Understanding Process Validation in the Production of Medical Plastic Parts

FDA’s 21 CFR Part 820 — Quality System Regulation (QSR) has not been updated since it was first released in 1996 . . . until now. Are you ready?

FDA proposed aligning its regulations with ISO 13485: 2016, the international quality management system standard, in February 2022. Some time this year, the agency will update and release its QSR requirements, and the medical device manufacturing supply chain will need to be prepared. Vinny Sastri, president of Winovia, a consultancy helping the medical device industry comply with quality system regulations, will speak to this and broader issues involving process validation for medical device plastics and products at the forthcoming MiniTec conference track presented by the Society of Plastics Engineers (SPE). The track is part of the Informa Markets Engineering (IME) West event, which includes the co-located Medical Design & Manufacturing (MD&M) and Plastec West trade shows and associated conferences, coming to the Anaheim Convention Center in Anaheim, CA, on Feb. 6 to 8, 2024.

Mind the gaps

Part of a panel at the conference discussing the characterization and validation of medical devices, Sastri stressed to PlasticsToday the importance of the update to 21 CFR Part 820, which, as defined by FDA, covers the “design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.” The update, notes Sastri, “will be aligned with and reference most sections of ISO 13485:2016. It will replace the current regulation as it stands. Companies need to make sure that they meet the requirements for the validation of processes per ISO 13485:2016. Any identified gaps must be addressed.”

Who’s responsible?

Process validation, in the broadest sense, demonstrates that the control of manufacturing processes consistently produces devices that are safe and effective, Sastri explains. While the “company that owns the registration to the medical device — the OEM — has the responsibility to comply with medical device regulations and standards, it will need to control suppliers whose products and raw materials have a significant effect on patient and user safety.” Depending on the risk of the supplied part or raw material — when used with implants, for example — the OEM may require a Tier 1 supplier to apply appropriate controls over its suppliers, Sastri adds. “Over the last 25 years, scores of deaths and injuries resulted from the lack of control over suppliers,” says Sastri, who is the author of Plastics in Medical Devices: Properties, Requirements and Applications, published by Elsevier (London).

How a burden becomes a business opportunity

While suppliers to the medtech industry have been known to grouse about “overly burdensome” regulations, there is a business argument to be made for diligent compliance. “Suppliers to the medtech industry who demonstrate control of their products and processes can leverage this competency to continue to make inroads and increase their customer base, leading to increased sales,” says Sastri. The proof, incidentally, is on the MD&M West show floor, where top-tier suppliers put their quality systems credentials front and center in their booth. It clearly represents a competitive advantage.

I asked Sastri for three key takeaways he hopes to leave conference attendees with at the session scheduled for Feb. 6 at 1:30 p.m. “An understanding of the basic regulatory requirement and principles of process validation,” topped the list. Moreover, attendees will see that understanding applied to a practical example and will walk away with the ability to “identify how to demonstrate compliance to process validation within an organization or company,” Sastri adds.

A leading industry expert in FDA and ISO quality management systems and a certified Six Sigma black belt, Sastri has a strong track record in leading, managing, establishing, and implementing quality initiatives into client organizations around the world.

Joining him on the panel at the conference are Ali Ashter, CEO, Ashter Enterprise LLC, and a delegation from Cambridge Polymer Group including company president Stephen Spiegelberg; Becky Bader, associate director of chromatography; Jamiee Robertson, research scientist; and Michael Young, senior research chemist.