EUROLAB
iso-11607-2-packaging-system-validation-under-thermal-stress
Thermal Resistance and Environmental Testing ASTM D1500 Heat Aging of Insulating MaterialsASTM D1929 Thermal Ignition of PolymersASTM D2240 Hardness Testing After Thermal ExposureASTM D2765 Thermal Stability of PolymersASTM D3039 Thermal Fatigue Testing of CompositesASTM D3045 Thermal Aging of PlasticsASTM D3895 Oxygen Index and Thermal StabilityASTM D3895 Thermal Degradation of PolymersASTM D4065 Dynamic Mechanical Thermal AnalysisASTM D412 Thermal Aging of ElastomersASTM D573 Heat Resistance of RubberASTM D618 Conditioning for Thermal AnalysisASTM D618 Conditioning of Plastics under Thermal ExposureASTM D648 Heat Deflection Temperature TestingASTM D648 Heat Deflection Testing of PlasticsASTM D695 Compressive Strength After Thermal ExposureASTM D746 Brittleness Temperature TestingASTM D785 Thermal Deformation TestingASTM D7945 Thermal Stability of CompositesASTM E595 Thermal Emission TestingASTM F1278 Thermal Cycling of Medical PolymersASTM F1576 Thermal Conductivity TestingASTM F1980 Accelerated Aging of Sterilized Medical DevicesASTM F1980 Accelerated Thermal Aging of Medical DevicesASTM F1981 Thermal Compatibility of Medical AdhesivesASTM F1983 Thermal Compatibility of MaterialsASTM F1984 Thermal Cycling of Sterilized ProductsASTM F2009 Thermomechanical Testing of DevicesASTM F2461 Thermal Performance of Medical Device CoatingsASTM F2477 Thermal Aging of Silicone ElastomersASTM F2516 Thermal Conductivity of Medical Device MaterialsASTM F2621 Thermal Expansion TestingASTM F3001 Thermal Endurance of ImplantsASTM F392 Thermal Resistance of Medical TubingIEC 60068-2-1 Cold Temperature TestingIEC 60068-2-11 Salt Fog with Thermal ExposureIEC 60068-2-14 Rapid Thermal Shock TestingIEC 60068-2-14 Thermal Shock Test MethodIEC 60068-2-14 Thermal Shock TestingIEC 60068-2-2 Dry Heat TestIEC 60068-2-20 Low Temperature and Thermal CyclingIEC 60068-2-30 Damp Heat, Cyclic (12+12 hour)IEC 60068-2-38 Dry Heat, Steady StateIEC 60068-2-4 Rapid Change of TemperatureIEC 60068-2-5 Combined Environmental Testing Including ThermalIEC 60068-2-78 Damp Heat, Steady StateIEC 60529 Environmental Protection Ratings and Thermal ImpactIEC 60529 Protection Against Environmental Thermal ConditionsIEC 60529 Protection Degree and Thermal ImpactIEC 60601-1 Medical Electrical Equipment Safety at Thermal LimitsIEC 60601-1 Thermal Safety RequirementsIEC 60601-1-11 Environmental Conditions for Medical Electrical EquipmentIEC 60601-1-11 Thermal Performance in Home Healthcare DevicesIEC 60601-1-2 Electromagnetic and Thermal ImmunityIEC 60601-1-8 Temperature Alarm SystemsIEC 60601-2-4 Temperature Limits for DefibrillatorsIEC 60749-23 Thermal Shock for Semiconductor DevicesISO 10993-1 Biological Evaluation Considering Thermal EffectsISO 10993-10 Sensitization Tests under Thermal ExposureISO 10993-10 Thermal Sensitization TestingISO 10993-11 Evaluation of Thermal Effects on Medical DevicesISO 10993-12 Sample Preparation with Thermal ConsiderationsISO 10993-18 Chemical Characterization Considering Thermal ExposureISO 10993-4 Hemocompatibility Testing under Thermal StressISO 10993-5 Cytotoxicity Testing after Thermal ExposureISO 11135 Thermal Effects in Ethylene Oxide SterilizationISO 11135 Thermal Process Validation for EO SterilizationISO 11135-1 EO Gas Thermal Process MonitoringISO 11137-2 Thermal Validation of Sterilization CyclesISO 11137-3 Radiation Sterilization and Thermal EffectsISO 11607 Packaging Performance under Thermal StressISO 13485 Quality Management Including Thermal ControlsISO 13485 Thermal Control in Manufacturing ProcessesISO 13485 Thermal Management in Medical Device ManufacturingISO 13485-1 Quality Systems and Thermal ControlsISO 13943 Fire Safety and Thermal Risk in DevicesISO 14644-1 Cleanroom Environmental MonitoringISO 14644-2 Thermal Stability in CleanroomsISO 14644-3 Cleanroom Testing and Thermal ConditionsISO 14644-4 Monitoring Thermal Conditions in CleanroomsISO 14698-1 Biocontamination Control Under Thermal ConditionsISO 14937 Thermal Process ValidationISO 14937 Thermal Validation of Sterilization ProcessesISO 14971 Risk Management for Thermal HazardsISO 14971 Thermal Risk ManagementISO 16750 Environmental Testing for Automotive Electrical EquipmentISO 16750 Environmental Tests Including Thermal CyclingISO 16750-4 Electrical Equipment Environmental Thermal TestingISO 16750-4 Environmental Testing for Electrical EquipmentISO 21789 Environmental Stress Testing for Medical Devices

