Product Development
For sterile medical devices, the packaging system is part of the device — it maintains sterility through distribution and allows aseptic presentation in the clinical setting. A packaging validation that doesn't satisfy ISO 11607 requirements will generate a deficiency in your 510(k) or PMA review.
Validate Your Packaging SystemPackaging Validation
ISO 11607 establishes the requirements for materials, sterile barrier systems, and packaging systems used to maintain sterility of terminally sterilized medical devices. The standard has two parts: Part 1 covers requirements for materials, sterile barrier systems, and packaging systems; Part 2 covers validation requirements for forming, sealing, and assembly processes. Together, they define the complete packaging validation program that FDA expects for sterile device submissions.
FDA's recognition of ISO 11607 means that packaging validation documentation in a 510(k) or PMA submission is evaluated against the ISO standard. A packaging validation that was conducted at an accredited test lab but against a protocol that doesn't address all ISO 11607 requirements — for example, that omits distribution simulation testing or doesn't validate the seal process to defined parameters — will generate an Additional Information request. We develop packaging validation protocols against the ISO standard explicitly, with each protocol requirement traced to the corresponding ISO 11607 requirement.
Package integrity testing under ISO 11607 and the ASTM standards referenced in the standard evaluates whether the sterile barrier system maintains integrity through the intended use life and distribution conditions. Key test methods include peel strength testing (ASTM F88) to evaluate seal strength and peel characterization, seal burst testing (ASTM F1140/F2054) to evaluate seal strength under pressure, dye penetration testing (ASTM F1929) to detect gross seal defects, and microbial challenge testing or surrogate testing to evaluate microbial barrier function.
The specific tests required depend on the packaging materials, sterile barrier configuration, and sterilization method. Tyvek-Mylar pouches, Tyvek trays, and form-fill-seal packaging systems each have different test requirements and different process validation considerations. Accelerated aging under ASTM F1980 is commonly used to support shelf-life claims before real-time aging is complete. We work with accredited packaging test labs to develop testing programs matched to the specific packaging system and submission timeline.
ASTM D4169 distribution simulation testing evaluates whether the packaging system can survive the mechanical stresses of the supply chain — vibration, drop, compression, and atmospheric pressure — without compromising package integrity. A device that arrives at the clinical site with a compromised package is a regulatory and patient safety event regardless of whether the device itself is damaged. Distribution simulation is required for devices shipped outside of controlled conditions, which includes essentially all commercial distribution. We scope distribution simulation testing to the device's specific distribution profile and connect the test results to the sterile barrier integrity assessment.
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Packaging deficiencies in FDA submissions are preventable. We develop packaging validation programs designed to satisfy ISO 11607 requirements and survive FDA reviewer scrutiny.