EUROLAB
iso-11607-1-package-integrity-for-sterile-medical-devices
Extractables and Leachables 21 CFR 174.5 General Requirements for Indirect Food Additives – E&L21 CFR 175.300 Resinous and Polymeric Coatings – Leachables Control21 CFR 176.170 Substances in Contact with Aqueous Foods – Extractables21 CFR 177.1520 Leachable Migration Limits for Polyolefins21 CFR 177.1630 Polyethylene Terephthalate Polymers – Leachables LimitASTM D6288 Volatile Organic Compounds Determination by GC/MSASTM D6499 N-nitrosamines Extraction from Rubber ComponentsASTM D7823 Screening of Phthalates in Plastic ComponentsASTM D7896 Analysis of Leachables in Water by LC-MS/MSASTM D8147 Non-Volatile Extractables in Polymeric MaterialsASTM E2406 Leachables from Sterile Barrier SystemsASTM F1980 Accelerated Aging for Stability of ExtractablesASTM F2459 Extractable Residue from Metallic Medical ComponentsASTM F3136 Evaluation of Leachables in Drug Delivery DevicesEMA Guideline on Plastic Immediate Packaging Materials – E&LEP 2.9.47 Container Closure System Integrity Testing for ExtractablesEP 3.1.3 Polyolefins in Contact with Injectable PreparationsEP 3.1.4 Polypropylene for Containers in ParenteralsEP 3.1.5 Polyethylene Used in Pharmaceutical ContainersEP 3.1.6 Polyethylene Terephthalate Containers – Leachable SafetyEP 3.2.2 Plastic Containers and Closures for Pharmaceutical UseEP 3.2.8 Closures for Containers for Aqueous Parenteral PreparationsEP 3.2.9 Rubber Closures – Extractables AnalysisEP 5.1.1 Biological Safety – Leachables Toxicity AssessmentFDA 21 CFR 211.94 Container Closure System Suitability – Extractables RiskFDA Guidance: Container Closure Systems for Drug Products – E&L FocusFDA Guidance: Orally Inhaled and Nasal Drug Products – Leachables ReviewHealth Canada GUI-0069 Plastic Components in Contact with Drug ProductsICH Q3D Risk-Based Assessment of Elemental Impurities in LeachablesISO 10993-12 Sample Preparation for Extractables TestingISO 10993-13 Degradation Products Analysis for Polymeric Medical DevicesISO 10993-14 Identification of Degradation Products from CeramicsISO 10993-15 Identification of Degradation Products from MetalsISO 10993-17 Toxicological Risk Assessment for LeachablesISO 10993-18 Chemical Characterization of Medical Device MaterialsISO 11607-2 Manufacturing Validation for Sterile Barrier SystemsISO 11979-5 Extractables in Intraocular Lens MaterialsISO 14937 Sterilization and Extractables Safety AssuranceISO 15759 Analysis of Packaging for Contact with Parenteral DrugsISO 17664 Processing of Leachable-Safe Reusable Medical DevicesISO 18562-1 Leachables Testing for Breathing Gas Pathways in HealthcareISO 18562-2 Volatile Organic Compounds Testing from Medical DevicesISO 18562-3 Condensate Leachables Testing from Gas Pathway EquipmentISO 18562-4 Leachable Particulates in Medical Gas Pathway DevicesISO/TR 10993-33 Guidance on E&L Assessment Strategy for DevicesJP 2.20 Extractables from Rubber Stoppers by GC-MSJP 6.02 Aluminum Cap Material Leachables TestingJP 6.07 Plastic Containers for Aqueous Injections – Leachable StandardsJP 6.10 Gas Permeability and Volatile Leachable ReleaseJP 7.02 Residual Solvent and Leachable IdentificationJP 7.04 Container/Closure Leachable Migration EvaluationPDA TR No. 66 Defining Leachables Risk in Biologics ProductionPDA TR No. 85 Extractables and Leachables in Manufacturing SystemsPh. Int. General Method 3.10 Leachable Profiling of Packaging MaterialsUSP <1031.1> Analytical Instrument Qualification for Extractables StudiesUSP <1031> Analytical Method Validation for Extractables StudiesUSP <1058> Analytical Instrument Qualification for Leachables TestingUSP <1079> Good Storage and Distribution Practices – Leachable RiskUSP <1086> Impurities – Extractables Risk ProfilingUSP <1088> Inhalation and Nasal Drug Products – Leachables TestingUSP <1207> Container Closure Integrity and Leachable EntryUSP <1231> Water for Pharmaceutical Purposes – Leachables RiskUSP <1661> Evaluation of Plastic Packaging Systems for Drug ProductsUSP <1663> Extractables Testing for Plastic Components in Drug PackagingUSP <1664> Leachables Analysis for Container Closure SystemsUSP <381> Elastomeric Closures for Injections: Extractable ProfileUSP <601> Aerosols – Extractables in Metered Dose InhalersUSP <661.1> Physicochemical Testing of Plastic Packaging SystemsUSP <661.2> Biological Reactivity Tests for Plastic MaterialsUSP <661> Packaging System Suitability for ExtractablesUSP <671> Stability and Buffering Capacity in Plastic ContainersUSP <800> Hazardous Drug Handling – Leachables from PackagingUSP <87> Biological Reactivity Test: In Vitro CytotoxicityUSP <88> Biological Reactivity Test: In Vivo Irritation & ToxicityUSP <905> Uniformity of Dosage Units – Leachable InfluenceWHO TRS 961 Annex 9 Guidelines on Packaging Materials – Leachables

Comprehensive Guide to ISO 11607-1 Package Integrity for Sterile Medical Devices Laboratory Testing Service

Standard-Related Information

ISO 11607-1 is an international standard that specifies the requirements for packaging systems designed to maintain the sterility of medical devices during storage and transportation. The standard is published by the International Organization for Standardization (ISO) and is widely adopted by regulatory authorities around the world.

