Medical device packaging must protect the sterile barrier through production, sterilization, storage, and distribution. ProTech Design works with device teams on packaging process validation under ISO 11607-2, including forming, sealing, and assembly processes for terminally sterilized packaging. We bring 45+ years of medical device packaging experience to this work.
ISO 11607-2 covers validation of the processes used to form, seal, and assemble terminally sterilized medical device packaging. The aim is a repeatable process that produces a sterile barrier system meeting its requirements. Testing a finished package provides performance evidence, but it does not validate the process that produced it.
Our work can include equipment and process validation, sterile barrier integrity, and records that trace the work. Package materials, equipment, process settings, and sterilization method inform the validation plan.
Packaging validation may include performance testing, accelerated or real-time aging, distribution simulation, seal strength, and package integrity testing. Each method addresses a different question about the packaging system.
Bubble emission testing checks for gross leaks; peel and burst tests assess seal strength. Visual inspection can identify visible defects. We discuss relevant tests alongside process validation so the evidence fits the package and the question.
ProTech provides validation documentation to support regulatory submissions and audits. Project records can identify the process, test methods, and acceptance criteria for the agreed work, along with resulting data and reports.
Packaging testing and validation are available through our in-house laboratory. When additional testing is needed, ProTech also works with outside testing agencies. The project scope identifies who performs each test and which records are provided.
Share the device and packaging format, intended sterilization method, and whether the work concerns a new design or a change to an existing process. Existing validation documents and test results help our team understand what is established.
We can discuss the validation work, testing, and documentation for the project. Timing, sample quantities, and commitments are set in the agreed scope because they depend on the package and methods selected.
Answers to common questions about process validation and packaging tests.
No. ISO 11607-2 addresses validation of forming, sealing, and assembly processes for terminally sterilized packaging. Package integrity testing evaluates the packaging system and complements process validation; it does not replace it.
Yes. Share the available reports and explain which package and process they concern. Our team can consider them when discussing the testing and validation scope.
Share your package design, sterilization method and existing test results with our laboratory team.
