loads

  • Identification of microorganisms

  • Determination of antimicrobial efficacy

    • ---

    Conclusion

    USP <2022> Microbiological Testing of Nonsterile Personal Care Products is a critical standard that ensures the safety and quality of nonsterile personal care products. Compliance with this standard is mandatory for manufacturers and suppliers of these products. Eurolabs laboratory testing services ensure compliance with USP <2022> Microbiological Testing of Nonsterile Personal Care Products, providing customers with reliable and accurate results.

    ---

    Why Choose Eurolab for Your USP <2022> Microbiological Testing Needs?

    Eurolab is a leading provider of laboratory testing services for nonsterile personal care products. Our experienced team and state-of-the-art equipment ensure compliance with USP <2022> Microbiological Testing of Nonsterile Personal Care Products, providing customers with reliable and accurate results.

    Benefits of Choosing Eurolab

  • Compliance with regulatory requirements

  • Improved product safety and quality

  • Enhanced customer confidence and trust

  • Competitive advantage in the market

    • ---

    Contact Us

    For more information about our USP <2022> Microbiological Testing of Nonsterile Personal Care Products services, please contact us at:

    Email: infoeurolab.com(mailto:infoeurolab.com)

    Phone: 1 (800) 123-4567

    Address: Eurolab Inc., 123 Main St, Anytown, USA

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

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers