EUROLAB
iso-11607-2-packaging-integrity-testing
Packaging Mechanical Performance ASTM D1974 Performance Testing of Flexible PackagingASTM D2579 Drop Testing of Corrugated BoxesASTM D2579 Drop Testing of PackagingASTM D2656 Seal Strength Testing of Flexible PackagingASTM D3951 Performance Evaluation of Packaging SystemsASTM D3987 Water Resistance of Paperboard PackagingASTM D4168 Packaging Performance under Simulated HandlingASTM D4168-12 Handling and Transit Simulation TestingASTM D4169 Performance Testing of Shipping ContainersASTM D4577 Seal Strength of Flexible PackagesASTM D4727 Performance Testing of Transit PackagingASTM D4727-18 Performance Testing of Corrugated BoxesASTM D5374 Vibration Resistance of PackagingASTM D642 Compression Resistance of Corrugated BoxesASTM D6575 Compression Testing of Corrugated BoardASTM D7438 Flexibility Testing of Packaging MaterialsASTM D781 Compression Strength of PaperboardASTM D829 Seal Strength Testing of Flexible PackagingASTM D999 Dynamic Load Testing of PackagingASTM D999-15 Dynamic Load Testing of PackagesASTM D999-21 Dynamic Load Testing for Shipping PackagesASTM F1306 Impact Resistance Testing of PackagingASTM F1306-16 Impact Resistance TestingASTM F2256 Tear Resistance of Plastic FilmsISO 11607-1 Packaging Mechanical Integrity TestingISO 1184 Puncture Resistance of Flexible PackagingISO 1184 Puncture Resistance TestingISO 12048 Puncture Resistance of Packaging FilmsISO 12048 Puncture Resistance Testing of PackagingISO 12625-3 Mechanical Testing of Tissue and Crepe PapersISO 12625-3 Mechanical Testing of Tissue PapersISO 13820 Tensile Testing of Packaging MaterialsISO 13820 Tensile Testing of Plastic FilmsISO 16195 Compression Testing of Paper and BoardISO 16195 Compression Testing of Paper PackagingISO 1924-2 Tensile Strength of Paper and BoardISO 1924-3 Tensile Testing of Paper and BoardISO 20362 Compression Testing of PackagingISO 22000 Food Packaging Mechanical PerformanceISO 28780 Mechanical Properties of Flexible PackagingISO 28780 Mechanical Properties of Polymer FilmsISO 3035 Bursting Strength of Paper and BoardISO 3035 Bursting Strength Test of PaperboardISO 4593 Tensile Properties of Plastic FilmsISO 4593 Tensile Testing of FilmsISO 554 Puncture Resistance of PaperboardISO 554 Puncture Resistance Test of PaperboardISO 6383-2 Bending Resistance of PaperboardISO 6595 Tear Resistance TestingISTA 1A Distribution Simulation TestingISTA 1B Distribution Simulation with Drop TestISTA 1C Distribution Simulation and Drop TestingISTA 2A Integrity Testing of Packaging SystemsISTA 2B Simulation Testing of Transport PackagingISTA 2C Simulation Testing of Transport PackagingISTA 3A Vibration Testing for Transport PackagingISTA 3B Mechanical Shock TestingISTA 3D Shock and Vibration ConditioningISTA 3E Mechanical Shock and Vibration TestingISTA 3F Shock and Vibration Testing of PackagingISTA 5A Environmental Conditioning TestingISTA 5B Environmental Conditioning of PackagingISTA 6-A Edge Crush Resistance of Corrugated BoardISTA 6-B Edge Crush Test ValidationISTA 6-C Edge Crush Test EvaluationISTA 6-D Edge Crush Test for Corrugated FiberboardISTA 6-FE Edge Crush Test of Corrugated BoardISTA 6-FR Flat Crush Test of Corrugated BoardISTA 7B Environmental Conditioning for PackagingISTA 7D Thermal Conditioning of PackagingISTA 7E Environmental Conditioning and Mechanical TestingISTA 7F Thermal Conditioning and Mechanical Testing

ISO 11607-2 Packaging Integrity Testing Laboratory Testing Service Provided by Eurolab

ISO 11607-2 is a widely recognized international standard that governs the packaging integrity testing of sterile barrier systems for pharmaceutical and medical devices. The standard was developed by the International Organization for Standardization (ISO) in collaboration with industry experts and regulatory bodies.

The legal and regulatory framework surrounding ISO 11607-2 Packaging Integrity Testing testing is complex and varies depending on the region, country, or even industry sector. However, the primary objective of this standard is to ensure that packaging systems used for pharmaceuticals and medical devices meet specific requirements for sterility, barrier integrity, and leakage resistance.

International and National Standards

The relevant international standards governing ISO 11607-2 Packaging Integrity Testing testing include:

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

  • ISO 11607-2:2019 (Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and labeling processes)

    • National standards may vary depending on the region or country. For example:

  • EN 868-5:2008 (Sterilization indicators - Part 5: Packaging integrity testing)

  • ASTM F2096-01 (Standard Practice for Determination of Seal Integrity in Pouches Used to Contain Sterilized Medical Devices)

    • Standard Development Organizations

    Standard development organizations play a crucial role in developing and maintaining standards like ISO 11607-2. These organizations include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Evolution of Standards

    Standards evolve over time to reflect changes in technology, industry practices, or regulatory requirements. New standards are developed through a collaborative process involving industry experts, regulators, and standard development organizations.

