Regulatory Requirements

Background

Both the FDA and international regulatory bodies are focusing increasing emphasis on compliance with ISO 11607; Packaging for terminally sterilized medical devices and EN 868-1; Packaging Materials and systems for medical devices which are to be sterilized. These standards define the test requirements necessary to insure that the terminally sterilized package/device will maintain its design performance over the intended life of the product and will not degrade as a result of sterilization, shelf life, transport or storage.

Scope of ISO 11607

This International Standard specifies the requirements for single-use materials and reusable containers used for packaging of terminally sterilized medical products, whether produced industrially or in health care facilities. It also outlines principal requirements for packaging process development and validation for the manufacturer of terminally sterilized medical products. ISO 11607 does not define sampling plans or the number and duration of replicate test runs.

ISO 11607 allows either the producer or the manufacturer to conduct a formal qualification to determine if a potential packaging material meets the expected performance requirements. Once a material has been determined to adequately meet the performance requirements, product specifications may be established by the producer, manufacturer or a regulatory body. From that point in time, compliance qualification of the material can be conducted to demonstrate that the material meets these stated requirements.

The development and validation of packaging operations are crucial in order to assure package integrity. There should be a documented process validation program demonstrating the efficacy and reproducibility of all packaging processes.

The microbial barrier properties of the selected packaging material(s), together with suitable forming and sealing, are critical for assuring package integrity and product safety. As long as a formal packaging validation study has not been conducted, the barrier properties of materials should be evaluated separately from the effectiveness of the forming and sealing processes. Package validation put simply, is a series of tests that simulate the environmental and mechanical stresses that the packaged product may be subjected to during its useful life expectancy. Both the package and the product must be tested after being subjected to these stresses. (MPT only tests the packaging components; the customer is responsible for conducting functional testing on the actual device/product after MPT returns the samples.) These test categories include:

• Accelerated aging - shelf-life studies;
• Simulated transportation - shock, compression and vibration studies;
• Package Seal Strength Testing - peel and burst testing.
• Package Integrity Testing - dye penetration and bubble emission testing