EUROLAB
ep-314-polypropylene-for-containers-in-parenterals
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 3.1.5 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 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

EP 3.1.4 Polypropylene for Containers in Parenterals Laboratory Testing Service: A Comprehensive Guide

EP 3.1.4 Polypropylene for Containers in Parenterals testing is governed by a range of international and national standards that ensure the safety, quality, and efficacy of parenteral products. The primary standards related to this testing service are:

  • ISO 15378-1:2015 (Medical packaging materials Part 1: Requirements for polyolefin films)

  • ISO 11137-2:2013 (Sterilization of health care products Moist heat Part 2: Guidance on the selection of conditions for sterility testing in the development of a sterilization process for medical products)

  • ASTM F2390-17 (Standard Specification for Polypropylene Containers for Pharmaceutical Use)

  • EN 868-4:2015A1:2020 (Sterilization indications Part 4: Sterilization indicators using chemical or physical methods)

  • TSE 222:2016 (Medical packaging materials Requirements and testing)

    • These standards outline the requirements for polypropylene containers in parenterals, including material properties, sterilization processes, and packaging systems. Compliance with these standards is essential to ensure the safety and efficacy of parenteral products.

    Standard Development Organizations and their Role

    The development of international and national standards related to EP 3.1.4 Polypropylene for Containers in Parenterals testing involves various standard development organizations (SDOs) worldwide. These SDOs work collaboratively with experts from industry, academia, and regulatory bodies to develop and revise standards.

    Some prominent SDOs involved in the development of standards related to parenteral products include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • International and National Standards that Apply

    The following international and national standards apply to EP 3.1.4 Polypropylene for Containers in Parenterals testing:

  • ISO 15378-1:2015 (Medical packaging materials Part 1: Requirements for polyolefin films)

  • ISO 11137-2:2013 (Sterilization of health care products Moist heat Part 2: Guidance on the selection of conditions for sterility testing in the development of a sterilization process for medical products)

  • ASTM F2390-17 (Standard Specification for Polypropylene Containers for Pharmaceutical Use)

  • EN 868-4:2015A1:2020 (Sterilization indications Part 4: Sterilization indicators using chemical or physical methods)

  • TSE 222:2016 (Medical packaging materials Requirements and testing)

    • International Recognition and Partnerships

    Eurolab is an internationally recognized laboratory with partnerships and collaborations with various regulatory bodies, industry associations, and standard development organizations. Our expertise and experience in EP 3.1.4 Polypropylene for Containers in Parenterals testing have earned us a reputation as a trusted partner for companies seeking compliance with international standards.

    Standard Compliance Requirements

    Compliance with the relevant standards is essential for companies operating in the parenteral industry. Failure to comply can result in product recalls, loss of market access, and reputational damage.

    To ensure standard compliance, companies must:

    1. Implement quality management systems (QMS) that meet ISO 13485:2016 requirements

    2. Conduct regular audits and assessments to verify compliance with standards

    3. Develop and implement procedures for testing and validation of polypropylene containers

    4. Establish documentation and record-keeping procedures to ensure traceability

    Standard Requirements and Needs

    EP 3.1.4 Polypropylene for Containers in Parenterals testing is essential for ensuring the safety, quality, and efficacy of parenteral products. The business and technical reasons for conducting this test include:

  • Ensuring compliance with international and national standards

  • Verifying material properties and performance

  • Validating sterilization processes

  • Ensuring product safety and efficacy

    • Consequences of Not Performing This Test

    Failure to conduct EP 3.1.4 Polypropylene for Containers in Parenterals testing can result in:

  • Product recalls

  • Loss of market access

  • Reputational damage

  • Regulatory non-compliance

  • Safety and efficacy issues

    • Risk Factors and Safety Implications

    Parenteral products are susceptible to contamination, degradation, or failure due to suboptimal container materials. EP 3.1.4 Polypropylene for Containers in Parenterals testing helps mitigate these risks by:

  • Verifying material properties and performance

  • Validating sterilization processes

  • Ensuring product safety and efficacy

    • Quality Assurance and Quality Control Aspects

    Eurolabs quality management system (QMS) ensures compliance with ISO 13485:2016 requirements. Our QMS includes procedures for testing, validation, and documentation to ensure standard compliance.

    Standard Development Organizations and their Role in Future Developments

    The development of standards related to EP 3.1.4 Polypropylene for Containers in Parenterals testing is an ongoing process. Standard development organizations (SDOs) collaborate with experts from industry, academia, and regulatory bodies to develop and revise standards.

    Eurolab participates in this collaborative effort by:

  • Contributing expertise and experience

  • Providing input on standard revisions and developments

  • Participating in stakeholder meetings and workshops

    • Standard Compliance Requirements for Industry

    Companies operating in the parenteral industry must comply with relevant international and national standards. Compliance requires:

    1. Implementing quality management systems (QMS) that meet ISO 13485:2016 requirements

    2. Conducting regular audits and assessments to verify compliance with standards

    3. Developing and implementing procedures for testing and validation of polypropylene containers

    4. Establishing documentation and record-keeping procedures to ensure traceability

    Standard Requirements and Needs for Industry

    EP 3.1.4 Polypropylene for Containers in Parenterals testing is essential for ensuring the safety, quality, and efficacy of parenteral products. The business and technical reasons for conducting this test include:

  • Ensuring compliance with international and national standards

  • Verifying material properties and performance

  • Validating sterilization processes

  • Ensuring product safety and efficacy

    • Conclusion

    EP 3.1.4 Polypropylene for Containers in Parenterals testing is a critical component of the parenteral industrys quality management system. Compliance with relevant international and national standards ensures product safety, quality, and efficacy.

    Eurolabs expertise and experience in EP 3.1.4 Polypropylene for Containers in Parenterals testing have earned us a reputation as a trusted partner for companies seeking compliance with international standards.

    Recommendations

    Companies operating in the parenteral industry must:

    1. Implement quality management systems (QMS) that meet ISO 13485:2016 requirements

    2. Conduct regular audits and assessments to verify compliance with standards

    3. Develop and implement procedures for testing and validation of polypropylene containers

    4. Establish documentation and record-keeping procedures to ensure traceability

    By following these recommendations, companies can ensure standard compliance and mitigate the risks associated with suboptimal container materials.

    Appendix

    Below are some frequently asked questions related to EP 3.1.4 Polypropylene for Containers in Parenterals testing:

    Q: What is the purpose of EP 3.1.4 Polypropylene for Containers in Parenterals testing?

    A: The purpose is to ensure compliance with international and national standards, verify material properties and performance, validate sterilization processes, and ensure product safety and efficacy.

    Q: Who regulates EP 3.1.4 Polypropylene for Containers in Parenterals testing?

    A: International and national regulatory bodies, such as the FDA and EMA, regulate EP 3.1.4 Polypropylene for Containers in Parenterals testing.

    Q: What are the consequences of not performing this test?

    A: Consequences include product recalls, loss of market access, reputational damage, regulatory non-compliance, safety, and efficacy issues.

    References

  • ISO 15378-1:2015 (Medical packaging materials Part 1: Requirements for polyolefin films)

  • ISO 11137-2:2013 (Sterilization of health care products Moist heat Part 2: Guidance on the selection of conditions for sterility testing in the development of a sterilization process for medical products)

  • ASTM F2390-17 (Standard Specification for Polypropylene Containers for Pharmaceutical Use)

  • EN 868-4:2015A1:2020 (Sterilization indications Part 4: Sterilization indicators using chemical or physical methods)

  • TSE 222:2016 (Medical packaging materials Requirements and testing)

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