By Wendy S. Mach, Packaging Section Leader, B.C., RM (NRCM), CQA(ASQ)
In Part 1 of our two part series on packaging, we wrote about the desire many medical device and packaging material manufacturers’ have to find ways to be more environmentally friendly and cost effective during these times of green initiatives and economic uncertainty.
Today we look at the various tests needed to validate medical device packaging. Whether for an initial validation or for a re-evaluation, there are a minimum of three categories that must be evaluated to validate a packaging process: Integrity, Strength and Microbial Barrier. Within each category there are a few different tests to choose from.
By Todd D. Hillam, SM(NRCM) Aerobiology Section Leader and Sarah Smit, Study Director at Nelson Laboratories
Surgical face masks are subject to FDA and other regulatory requirements and approval prior to being marketed and sold in public. Some of the guidance and standards that will help manufacturers meet these requirements are,
- FDA guidance: Surgical Masks – Premarket Notifications [510(k)] Submissions
- ASTM F2100 in the U.S.
- EN 14683 in Europe
by Michael Neilson, Pharmaceuticals Department Manager, BS, RM(NRCM), CQPA
Hard surface disinfectants go through a series of tests outlined in the AOAC International standard in order to be classified as bactericidal, fungicidal, tuberculocidal, virucidal or sporicidal. Although the AOAC tests hold disinfectants to a high standard for determining efficacy against microorganisms, they are limited in the fact that they do not simulate real use conditions. It is therefore crucial that manufacturers who use these products to disinfect clean rooms and other controlled manufacturing environments, perform validation studies that support their in-house disinfection program.
The American Society of Quality (ASQ) recently certified several employees at Nelson Labs. ASQ advances the professional development, credentials, knowledge and information services on behalf of its members.