The editorial staff at MPOmag.com recently consulted with Nora Crivello, WESTPAK’s president & CEO, while preparing the article “Examining Device Packaging and Sterilization Options,” published on June 02, 2021.
Nora offered her perspectives regarding ethylene oxide (EO) and alternative technologies for use in the sterilization of packaged medical devices. Peers Roy E. Morgan, general manager at Eagle Medical Sterilization Packaging, Dan B. Floyd, microbiologist and medical device regulatory specialist for DuPont Tyvek Medical & Pharmaceutical Packaging, and others, were interviewed as well.
Referring to the European Medical Device Regulation (MDR), Nora remarked that “New rules requiring more technical documentation and labeling will have ripple effects on packaging and validation efforts. This includes adherence to and evidence of package testing to validated test methods.”
Also, “Because of the complexity and resources required to complete TMVs [Test Method Validations], many in-house labs have outsourced validated testing to independent laboratories who have completed this work,” said Nora.
To learn more about Test Method Validations (TMVs) for medical device package tests at WESTPAK, reference these two presentations by Andy Thomas, Lab Manager at our San Diego, CA-based testing facility, located in Past Webinars:
• Validated Testing for Medical Device Packaging – Jan 2021
• Test Method Validation at WESTPAK – Apr 2021