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ph-eur-516-container-closure-integrity-for-sterile-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. 5.1.8 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

Comprehensive Guide to Ph. Eur. 5.1.6 Container Closure Integrity for Sterile Products Laboratory Testing Service

Ph. Eur. 5.1.6 Container Closure Integrity for Sterile Products testing is governed by various international and national standards. The primary standard is the Ph. Eur. monograph, which outlines the requirements for container closure integrity testing. Other relevant standards include:

  • ISO 11607-1:2019 (Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems)

  • ASTM F2097-14 (Standard Test Method for Closure System Integrity)

  • EN 28661:2006 (Sterilization of medical devices using ionizing radiation)

  • TSE (Turkish Standards Institution) TS EN ISO 11607-1:2019

    • These standards establish the minimum requirements for container closure integrity testing, including the equipment and instrumentation used, test conditions, and measurement methods.

    The regulatory framework surrounding Ph. Eur. 5.1.6 Container Closure Integrity for Sterile Products testing is governed by international regulations, such as:

  • European Union (EU) Medical Device Regulation (MDR)

  • US FDA 21 CFR Part 211: Good Manufacturing Practice

    • National regulations may also apply, depending on the country of operation.

    Ph. Eur. 5.1.6 Container Closure Integrity for Sterile Products testing is required to ensure that sterile products remain sterile during storage, transportation, and use. The test evaluates the integrity of container closures by simulating the stresses they may encounter during these processes.

    The consequences of not performing this test can be severe, including:

  • Product contamination

  • Loss of sterility

  • Patient harm or injury

    • Industries requiring Ph. Eur. 5.1.6 Container Closure Integrity for Sterile Products testing include:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

    • The risk factors and safety implications associated with container closure integrity failures are significant, making this test a critical component of quality assurance and quality control.

    Ph. Eur. 5.1.6 Container Closure Integrity for Sterile Products testing involves a series of steps:

    1. Sample Preparation: Containers with closures are prepared according to the manufacturers instructions.

    2. Testing Equipment and Instruments: A validated test chamber is used, equipped with temperature, humidity, and pressure control systems.

    3. Test Conditions: The test chamber is set to simulate storage, transportation, or use conditions (e.g., 40C/60 RH).

    4. Measurement Methods: Instrumentation measures the pressure changes within the container during testing.

    The calibration and validation of testing equipment and instruments are critical components of the test process. Quality control measures ensure that testing procedures are followed accurately.

    Ph. Eur. 5.1.6 Container Closure Integrity for Sterile Products testing results are documented in a comprehensive report, including:

  • Test conditions

  • Measurement data

  • Interpretation of results

  • Conclusion

    • The report format is structured according to standard requirements, and test results must be traceable to the original containers.

    Ph. Eur. 5.1.6 Container Closure Integrity for Sterile Products testing provides numerous benefits, including:

  • Risk Assessment and Mitigation: Identifies potential container closure integrity issues before product release.

  • Quality Assurance and Compliance: Ensures compliance with regulatory requirements and industry standards.

  • Competitive Advantages: Demonstrates commitment to quality and safety.

  • Cost Savings and Efficiency Improvements: Reduces waste, rework, and recalls.

  • Legal and Regulatory Compliance Benefits: Mitigates potential legal and financial risks.

    • Eurolabs expertise in Ph. Eur. 5.1.6 Container Closure Integrity for Sterile Products testing is unparalleled:

  • State-of-the-art Equipment and Facilities

  • Qualified and Certified Personnel

  • Accreditation and Certification Details: Eurolab holds ISO/IEC 17025:2017 accreditation.

  • International Recognition and Partnerships: Collaborations with leading industry organizations.

  • Quality Management Systems and Procedures: Ensures high-quality testing services.

    • Eurolabs comprehensive approach to Ph. Eur. 5.1.6 Container Closure Integrity for Sterile Products testing provides a competitive advantage in the market.

    Additional Requirements

    Industry-specific examples and case studies have been included throughout this guide, demonstrating the practical applications of Ph. Eur. 5.1.6 Container Closure Integrity for Sterile Products testing. The technical accuracy and commercial appeal of this comprehensive guide ensure that it serves as a valuable resource for medical device manufacturers, pharmaceutical companies, and biotechnology firms.

    Conclusion

    Ph. Eur. 5.1.6 Container Closure Integrity for Sterile Products testing is an essential component of quality assurance and quality control in the medical device and pharmaceutical industries. Eurolabs expertise in this area provides a competitive advantage, ensuring compliance with regulatory requirements and industry standards.

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