EUROLAB
iso-13408-7-aseptic-connections
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 868-5 Heat Sealable PouchesEN 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 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

ISO 13408-7 Aseptic Connections Laboratory Testing Service Provided by Eurolab

Standard-Related Information

ISO 13408-7 is a standard that specifies the requirements for laboratory testing of aseptic connections in medical devices. This standard is part of the ISO 13408 series, which covers various aspects of medical device testing.

The standard is developed and published by the International Organization for Standardization (ISO), a non-governmental organization that brings together experts from around the world to develop voluntary standards.

Why is ISO 13408-7 Important?

The legal and regulatory framework surrounding this testing service is governed by international and national standards. For example, in the European Union, medical devices must comply with the Medical Device Regulation (MDR), which requires that devices meet certain safety and performance requirements. ISO 13408-7 provides a framework for laboratory testing to ensure that aseptic connections are safe and effective.

International and National Standards

ISO 13408-7 is just one of many standards related to medical device testing. Some other relevant standards include:

  • ISO 11135:2009 (Hydrogen peroxide - sterilization residue)

  • ISO 11607-1:2016 (Packaging for terminally sterilized medical devices - Part 1: Requirements)

  • EN 285:2018 (Sterilizers using a hot air process)

    • Standard Development Organizations

    Standards are developed by various organizations, including:

  • International Organization for Standardization (ISO)

  • European Committee for Standardization (CEN)

  • American Society for Testing and Materials (ASTM)

  • Turkish Standards Institution (TSE)

    • These organizations bring together experts from around the world to develop voluntary standards that reflect best practices.

    How Do Standards Evolve?

    Standards are reviewed and updated regularly to reflect advances in technology, changes in regulations, or new research findings. This ensures that standards remain relevant and effective.

    Specific Standard Numbers and Scope

    Some specific standard numbers related to ISO 13408-7 include:

  • ISO 13408-7:2015 (Aseptic connections - Part 7: Laboratory testing)

  • EN 12442-1:2002A1:2011 (Medical devices - Aseptic processing - Part 1: Requirements for equipment, processes and materials)

    • Compliance Requirements

    Compliance with ISO 13408-7 is mandatory for medical device manufacturers that want to ensure the safety and effectiveness of their products.

    Standard Requirements and Needs

    Why is this Specific Test Needed?

    The testing of aseptic connections is crucial to ensure the safety and efficacy of medical devices. This test helps to prevent contamination, which can lead to serious health problems or even death.

    Business and Technical Reasons for Conducting ISO 13408-7 Testing

    Conducting this test provides several benefits, including:

  • Ensuring product safety and reliability

  • Compliance with regulatory requirements

  • Improving quality assurance and control

  • Enhancing customer confidence and trust

    • Consequences of Not Performing this Test

    Failing to conduct this test can lead to serious consequences, including:

  • Product recalls

  • Regulatory fines and penalties

  • Loss of business reputation and revenue

  • Patient harm or death

    • Industries and Sectors that Require this Testing

    This testing is required for various industries, including:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Healthcare institutions

    • Risk Factors and Safety Implications

    The risk factors associated with contaminated medical devices include:

  • Infection and illness

  • Patient harm or death

  • Regulatory penalties and fines

    • Quality Assurance and Control Aspects

    Conducting this test provides several quality assurance and control benefits, including:

  • Ensuring product safety and reliability

  • Improving manufacturing processes and procedures

  • Enhancing customer confidence and trust

    • How this Test Contributes to Product Safety and Reliability

    This test contributes to product safety and reliability by ensuring that aseptic connections are safe and effective.

    Competitive Advantages of Having this Testing Performed

    Conducting this test provides several competitive advantages, including:

  • Compliance with regulatory requirements

  • Improving quality assurance and control

  • Enhancing customer confidence and trust

  • Increasing market share and revenue

    • Cost-Benefit Analysis of Performing this Test

    The cost-benefit analysis of performing this test is clear: while it may require significant investment upfront, the long-term benefits far outweigh the costs.

    Test Conditions and Methodology

    How is the Test Conducted?

    The testing process involves several steps:

    1. Sample preparation

    2. Testing equipment calibration

    3. Testing parameters setup

    4. Testing execution

    5. Data analysis and reporting

    Testing Equipment and Instruments Used

    Various testing equipment and instruments are used, including:

  • Sterilizers

  • Autoclaves

  • Microbiological analyzers

  • pH meters

    • Testing Environment Requirements

    The testing environment requires:

  • Temperature control (20-25C)

  • Humidity control (50-60)

  • Air quality monitoring

  • Sterility assurance

    • Data Analysis and Reporting

    Data analysis involves:

  • Statistical analysis of results

  • Identification of trends and patterns

  • Generation of reports and certificates

    • Test Results and Certificates

    Test results are documented in a report, which includes:

  • Summary of testing results

  • Details of testing parameters

  • Conclusions and recommendations

    • Conclusion

    In conclusion, ISO 13408-7 is an essential standard for laboratory testing of aseptic connections. Conducting this test provides several benefits, including ensuring product safety and reliability, compliance with regulatory requirements, improving quality assurance and control, and enhancing customer confidence and trust.

    By understanding the importance of this standard and conducting the required tests, manufacturers can ensure that their products meet the highest standards of safety and effectiveness.

    Eurolab: Your Partner in Medical Device Testing

    At Eurolab, we are committed to providing high-quality testing services for medical devices. Our team of experts has extensive knowledge and experience in laboratory testing, including aseptic connections.

    Contact us today to learn more about our testing services and how we can help you ensure the safety and effectiveness of your products.

    References

  • ISO 13408-7:2015 (Aseptic connections - Part 7: Laboratory testing)

  • EN 12442-1:2002A1:2011 (Medical devices - Aseptic processing - Part 1: Requirements for equipment, processes and materials)

  • MDR (Medical Device Regulation)

    • Need help or have a question?
    Contact us for prompt assistance and solutions.

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