It is widely known that test procedures published by organizations such as the United States Pharmacopeia (USP), American Society of Tests and Measurements (ASTM), and the International Organization of Standard (ISO) are critical to the manufacture, qualification, and approval of FDA regulated products. The difficulty with many of these procedures usually comes in the interpretation stage – “what exactly needs to be done”. Many of these procedures make reference to complimentary requirements that may be published under a separate document. In today’s fast paced, real time environment, reading and understanding a twenty-five page procedure that includes complicated test directions and multiple external references can be time consuming and lead to misinterpretation. In this article, we will attempt to provide a “laymen’s” overview of the key components to the ISO 11607 testing procedure. While a review a this article may offer more understandable insight to the key parts of the ISO 11607 testing requirement, the true key to success if your company needs to meet this requirement, centers on working with vendors who have experience and expertise in this specific area of testing.
ISO 11607 is the principle guidance for validating terminally sterilized medical device packaging. Published in 2006, the 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.” The issuance of ISO 11607 testing improved the flow of package qualification and process validation by defining/harmonizing four key terms used throughout both parts of the standard:
- Sterile Barrier System (SBS): The minimum packaging that prevents ingress of microorganisms and allows aseptic presentation at the point of use.
- Preformed Sterile Barrier System: The sterile barrier system that is supplied partially assembled for filling and final closure or sealing, e.g., pouches, bags, and open reusable containers.
- Protective Packaging: The packaging configuration designed to prevent damage to the sterile barrier system and its contents from the time of their assembly until the point of use.
- Packaging System: The combination of the sterile barrier system and protective packaging.
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 testing requires medical device manufacturers to demonstrate the efficacy of their proposed sterile barrier packaging design. 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 the field. Package strength testing and package integrity testing provide the means to evaluate the packaging after such exposure.
In addition, there are many referenced to specific physical tests required by ISO 11607 testing on your SBS packaging. This list of test that may be applicable include, but are not limited to:
- Visual Inspection: ASTM F1886, Standard testing method determining integrity of seals for medical packaging by visual inspection
- Internal Pressurization: ASTM F2096, Standard testing method detecting gross leaks in porous medical packaging by internal pressurization (Bubble test)
- Vacuum Leak: ASTM D3078, Standard testing method used for determination of leaks in flexible packaging by bubble emission
- Integrity/Dye Penetration: ASTM F1929, Standard testing method detecting seal leaks in porous medical packaging by dye penetration
- Integrity/Dye Penetration: ASTM F3039, Standard testing method detecting seal leaks in nonporous medical packaging by dye penetration
- Seal Strength: ASTM F88, Standard testing method used for seal strength of flexible Barrier materials
- Seal Strength: ASTM F1140, Standard test methods for failure resistance of unrestrained and non-rigid packages for medical application
- Seal Strength: ASTM F2054, Standard method for burst testing of flexible package seals using internal air pressurization within restraining plates
- Tensile Properties: ASTM D882, Standard test method used for tensile properties of thin plastic sheeting
- Tear Resistance: ASTM D1922,Standard testing method for propagation tear resistance of plastic film and thin sheeting by pendulum method
- Puncture: ASTM D3420, Standard test method for pendulum impact resistance of plastic film
- Puncture: ASTM F1306, Standard test method for slow rate penetration resistanceof flexible barrier films and laminates
- Puncture: ASTM D1709, Standard test method for impact resistance of plastic film by free-falling dart method
- Performance: ASTM D4169, Standard Practice for Performance Testing of Shipping Containers and Systems
- Aging: ASTM F1980, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Navigating and understanding ISO 11607 testing and the ancillary procedures that may be required for compliance can be a daunting task. Hopefully this general overview provides some insights to the key concepts of the procedure. As noted, the key to successful compliance is utilizing those people or organizations that have the proven experience in this area.