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en-868-5-heat-sealable-pouches
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 868-6 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. 5.1.6 Container Closure Integrity for Sterile ProductsPh. 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 EN 868-5 Heat Sealable Pouches Laboratory Testing Service

Standard-Related Information

The European Standard (EN) 868-5 is a comprehensive document that outlines the requirements for heat sealable pouches used in medical devices. The standard is published by the European Committee for Standardization (CEN) and is widely adopted across Europe and other regions.

EN 868-5 is part of the EN 868 series, which covers various aspects of packaging materials for medical devices. This particular standard focuses on heat sealable pouches, specifying their performance requirements, testing methods, and acceptance criteria.

International and National Standards

EN 868-5 is based on ISO 11607-1:2019 (Packaging for terminally sterilized medical devices), which provides a framework for packaging systems. The standard also references other relevant international standards, such as ASTM F2090-08 (Standard Test Method for Single-Folder Pouches for Packaging of Pre-Sterilized Medical Instruments) and TSE 2004 (Turkish Standard for Packaging Materials).

In addition to EN 868-5, several national standards are based on or equivalent to this European standard. These include:

  • ISO 11607-1:2019 (Packaging for terminally sterilized medical devices)

  • ASTM F2090-08 (Standard Test Method for Single-Folder Pouches for Packaging of Pre-Sterilized Medical Instruments)

  • TSE 2004 (Turkish Standard for Packaging Materials)

    • Standard Development Organizations

    The standard development process involves collaboration between various stakeholders, including manufacturers, users, and regulatory bodies. Key organizations involved in the development and maintenance of EN 868-5 include:

  • CEN (European Committee for Standardization)

  • ISO (International Organization for Standardization)

  • ASTM (American Society for Testing and Materials)

    • Standard Evolution and Update

    Standards are regularly reviewed and updated to reflect changing industry needs, advancements in technology, and new scientific knowledge. The standard development process involves a thorough review of existing standards, identification of areas for improvement, and development of new requirements.

    Standard Requirements and Needs

    EN 868-5 Heat Sealable Pouches testing is essential for ensuring the integrity and performance of medical devices packaged in heat sealable pouches. The standard specifies various requirements, including:

  • Material properties (e.g., thermal resistance, permeability)

  • Performance under different conditions (e.g., temperature, humidity)

  • Testing methods (e.g., peel strength, burst pressure)

    • The consequences of not performing this test include:

  • Non-compliance with regulatory requirements

  • Risk to patient safety and device efficacy

  • Economic losses due to product recalls or rework

    • Industries and Sectors

    EN 868-5 Heat Sealable Pouches testing is relevant to various industries, including:

  • Medical devices (e.g., surgical instruments, implantable devices)

  • Pharmaceutical packaging

  • Sterilization services

  • Packaging manufacturers

    • Risk Factors and Safety Implications

    The failure of heat sealable pouches can lead to serious consequences, including:

  • Device contamination or damage

  • Patient injury or death

  • Economic losses due to product recalls or rework

    • Quality Assurance and Quality Control Aspects

    EN 868-5 Heat Sealable Pouches testing contributes to quality assurance and control by ensuring that packaging materials meet specific requirements. This includes:

  • Material selection and sourcing

  • Packaging design and development

  • Production process validation and monitoring

  • Testing and inspection

    • Competitive Advantages and Cost-Benefit Analysis

    Performing EN 868-5 Heat Sealable Pouches testing offers several competitive advantages, including:

  • Compliance with regulatory requirements

  • Improved product safety and reliability

  • Enhanced customer confidence and trust

  • Increased market access and trade facilitation

    • The cost-benefit analysis of performing this test includes:

  • Reduced costs associated with product recalls or rework

  • Improved production efficiency and reduced waste

  • Enhanced reputation and brand image

  • Compliance with regulatory requirements

    • Test Conditions and Methodology

    EN 868-5 Heat Sealable Pouches testing involves several steps, including:

    1. Sample preparation (e.g., cutting, folding)

    2. Testing equipment setup (e.g., thermocouples, pressure gauges)

    3. Testing procedures (e.g., peel strength, burst pressure)

    4. Data collection and analysis

    Test Reporting and Documentation

    The test report for EN 868-5 Heat Sealable Pouches testing should include:

  • Test results and data

  • Sample information (e.g., material, dimensions)

  • Testing conditions (e.g., temperature, humidity)

  • Calibration and validation procedures

  • Quality control measures during testing

    • Why this Test Should be Performed

    EN 868-5 Heat Sealable Pouches testing is essential for ensuring the safety and efficacy of medical devices packaged in heat sealable pouches. The benefits of performing this test include:

  • Compliance with regulatory requirements

  • Improved product safety and reliability

  • Enhanced customer confidence and trust

  • Increased market access and trade facilitation

    • Conclusion

    EN 868-5 Heat Sealable Pouches testing is a critical aspect of ensuring the integrity and performance of medical devices packaged in heat sealable pouches. This comprehensive guide provides an overview of the standard, its requirements, and the benefits of performing this test.

    By understanding the importance of EN 868-5 Heat Sealable Pouches testing, manufacturers can ensure compliance with regulatory requirements, improve product safety and reliability, and enhance customer confidence and trust.

    References

  • CEN (2019). EN 868-5: Packaging for terminally sterilized medical devices Part 5: Heat sealable pouches.

  • ISO (2019). ISO 11607-1:2019 (Packaging for terminally sterilized medical devices).

  • ASTM (2008). ASTM F2090-08 (Standard Test Method for Single-Folder Pouches for Packaging of Pre-Sterilized Medical Instruments).

    • Appendices

    A. Glossary of Terms

    B. Testing Methods and Equipment

    C. Sample Preparation and Handling

    D. Calibration and Validation Procedures

    E. Quality Control Measures During Testing

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