Medical Device Package Validation – ISO 11607
An independent, third party laboratory, Whitehouse Laboratory’s ISTA and ISO 17025 certified package testing laboratory provides medical device package validation testing to ISO 11607. The principle guidance for validating terminally sterilized medical device packaging is ISO 11607.
ISO 11607 is divided into two parts – Part 1, “Requirements for Materials, Sterile Barrier Systems and Packaging Systems” and Part 2, “Validation for Forming, Sealing, and Assembly Processes.” ISO 11607 improved the flow of package qualification and process validation by defining/harmonizing four key terms used throughout both parts of the standard:
For sterile barrier packaging systems, ISO 11607 Part 1 Design and Development outlines four key requirements:
- ISO 11607 Stability Testing: Real Time Aging and Accelerated Aging (ASTM F1980) to demonstrate the sterile barrier system maintains integrity over time for the anticipated shelf life of the product.
- ISO 11607 Performance Testing: ISTA and ASTM distribution simulation to demonstrate that the packaging system provides protection though the hazards of handling, distribution and storage.
- ISO 11607 Package Strength Testing: Physical tests to demonstrate the mechanical performance of the sterile barrier system.
- ISO 11607 Package Integrity Testing: Physical tests to demonstrate the sterility and integrity of the sterile barrier system.
ISO 11607 requires medical device manufacturers to demonstrate the efficacy of their proposed sterile barrier packaging . Environmental conditioning, accelerated aging and distribution simulation provide a controlled means to expose a packaging system to the anticipated environmental and dynamic stresses that the packaging system may encounter in field. Package strength testing and package integrity testing provide the means to evaluate the packaging after such exposure.
Interpreting ISO 11607 can be challenging. Whitehouse Laboratories is happy to assist customers to better understand the testing, the available options and how to execute packaging validation projects on time and on budget. We routinely execute many physical tests required by ISO 11607 on your sterile barrier packaging. Tests include, but are not limited to:
ISO 11607 Package Validation Tests
- Visual Inspection: ASTM F1886, Determining integrity of seals for medical packaging by visual inspection
- Internal Pressurization: ASTM F2096, Detecting gross leaks in porous medical packaging by internal pressurization (Bubble test)
- Vacuum Leak: ASTM D3078, Determination of leaks in lexible packaging by bubble emission
- Integrity/Dye Penetration: ASTM F1929, Detecting seal leaks in porous medical packaging by dye penetration
- Integrity/Dye Penetration: ASTM F3039, Detecting seal leaks in nonporous medical packaging by dye penetration
- Seal Strength: ASTM F88, Seal strength of flexible Barrier materials
- Seal Strength: ASTM F1140, Failure resistance of unrestrained and non-rigid packages for medical application
- Seal Strength: ASTM F2054, Burst testing of flexible package seals using internal air pressurization within restraining plates
- Tensile Properties: ASTM D882, Tensile properties of thin plastic sheeting
- Tear Resistance: ASTM D1922, Propagation tear resistance of plastic film and thin sheeting by pendulum method
- Puncture: ASTM D3420, Pendulum impact resistance of plastic film
- Puncture: ASTM F1306, Slow rate penetration resistanceof flexible barrier films and laminates
- Puncture: ASTM D1709, Impact resistance of plastic film by free-falling dart method
- Performance: ASTM D4169, Standard Practice for Performance Testing of Shipping Containers and Systems
- Performance: ISTA 1, 2 and 3 Series Distribution Tests
- Aging: ASTM F1980, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Whitehouse Laboratories is happy to assist customers to better understand the testing requirements, the available test options and how to execute packaging validation projects on time and on budget.
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