ISO 11607-2 Packaging System Validation under Thermal Stress Laboratory Testing Service

Eurolabs Expertise and Capabilities

Standard-Related Information

The packaging of pharmaceutical products is a critical aspect of the supply chain, ensuring that products are delivered safely and effectively. To ensure compliance with regulatory requirements and industry standards, manufacturers must validate their packaging systems under various stress conditions. ISO 11607-2 Packaging System Validation under Thermal Stress testing is a laboratory testing service designed to evaluate the performance of packaging systems under thermal stress.

The relevant international standards governing this testing service include:

  • ISO 11607-1:2016: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
  • ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and testing of sterilization barriers and packaging systems
  • ASTM F1980-18: Standard Practice for Validation of Medical Devices - Packaging Systems
  • These standards provide a comprehensive framework for ensuring the safety and efficacy of pharmaceutical products. Manufacturers must comply with these regulations to ensure product quality and regulatory compliance.

    Standard Development Organizations

    The development of international standards is overseen by organizations such as:

  • International Organization for Standardization (ISO): A non-governmental organization responsible for promoting worldwide proprietary, industrial, and commercial standards.
  • American Society for Testing and Materials (ASTM): A non-profit organization that develops and publishes voluntary consensus standards.
  • These organizations work together to develop and update standards to ensure industry relevance and effectiveness.

    Standard Requirements and Needs

    This specific test is necessary because packaging systems must be validated under various stress conditions, including thermal stress. The consequences of not performing this test can include:

  • Product failure: Packaging systems that fail to meet regulatory requirements may lead to product recall or failure.
  • Regulatory non-compliance: Manufacturers who do not comply with regulations may face fines and penalties.
  • The industries that require this testing include:

  • Pharmaceuticals: Manufacturers of pharmaceutical products must ensure that packaging systems meet regulatory requirements.
  • Medical devices: Manufacturers of medical devices, including sterile barrier systems and packaging systems, must be validated under thermal stress conditions.
  • Test Conditions and Methodology

    The test is conducted using the following equipment and instruments:

  • Thermal shock testing chamber: A controlled environment for subjecting samples to extreme temperature fluctuations.
  • Thermocouples: Devices used to measure temperature changes during the testing process.
  • Data acquisition software: Software used to record and analyze data collected during the test.
  • The testing environment requirements include:

  • Temperature range: The thermal shock testing chamber must be capable of maintaining temperatures between -40C and 150C.
  • Humidity control: The testing environment should maintain a relative humidity level between 30 and 70.
  • The sample preparation procedures involve preparing samples according to the relevant standard requirements.

    Test Reporting and Documentation

    The test results are documented and reported in accordance with the following standards:

  • ISO 13485:2016: Medical devices - Quality management systems
  • EN ISO 9001:2015: Quality management systems
  • The report format and structure include:

  • Summary of findings: A concise summary of test results, including any deviations or non-compliances.
  • Test data: Raw data collected during the testing process.
  • Why This Test Should Be Performed

    Performing this test is essential because it ensures regulatory compliance, product safety, and quality assurance. The benefits of performing this test include:

  • Regulatory compliance: Manufacturers who comply with regulations reduce the risk of fines and penalties.
  • Product safety: Validating packaging systems under thermal stress conditions ensures that products are delivered safely and effectively.
  • Quality assurance: Performing this test ensures that manufacturers meet quality standards.
  • Why Eurolab Should Provide This Service

    Eurolab provides this service because it has:

  • Expertise and experience: Eurolabs staff have extensive knowledge and expertise in laboratory testing services, including packaging system validation under thermal stress.
  • State-of-the-art equipment: Eurolabs facilities are equipped with the latest technology, ensuring accurate and reliable test results.
  • Accreditation and certification: Eurolab is accredited by relevant national and international organizations.
  • Eurolab provides a comprehensive laboratory testing service for packaging system validation under thermal stress. The benefits of choosing Eurolab include:

  • Quality management systems: Eurolabs quality management system ensures that all testing services meet industry standards.
  • Customer service and support capabilities: Eurolabs staff provide exceptional customer service and support throughout the testing process.
  • Turnaround time and efficiency advantages: Eurolab offers fast turnaround times, ensuring that manufacturers receive test results promptly.
  • In conclusion, ISO 11607-2 Packaging System Validation under Thermal Stress testing is a critical laboratory testing service for manufacturers who want to ensure regulatory compliance, product safety, and quality assurance. By choosing Eurolabs expert services, manufacturers can rest assured that their packaging systems meet industry standards.

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