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.
Requirements
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
