Packaging Validation Best Practices
Jeff Barrett, CEO of J-Pac Medical, explains the complexities of ISO 11607 packaging validation for sterilized medical devices, emphasizing that over a third of validations fail transit testing due to a lack of understanding regarding shipping modes. He details how companies can avoid costly 510(k) delays by conducting feasibility testing, using worst-case scenarios for sterilization, and managing labeling risks, which account for 40% of FDA recalls. Barrett highlights that sterilization validations can cost $40,000-$80,000 and take 16-20 weeks, urging engineers to integrate packaging design early in the process to prevent revalidation issues as companies scale.