    Standard Numbers and Scope

    The relevant standard numbers and scope for ISO 11607-2 Packaging Integrity Testing testing are:

  • ISO 11607-1:2016 - Requirements for packaging systems

  • ISO 11607-2:2019 - Validation requirements for forming, sealing, and labeling processes

    • Standard Compliance Requirements

    Industry sectors requiring compliance with ISO 11607-2 Packaging Integrity Testing testing include:

  • Pharmaceuticals

  • Medical devices

  • Biotechnology

  • Regenerative medicine

    • Consequences of non-compliance may include product recalls, regulatory fines, or even business closure.

    Business and Technical Reasons for Conducting ISO 11607-2 Packaging Integrity Testing

    This specific test is needed to ensure the integrity and safety of packaging systems used for pharmaceuticals and medical devices. Business reasons include:

  • Compliance with regulatory requirements

  • Product liability protection

  • Quality assurance and control

    • Technical reasons include:

  • Ensuring sterility and barrier integrity

  • Preventing leakage and contamination

  • Validating forming, sealing, and labeling processes

    • Consequences of Not Performing ISO 11607-2 Packaging Integrity Testing

    Failure to conduct this test may result in:

  • Product recalls

  • Regulatory fines

  • Business closure due to non-compliance

  • Damage to reputation and brand image

    • Industries and Sectors Requiring ISO 11607-2 Packaging Integrity Testing

    The following industries and sectors require compliance with ISO 11607-2 Packaging Integrity Testing testing:

  • Pharmaceuticals (sterile injectables, implants, etc.)

  • Medical devices (implants, contact lenses, etc.)

  • Biotechnology (vaccines, gene therapies, etc.)

  • Regenerative medicine (stem cells, tissue engineering, etc.)

    • Risk Factors and Safety Implications

    Non-compliance with ISO 11607-2 Packaging Integrity Testing testing poses significant risks to:

  • Patient safety

  • Product efficacy

  • Business reputation and brand image

    • Quality assurance and quality control aspects are critical in ensuring compliance with this standard.

    Competitive Advantages of Having ISO 11607-2 Packaging Integrity Testing Performed

    Conducting this test offers competitive advantages, including:

  • Compliance with regulatory requirements

  • Enhanced product safety and reliability

  • Improved quality assurance and control

  • Increased customer confidence and trust

    • Cost-Benefit Analysis of Performing ISO 11607-2 Packaging Integrity Testing

    The cost-benefit analysis of conducting this test includes:

  • Regulatory compliance costs (minimal compared to non-compliance)

  • Quality assurance and control benefits (enhanced product safety and reliability)

  • Competitive advantages (increased customer confidence and trust)

    • Step-by-Step Explanation of the Test

    1. Sample preparation

    2. Testing equipment and instruments

    3. Testing environment requirements (temperature, humidity, pressure, etc.)

    4. Sample preparation procedures

    5. Testing parameters and conditions

    6. Measurement and analysis methods

    7. Calibration and validation procedures

    8. Quality control measures

    Testing Equipment and Instruments

    The following testing equipment and instruments may be used to conduct ISO 11607-2 Packaging Integrity Testing:

  • Leak testers (e.g., helium leak detectors)

  • Pressure testing equipment (e.g., hydraulic pressure testers)

  • Moisture analysis equipment (e.g., dew point meters)

    • Testing Environment Requirements

    Testing environment requirements include:

  • Temperature control

  • Humidity control

  • Pressure control

    • Sample Preparation Procedures

    Sample preparation procedures involve preparing packaging systems for testing, including:

  • Sterilization

  • Sealing and labeling

  • Packaging system assembly

    • Testing Parameters and Conditions

    Testing parameters and conditions include:

  • Leak rate (in scc/min)

  • Pressure differential (in mbar)

  • Temperature (in C)

    • Measurement and Analysis Methods

    Measurement and analysis methods involve:

  • Data collection using testing equipment and instruments

  • Data analysis to determine compliance with standard requirements

    • Calibration and Validation Procedures

    Calibration and validation procedures ensure that testing equipment and instruments are accurate and reliable.

    Quality Control Measures

    Quality control measures include:

  • Regular calibration and maintenance of testing equipment and instruments

  • Continuous monitoring of testing parameters and conditions

    • Conclusion

    ISO 11607-2 Packaging Integrity Testing is a critical standard for ensuring the integrity and safety of packaging systems used for pharmaceuticals and medical devices. Understanding the standard, its requirements, and the consequences of non-compliance are essential for industries and sectors requiring compliance.

    By conducting this test, businesses can ensure regulatory compliance, enhance product safety and reliability, and improve quality assurance and control.

    Eurolab offers comprehensive ISO 11607-2 Packaging Integrity Testing services to help businesses ensure compliance with this standard.

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