EUROLAB
iso-14937-sterilization-and-extractables-safety-assurance
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 11607-2 Manufacturing Validation for Sterile Barrier SystemsISO 11979-5 Extractables in Intraocular Lens MaterialsISO 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

ISO 14937 Sterilization and Extractables Safety Assurance Laboratory Testing Service: A Comprehensive Guide

As a leading laboratory testing service provider, Eurolab is committed to delivering high-quality results that meet the stringent requirements of ISO 14937 Sterilization and Extractables Safety Assurance. This comprehensive guide aims to provide a detailed understanding of the standard, its requirements, and the benefits of conducting this specific test.

Standard-Related Information

ISO 14937 is an international standard that outlines the requirements for sterilization and extractables safety assurance testing. The standard is developed by ISO (International Organization for Standardization) and is widely recognized as a benchmark for laboratory testing services. EUROLAB, as a certified laboratory, adheres to this standard to ensure that our testing services meet the highest standards of quality and reliability.

Legal and Regulatory Framework

The legal and regulatory framework surrounding sterilization and extractables safety assurance testing is complex and ever-evolving. In many countries, laboratories are required by law to adhere to specific regulations and guidelines when conducting testing services. EUROLABs expertise in this field ensures that we remain up-to-date with the latest developments and changes in legislation.

International and National Standards

Several international and national standards apply to ISO 14937 Sterilization and Extractables Safety Assurance testing, including:

  • ISO 14937:2010(E)

  • ASTM F1478-12

  • EN ISO 11135:2009

  • TSE ISO 11135:2014

    • These standards outline the requirements for laboratory testing services, including sample preparation, testing conditions, and reporting.

    Standard Development Organizations

    Standard development organizations play a crucial role in shaping the global regulatory landscape. EUROLAB is proud to be a member of various standard development organizations, ensuring that our testing services remain aligned with the latest developments in the field.

    How Standards Evolve and Get Updated

    Standards are constantly evolving as new technologies emerge, and scientific understanding improves. Laboratories like EUROLAB must stay up-to-date with the latest changes to ensure that our testing services remain compliant with the relevant standards.

    Standard Numbers and Scope

    The following standard numbers and their scope are essential for ISO 14937 Sterilization and Extractables Safety Assurance testing:

  • ISO 14937:2010(E) - Requirements for sterilization and extractables safety assurance

  • ASTM F1478-12 - Standard practice for preparation of samples for analysis in accordance with the ISO 11135 method

  • EN ISO 11135:2009 - Sterilization requirements for medical devices

  • TSE ISO 11135:2014 - Sterilization requirements for medical devices

    • Industry-Specific Compliance Requirements

    Compliance with industry-specific regulations and guidelines is essential for laboratories like EUROLAB. Our expertise ensures that we meet the unique needs of various industries, including:

  • Medical devices

  • Pharmaceutical products

  • Food packaging materials

  • Cosmetic products

    • Standard Requirements and Needs

    ISO 14937 Sterilization and Extractables Safety Assurance testing is a critical component of quality assurance and regulatory compliance. This test is essential for ensuring that medical devices, pharmaceutical products, food packaging materials, and cosmetic products are safe for human use.

    Why this Test is Needed and Required

    The consequences of not performing ISO 14937 Sterilization and Extractables Safety Assurance testing can be severe, including:

  • Product recalls

  • Damage to reputation

  • Financial losses

  • Regulatory non-compliance

    • This test is required by regulatory bodies worldwide, including the FDA, EU regulations, and national laws.

    Business and Technical Reasons for Conducting ISO 14937 Sterilization and Extractables Safety Assurance Testing

    Conducting this test provides numerous business and technical benefits, including:

  • Reduced risk of product failure

  • Improved quality assurance

  • Enhanced regulatory compliance

  • Competitive advantages in the market

    • Risk Factors and Safety Implications

    Failing to conduct this test can result in significant safety implications, including:

  • Contamination risks

  • Product toxicity

  • Patient harm

  • Regulatory non-compliance

    • Quality Assurance and Quality Control Aspects

    EUROLABs quality assurance and quality control measures ensure that our testing services meet the highest standards of quality and reliability.

    How this Test Contributes to Product Safety and Reliability

    This test is a critical component of product safety and reliability, ensuring that medical devices, pharmaceutical products, food packaging materials, and cosmetic products are safe for human use.

    Competitive Advantages of Having this Testing Performed

    Conducting ISO 14937 Sterilization and Extractables Safety Assurance testing provides numerous competitive advantages, including:

  • Improved brand reputation

  • Enhanced customer trust

  • Increased market share

  • Regulatory compliance benefits

    • Cost-Benefit Analysis of Performing this Test

    While the cost of conducting this test may seem high, the long-term benefits far outweigh the costs. By investing in ISO 14937 Sterilization and Extractables Safety Assurance testing, companies can reduce their risk of product failure, improve regulatory compliance, and enhance their brand reputation.

    Standard Requirements for Laboratory Testing Services

    The standard requirements for laboratory testing services are outlined in ISO 14937, including:

  • Sample preparation

  • Testing conditions

  • Reporting

    • EUROLABs expertise ensures that our testing services meet the highest standards of quality and reliability.

    How to Select a Reliable Laboratory for Sterilization and Extractables Safety Assurance Testing

    When selecting a laboratory for sterilization and extractables safety assurance testing, consider the following factors:

  • Certification to relevant standards (e.g., ISO 14937)

  • Expertise in specific industries (e.g., medical devices, pharmaceutical products)

  • Quality control measures

  • Reporting requirements

    • Conclusion

    ISO 14937 Sterilization and Extractables Safety Assurance laboratory testing service is a critical component of quality assurance and regulatory compliance. By understanding the standard, its requirements, and the benefits of conducting this test, companies can reduce their risk of product failure, improve regulatory compliance, and enhance their brand reputation.

    As a leading laboratory testing service provider, EUROLAB is committed to delivering high-quality results that meet the stringent requirements of ISO 14937 Sterilization and Extractables Safety Assurance.

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