EUROLAB
usp-1229-sterilization-of-compendial-articles
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 <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

USP <1229> Sterilization of Compendial Articles Laboratory Testing Service: A Comprehensive Guide

The United States Pharmacopeia (USP) <1229> Sterilization of Compendial Articles is a widely recognized standard for ensuring the sterility of pharmaceutical articles. This standard provides guidelines for laboratories to conduct sterilization testing, which is essential for maintaining product safety and efficacy.

Relevant Standards

The relevant standards governing USP <1229> Sterilization of Compendial Articles testing include:

  • ISO 11135:2009(E) Packaging industrially sterilized medical devices Requirements for validation and routine control

  • ASTM E1054-08 Standard Practice for Testing Steam Sterilizability of Healthcare Products

  • EN 556-1:2016 Medical devices Sterilization of medical devices intended solely for single use Requirements for validation and routine control

    • These standards provide a framework for laboratories to conduct sterilization testing, ensuring that products meet the required sterility levels.

    Legal and Regulatory Framework

    The USP <1229> Sterilization of Compendial Articles standard is part of the overall regulatory framework governing pharmaceuticals. Compliance with this standard is mandatory for manufacturers seeking to market their products in the United States. Failure to comply can result in severe consequences, including product recall, fines, and reputational damage.

    International and National Standards

    The International Organization for Standardization (ISO) develops standards that are adopted by countries worldwide. The ISO 11135 standard provides a framework for sterilization testing, while ASTM E1054-08 and EN 556-1:2016 offer specific guidelines for steam sterilization.

    Standard Development Organizations

    Standard development organizations play a crucial role in shaping the regulatory landscape. Eurolab is an international network of laboratories that promotes collaboration and knowledge sharing among its members. By participating in standard development, Eurolab contributes to the creation of globally recognized standards.

    Evolution of Standards

    Standards evolve over time as new technologies emerge and existing ones become outdated. Regular updates ensure that standards remain relevant and effective in ensuring product safety. The USP <1229> Sterilization of Compendial Articles standard is reviewed periodically to reflect changes in technology and industry practices.

    Compliance Requirements for Different Industries

    Compliance with the USP <1229> Sterilization of Compendial Articles standard is mandatory for manufacturers seeking to market their products in the United States. The following industries require compliance:

  • Pharmaceuticals

  • Biotechnology

  • Medical devices

    • Failure to comply can result in severe consequences, including product recall, fines, and reputational damage.

    The USP <1229> Sterilization of Compendial Articles standard is designed to ensure that pharmaceutical articles are sterilized effectively. The requirements for this testing include:

  • Sterilization Methods: Steam sterilization, ethylene oxide sterilization, and radiation sterilization

  • Validation Procedures: Biological indicator testing, chemical validation, and physical validation

  • Routine Control: Regular monitoring of sterilization processes to ensure consistency

    • Business and Technical Reasons for Conducting USP <1229> Sterilization of Compendial Articles Testing

    The business and technical reasons for conducting USP <1229> Sterilization of Compendial Articles testing include:

  • Ensuring product safety and efficacy

  • Maintaining regulatory compliance

  • Enhancing customer confidence and trust

  • Improving quality management systems and procedures

    • Consequences of Not Performing This Test

    Failure to conduct USP <1229> Sterilization of Compendial Articles testing can result in severe consequences, including:

  • Product recall

  • Fines and penalties

  • Reputational damage

  • Loss of market share and revenue

    • Industries and Sectors that Require This Testing

    The following industries and sectors require USP <1229> Sterilization of Compendial Articles testing:

  • Pharmaceuticals

  • Biotechnology

  • Medical devices

    • Failure to comply can result in severe consequences, including product recall, fines, and reputational damage.

    Risk Factors and Safety Implications

    The risk factors associated with non-sterile pharmaceutical articles include:

  • Bacterial contamination

  • Viral contamination

  • Mycotic contamination

  • Chemical contamination

    • These risks can result in serious health consequences for patients and damage to the reputation of manufacturers.

    Quality Assurance and Quality Control Aspects

    Eurolabs quality management system is designed to ensure that all testing services, including USP <1229> Sterilization of Compendial Articles testing, are performed with the highest level of accuracy and reliability. Our laboratory is accredited by international accrediting bodies and follows strict quality control measures to guarantee customer satisfaction.

    Competitive Advantages

    Performing USP <1229> Sterilization of Compendial Articles testing with Eurolab provides several competitive advantages:

  • Enhanced customer confidence and trust

  • Improved quality management systems and procedures

  • Compliance with regulatory requirements

  • Increased market share and revenue

    • Testing Service Details

    Eurolab offers a comprehensive range of USP <1229> Sterilization of Compendial Articles testing services, including:

  • Steam sterilization

  • Ethylene oxide sterilization

  • Radiation sterilization

  • Biological indicator testing

  • Chemical validation

  • Physical validation

    • Our experienced team will guide you through the testing process and provide detailed reports and certificates.

    Conclusion

    The USP <1229> Sterilization of Compendial Articles standard is a widely recognized standard for ensuring the sterility of pharmaceutical articles. Compliance with this standard is mandatory for manufacturers seeking to market their products in the United States. Eurolabs comprehensive range of testing services, including USP <1229> Sterilization of Compendial Articles testing, ensures that customers receive accurate and reliable results.

    Testing Services

    Eurolab offers a wide range of testing services, including:

  • Microbiological testing

  • Chemical testing

  • Physical testing

  • Biological testing

    • Our experienced team will guide you through the testing process and provide detailed reports and certificates.

    Contact Us

    For more information on our USP <1229> Sterilization of Compendial Articles testing services or to request a quote, please contact us:

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

    Phone: 1 800-123-4567

    Fax: 1 800-789-0123

    We look forward to collaborating with you and providing high-quality testing services.

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

    CONTACT US +902127020000

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