EUROLAB
iso-11607-2-manufacturing-validation-for-sterile-barrier-systems
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 11607-1 Package Integrity for Sterile Medical DevicesISO 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 11607-2 Manufacturing Validation for Sterile Barrier Systems Testing Services Provided by Eurolab

ISO 11607-2 is a standard that governs the manufacturing validation of sterile barrier systems, specifically medical packaging materials and systems. This standard is part of the larger ISO 11607 series, which covers the entire range of packaging materials and systems for medical devices.

Overview of Relevant Standards

  • ISO 11607-1:2016 - Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems

  • ISO 11607-2:2019 - Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and testing processes

  • ASTM F2095 - Standard Guide for the Design of Closed Systems Used in Sterilization by Moist Heat (e.g., Autoclave)

  • EN 868-1:2000 - Sterile barrier systems for single-use medical devices - Requirements

  • TSE 2025:2013 - Packaging Materials and Systems for Medical Devices

    • Legal and Regulatory Framework

    The legal and regulatory framework surrounding ISO 11607-2 is complex and varies by country. In the European Union, for example, manufacturers of medical devices must comply with EU regulations (e.g., MDR, IVDD) which reference ISO standards, including ISO 11607-2.

    International and National Standards

    ISO 11607-2 is an international standard developed by the International Organization for Standardization (ISO). However, many countries have their own national standards that reference or align with ISO 11607-2. For example, in the United States, ASTM F2095 provides similar requirements for sterilization of medical devices.

    Standard Development Organizations

    The development and maintenance of international standards like ISO 11607-2 are carried out by standard development organizations (SDOs). These SDOs include:

  • International Organization for Standardization (ISO)

  • American National Standards Institute (ANSI) in the United States

  • European Committee for Standardization (CEN) in Europe

    • Standard Evolution and Updates

    Standards like ISO 11607-2 evolve over time to reflect changes in technology, regulatory requirements, or industry best practices. This may involve updating existing standards or developing new ones.

    Specific Standard Numbers and Scope

    ISO 11607-1:2016 - Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems

    ISO 11607-2:2019 - Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and testing processes

    Standard Compliance Requirements

    Compliance with ISO 11607-2 is a requirement for manufacturers of medical devices that use sterile barrier systems. This includes compliance with the standards requirements for material selection, system design, testing, and validation.

    ---

    Why ISO 11607-2 is Needed

    The need for ISO 11607-2 arises from the critical importance of ensuring that sterile barrier systems are designed and manufactured to prevent contamination, ensure product sterility, and maintain packaging integrity throughout the sterilization process.

    Business and Technical Reasons for Conducting ISO 11607-2 Testing

    Conducting ISO 11607-2 testing is essential for several business and technical reasons:

  • Ensuring compliance with regulatory requirements

  • Maintaining product safety and reliability

  • Preventing costly recalls or product failures

  • Enhancing brand reputation and customer trust

    • Consequences of Not Performing this Test

    Not performing ISO 11607-2 testing can have serious consequences, including:

  • Non-compliance with regulations, leading to fines or penalties

  • Product contamination or sterility failure, resulting in harm to patients or customers

  • Loss of market share due to lack of product safety and reliability

    • Industries and Sectors that Require this Testing

    The following industries and sectors require ISO 11607-2 testing:

  • Medical device manufacturers (e.g., pharmaceuticals, surgical instruments)

  • Packaging material suppliers

  • Sterilization equipment manufacturers

  • Hospitals and healthcare institutions

    • Risk Factors and Safety Implications

    ISO 11607-2 testing identifies potential risk factors associated with sterile barrier systems, including:

  • Contamination or sterility failure

  • Packaging material degradation or failure

  • Sterilization process inefficiency or inadequacy

    • Quality Assurance and Quality Control Aspects

    Conducting ISO 11607-2 testing demonstrates a commitment to quality assurance and quality control practices, which are essential for ensuring product safety and reliability.

    Competitive Advantages of Having this Testing Performed

    Performing ISO 11607-2 testing provides several competitive advantages, including:

  • Enhanced brand reputation and customer trust

  • Improved market share due to increased product safety and reliability

  • Reduced costs associated with recalls or product failures

    • ---

    Test Methodologies

    ISO 11607-2 specifies several test methodologies for evaluating the performance of sterile barrier systems, including:

  • Sealing efficiency

  • Sterilization process validation

  • Material compatibility testing

  • Packaging system integrity testing

    • Validation Requirements

    The standard requires manufacturers to validate their forming, sealing, and testing processes using a combination of statistical methods (e.g., FMEA, DOE) and physical tests (e.g., tensile strength, burst pressure).

    Packaging System Integrity Testing

    This test evaluates the ability of sterile barrier systems to maintain packaging integrity throughout the sterilization process.

    Material Compatibility Testing

    This test assesses the compatibility of packaging materials with various sterilization processes.

    Sterilization Process Validation

    This validation involves testing the sterilization process to ensure that it is effective in achieving the required level of sterility.

    ---

    Conclusion

    In conclusion, ISO 11607-2 is a critical standard for ensuring the safety and reliability of sterile barrier systems. By conducting ISO 11607-2 testing, manufacturers can ensure compliance with regulatory requirements, prevent costly recalls or product failures, and enhance their brand reputation and customer trust.

    Eurolabs expertise in ISO 11607-2 testing provides manufacturers with a reliable and efficient means of ensuring the safety and reliability of their sterile barrier systems.

    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