A recent feature in Plastics Today explores how production environments, regulatory classifications, and process validations shape the way medical packaging is designed and manufactured. I was grateful for the opportunity to share Dordan’s perspective on how we approach quality as an ISO 13485:2016 certified medical thermoformer.
Quality control always begins with the customer’s requirements. Device classification, intended use, sterilization method, and contamination sensitivity determine the level of controls a package needs. This also dictates the production environment—whether it can be produced in a standard facility or must run in an ISO Class 8 cleanroom, which is considered the gold standard for sterile barrier systems.
For FDA Class II and III devices—like surgical trays, orthopedic kits, and implantables—cleanroom manufacturing is typically required. These controlled environments allow us to leverage precision tooling and advanced forming equipment to achieve tight dimensional tolerances, optimized material distribution, and consistent seal flanges that maintain the sterile barrier.
Producing in a cleanroom also means more rigorous quality protocols: First Article Inspections (FAI) are performed for every job, with First Article Validations (FAV) standard for cleanroom runs. Advanced validations (IQ/OQ/PQ, PPAP) and CPK studies with automated optical inspection confirms the process is stable and capable of producing parts within specification; and robust documentation ensures safety and regulatory compliance.
Environmental controls are another critical part of the process. ISO Class 8 cleanrooms are continuously monitored for airborne particulates, bioburden, temperature, and humidity, with strict gowning, sanitation, and material-handling protocols to minimize risk. Compared to standard manufacturing, cleanroom production involves more frequent inspections, tighter process monitoring, and higher traceability—all of which translate to safer, more reliable medical packaging.
Click here for the full Plastics Today article.
