Medical device package testing case study

摘要

Say you're a packaging engineer and your package-testing mission involves a surgical device made of high-carbon steel that's corrosion-prone, requires gamma radiation, works with current thermoform/fill/seal machinery, offers a five-year shelf life, and must be cost-effective. What do you do? A good first step would be to check the regulatory framework, particularly ISO 11607, "Packaging for terminally sterilized medical devices, Part 1: Requirement for materials, sterile barrier systems and packaging systems," and "Part 2: Validation requirements for forming, sealing, and assembly processes." Available online, both are from the International Organization for Standardization (ISO, www.iso.org). Another good resource is "Device Advice: Comprehensive Regulatory Assistance" from the U.S. Food and Drug Administration. The regulatory recommendations were suggested by Karen Greene of Life Packaging Technology, LLC (www.lifepackagingtechnolo gy.com), a customized packaging engineering services firm. Greene also serves as the subcommittee chair for the Institute of Packaging Professionals (www.iopp.org) Medical Device Packaging Technical Committee, or MDPTC (see sidebar), she discussed the anonymous corrosion-prone device case history during a Nov. 15 Webinar entitled, "Developing and Validating Barrier Shelf Life for Medical Device Packaging," presented by loPP and sponsored by Healthcare Packaging.