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en-868-3-paper-for-use-in-sterilization
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 868-4 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 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

EN 868-3 Paper for Use in Sterilization: Laboratory Testing Services by Eurolab

EN 868-3 is a European standard that specifies the requirements for paper used in sterilization processes, including medical devices and equipment. The standard is part of the EN 868 series, which covers various aspects of packaging materials for medical devices.

The relevant standards governing EN 868-3 Paper for Use in Sterilization testing are:

  • ISO 11137:2006A1:2012 (Sterilization of health care products - Radiation - Particular requirements for the validation and control of sterilization processes)

  • ASTM F2100-07 (Standard Specification for Performance of Materials Used in Protective Clothing Against Chemicals)

  • EN 868-3:1999 (Medical devices - Packaging materials - Part 3: Requirements for paper used in sterilization processes)

    • The legal and regulatory framework surrounding this testing service includes:

  • EU Directive 93/42/EEC (Medical Devices Directive)

  • EU Regulation 2017/745 (Medical Device Regulation)

  • ISO 13485:2016 (Quality Management Systems - Medical Devices - Requirements for Regulatory Purposes)

    • Standard development organizations that govern EN 868-3 include:

  • CEN (European Committee for Standardization)

  • ISO (International Organization for Standardization)

  • ASTM International

    • Standards evolve and get updated through a rigorous process involving input from stakeholders, industry experts, and regulatory bodies. The most recent update to EN 868-3 was in 1999.

    Standard compliance requirements vary depending on the industry, but some common requirements include:

  • Material selection and sourcing

  • Manufacturing processes and controls

  • Testing and validation

  • Quality management systems

    • EN 868-3 Paper for Use in Sterilization testing is necessary to ensure that paper used in sterilization processes meets the required standards. The business and technical reasons for conducting this test include:

  • Ensuring product safety and reliability

  • Meeting regulatory requirements

  • Maintaining quality control and assurance

  • Reducing the risk of contamination and errors

  • Improving customer confidence and trust

    • The industries and sectors that require EN 868-3 Paper for Use in Sterilization testing are primarily medical device manufacturers, pharmaceutical companies, and laboratories.

    Risk factors and safety implications associated with non-compliance include:

  • Contamination and sterilization failures

  • Product recalls and liability

  • Regulatory penalties and fines

  • Loss of customer trust and business

    • Quality assurance and quality control aspects of EN 868-3 testing involve:

  • Material selection and sourcing

  • Manufacturing process controls

  • Testing and validation

  • Quality management system implementation

    • This test contributes to product safety and reliability by ensuring that paper used in sterilization processes meets the required standards.

    EN 868-3 Paper for Use in Sterilization testing involves a series of steps, including:

    1. Sample preparation: The paper sample is prepared according to the standard requirements.

    2. Testing equipment: The testing equipment used includes radiation sources, temperature control systems, and measurement instruments.

    3. Testing environment: The testing environment requires a controlled atmosphere with specific temperature and humidity conditions.

    4. Testing parameters: The testing parameters include radiation dose, exposure time, and temperature.

    5. Measurement and analysis: The measurement and analysis methods involve detecting radiation-induced changes in the paper sample.

    The testing equipment used includes:

  • Radiation sources (e.g., cobalt-60)

  • Temperature control systems

  • Humidity control systems

  • Measurement instruments (e.g., dosimeters)

    • The testing environment requires specific temperature and humidity conditions, which are maintained using climate-controlled chambers or other specialized equipment.

    EN 868-3 Paper for Use in Sterilization test results are documented and reported according to the standard requirements. The report format includes:

  • Test summary

  • Test conditions

  • Results and conclusions

  • Recommendations

    • The interpretation of test results involves evaluating the paper samples performance against the required standards.

    Certification and accreditation aspects involve:

  • Accreditation by recognized third-party organizations (e.g., ISO 17025)

  • Certification by regulatory bodies or industry associations

  • Traceability and documentation requirements

    • Reporting standards and formats include:

  • EU directives and regulations

  • International standards (e.g., ISO 11137)

  • Industry-specific guidelines and recommendations

    • Results are validated and verified through a series of checks, including:

  • Reviewing test data and results

  • Verifying equipment calibration and maintenance records

  • Conducting additional testing as required

    • Electronic reporting systems used include:

  • Laboratory information management systems (LIMS)

  • Testing software and databases

  • Electronic document management systems

    • Confidentiality and data protection measures involve:

  • Secure storage of sensitive data

  • Access controls and permissions

  • Data encryption and anonymization

    • Conclusion

    EN 868-3 Paper for Use in Sterilization testing is essential to ensure that paper used in sterilization processes meets the required standards. The standard requirements and needs, test conditions and methodology, and test reporting and documentation aspects are critical components of this testing service.

    Eurolabs laboratory testing services provide a comprehensive solution for meeting EN 868-3 Paper for Use in Sterilization testing requirements. Our experienced team and state-of-the-art equipment ensure accurate and reliable results.

    Recommendations

    To ensure compliance with EN 868-3, manufacturers and suppliers should:

  • Select materials that meet the required standards

  • Implement quality management systems to control manufacturing processes

  • Conduct regular testing and validation to ensure product safety and reliability

    • Regulatory bodies and industry associations should:

  • Develop and update standards and guidelines as needed

  • Provide education and training on standard requirements

  • Encourage compliance and best practices among manufacturers and suppliers

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

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