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iso-11607-mechanical-performance-of-packaging
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Comprehensive Guide to ISO 11607 Mechanical Performance of Packaging Laboratory Testing Service by Eurolab

ISO 11607 is an international standard that specifies the requirements for packaging systems for medical devices intended for single-use, including syringes, pre-filled syringes, and prefilled cartridges. The standard aims to ensure that packaging systems meet the necessary performance criteria to maintain sterility and prevent contamination during transportation and storage.

The relevant standards governing ISO 11607 Mechanical Performance of Packaging testing are:

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

  • ISO 11607-2:2016: Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and testing sterilization

  • ASTM F1980-14: Standard Practice for Packaging and Transportation of Terminally Sterilized Medical Devices

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

    • These standards are developed by the International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the European Committee for Standardization (CEN). The development of these standards is overseen by various standard development organizations, including the ISO/TC 198 committee.

    Standard development involves a rigorous process that includes:

    1. Proposal: A proposal is submitted to the relevant standard development organization.

    2. Committee review: The proposal is reviewed and discussed by experts in the field.

    3. Drafting: A draft of the standard is prepared based on the discussions and agreements reached during the committee review.

    4. Balloting: The draft is sent for voting to member countries, and feedback is collected.

    5. Finalization: The final version of the standard is prepared after incorporating the comments and suggestions received.

    Standards evolve and get updated regularly to reflect changes in technology, regulations, or industry practices. Eurolab stays up-to-date with the latest standards developments and ensures that its testing services meet the current requirements.

    ISO 11607 Mechanical Performance of Packaging testing is required for medical devices intended for single-use to ensure that packaging systems maintain sterility during transportation, storage, and handling. This test verifies that the packaging system meets the necessary performance criteria, including:

    1. Resistance to moisture vapor transmission: The packaging system must prevent moisture from entering or escaping.

    2. Sterilization: The packaging system must be able to withstand sterilization processes without compromising the sterility of the device.

    3. Transportation and handling: The packaging system must be able to withstand transportation, storage, and handling without compromising the sterility of the device.

    The consequences of not performing this test include:

    1. Compromised sterility: Devices may become contaminated during transportation or storage, leading to patient harm or recalls.

    2. Recalls and withdrawals: Failure to meet packaging standards can result in costly recalls or product withdrawals.

    3. Regulatory non-compliance: Medical devices that do not comply with ISO 11607 requirements may not be approved for sale.

    This testing is required by various industries, including:

    1. Medical device industry: All medical devices intended for single-use must meet the packaging standards specified in ISO 11607.

    2. Pharmaceutical industry: Packaging systems for pharmaceuticals and biological products must comply with relevant regulations, including ISO 11607.

    The risk factors associated with not performing this test include:

    1. Patient harm: Contaminated devices can cause patient harm or even death.

    2. Financial losses: Recalls and withdrawals can result in significant financial losses due to costs associated with recall, replacement, and reputational damage.

    3. Regulatory penalties: Failure to comply with regulations can lead to fines, penalties, or imprisonment.

    Quality assurance and quality control aspects are crucial for ensuring the accuracy and reliability of ISO 11607 Mechanical Performance of Packaging testing results. This includes:

    1. Calibration and validation: Testing equipment must be calibrated and validated regularly.

    2. Sample preparation: Samples must be prepared according to standard procedures to ensure consistency and accuracy.

    3. Testing parameters: Testing parameters must be optimized for each specific test.

    This testing contributes significantly to product safety and reliability by ensuring that packaging systems meet the necessary performance criteria. By performing this test, medical device manufacturers can:

    1. Ensure compliance with regulations: Medical devices will comply with relevant regulations and standards.

    2. Enhance patient safety: Devices will be free from contamination, reducing the risk of patient harm or recalls.

    3. Gain competitive advantage: Companies that perform this testing can demonstrate their commitment to product safety and quality.

    ISO 11607 Mechanical Performance of Packaging testing involves a series of specific steps:

    1. Sample preparation: Samples are prepared according to standard procedures.

    2. Testing parameters: Testing parameters, including temperature, humidity, and pressure, must be optimized for each specific test.

    3. Moisture vapor transmission rate (MVTR) measurement: The MVTR is measured using a gravimetric method or an electrodynamic balance.

    4. Sterilization simulation: Sterilization simulation involves exposing the packaging system to a sterilizing agent, such as ethylene oxide or gamma radiation.

    5. Transportation and handling simulations: Transportation and handling simulations involve subjecting the packaging system to various transportation modes (e.g., shipping) and handling conditions (e.g., drops).

    Eurolab follows standard procedures for testing equipment calibration, validation, and maintenance to ensure accuracy and reliability of results.

    Test Conditions

    ISO 11607 Mechanical Performance of Packaging testing is typically performed in controlled environments with specific temperature and humidity levels. For example:

    1. Temperature: The test is conducted at a temperature between -30C and 60C.

    2. Humidity: The relative humidity must be between 20 and 80.

    3. Pressure: The pressure must be within the range of 0.01 to 100 Pa.

    Methodology

    Eurolab follows standard procedures for testing, including:

    1. Sample preparation: Samples are prepared according to standard procedures.

    2. Testing equipment calibration: Testing equipment is calibrated regularly to ensure accuracy and reliability of results.

    3. Data analysis: Data is analyzed using statistical methods to determine the MVTR and other relevant parameters.

    ISO 11607 Mechanical Performance of Packaging testing is an essential step in ensuring that medical devices intended for single-use meet packaging standards specified in ISO 11607. Eurolab stays up-to-date with standard developments and ensures that its testing services meet current requirements.

    In the next section, we will discuss:

    1. ISO 11607-2: Requirements for sterilization simulation and transportation/handling simulations.

    2. ASTM F1980: Standard practice for packaging and transportation of terminally sterilized medical devices.

    Please refer to the following sections for additional information on ISO 11607 Mechanical Performance of Packaging testing:

    2. Test Conditions and Methodology: Sample preparation, testing parameters, MVTR measurement, sterilization simulation, transportation/handling simulations.

    Please contact Eurolab for further information or to schedule a test.

    Need help or have a question?
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