The legal and regulatory framework surrounding this testing service is governed by various national and international standards, including:

  • ISO 11607-1:2016

  • ASTM F1938-16

  • EN 1667:2005

  • TSE (Turkish Standards Institution) 13551:2013

  • Other relevant standards from regulatory authorities such as the US FDA, European Medicines Agency (EMA), and Health Canada

    • These standards specify the requirements for packaging systems to maintain sterility during transportation and storage. The international standard development organizations, including ISO, ASTM, and EN, play a crucial role in developing and updating these standards.

    The scope of ISO 11607-1 includes:

  • Packaging systems designed to maintain sterility during transportation and storage

  • Medical devices that require packaging to maintain their sterility

  • Requirements for packaging systems to ensure the maintenance of sterility

    • Standard compliance requirements vary depending on the industry, but generally include:

  • Sterilization procedures

  • Packaging system design and testing

  • Validation and verification of packaging systems

  • Labeling and documentation requirements

    • Standard Requirements and Needs

    ISO 11607-1 Package Integrity for Sterile Medical Devices testing is required to ensure that medical devices are packaged in a manner that maintains their sterility during transportation and storage. This test is essential to prevent contamination and maintain product safety.

    Business and technical reasons for conducting this test include:

  • Prevention of contamination and product failure

  • Compliance with regulatory requirements

  • Ensuring product safety and reliability

  • Maintaining customer confidence and trust

    • Consequences of not performing this test include:

  • Product contamination and failure

  • Regulatory non-compliance

  • Loss of customer confidence and market share

    • Industries that require this testing include:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Healthcare organizations

    • Risk factors and safety implications associated with non-sterile packaging systems include:

  • Contamination of medical devices during transportation and storage

  • Patient harm or injury due to contaminated medical devices

  • Product failure and recalls

  • Regulatory non-compliance and fines

    • Test Conditions and Methodology

    The ISO 11607-1 Package Integrity for Sterile Medical Devices testing service involves the following steps:

    1. Sample preparation: Packaging systems are prepared according to the manufacturers instructions.

    2. Testing equipment: The test is conducted using a package integrity tester (PIT) or a similar device designed to simulate transportation and storage conditions.

    3. Testing environment: The test is performed in an environment with controlled temperature, humidity, and pressure.

    4. Measurement and analysis: The test results are measured and analyzed using specialized software.

    Test parameters include:

  • Temperature range (-20C to 40C)

  • Humidity range (10 to 80)

  • Pressure range (1 atm to 5 atm)

    • The testing timeframes and duration vary depending on the specific requirements of the medical device being tested. Sample size requirements are typically determined based on statistical considerations.

    Test Reporting and Documentation

    Test results are documented and reported in a clear and concise manner, including:

  • Test report format: The test report follows a standardized template that includes all relevant information.

  • Interpretation of test results: The test results are interpreted by qualified personnel to determine whether the packaging system meets the requirements of ISO 11607-1.

  • Certification and accreditation: The testing facility is accredited by recognized accrediting bodies, such as A2LA or NIST.

    • Electronic reporting systems used include:

  • Laboratory information management systems (LIMS)

  • Test result databases

  • Reporting software

    • Confidentiality and data protection measures are implemented to ensure the secure handling of customer data.

    Why This Test Should Be Performed

    The benefits and advantages of performing this test include:

  • Risk assessment and mitigation through testing

  • Quality assurance and compliance benefits

  • Competitive advantages and market positioning

  • Cost savings and efficiency improvements

  • Legal and regulatory compliance benefits

  • Customer confidence and trust building

    • Performing this test helps to prevent contamination, maintain product safety, and ensure compliance with regulatory requirements.

    Why Eurolab Should Provide This Service

    Eurolabs expertise and experience in this field make them an ideal choice for providing ISO 11607-1 Package Integrity for Sterile Medical Devices testing services. Their state-of-the-art equipment and facilities, qualified and certified personnel, and accreditation and certification details ensure that customers receive high-quality results.

    Additional benefits of choosing Eurolab include:

  • Turnaround time and efficiency advantages

  • Competitive pricing and value proposition

  • Technical support and consultation services

    • Eurolabs commitment to quality, customer satisfaction, and regulatory compliance makes them a reliable partner for medical device manufacturers seeking to maintain the sterility of their products during transportation and storage.

    Conclusion

    ISO 11607-1 Package Integrity for Sterile Medical Devices testing is an essential service that ensures the maintenance of sterility during transportation and storage. By performing this test, customers can prevent contamination, maintain product safety, and ensure compliance with regulatory requirements. Eurolabs expertise and experience make them an ideal choice for providing this service.

    References

    1. ISO 11607-1:2016 (International Organization for Standardization)

    2. ASTM F1938-16 (American Society for Testing and Materials)

    3. EN 1667:2005 (European Committee for Standardization)

    4. TSE (Turkish Standards Institution) 13551:2013

    5. US FDA, European Medicines Agency (EMA), and Health Canada regulations

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