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Author: Wendy Mach





August 7, 2019

Selecting & Justifying Sample Sizes: Where to Begin?

Within our industry, we have seen several approaches to selecting samples sizes, this paper will not cover all of the approaches, but it is a guide to give medical device manufacturers and pharmaceutical companies a good starting point for determining...

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April 24, 2018

Healthpack Conference 2018 Wrap Up

This year’s Healthpack® Conference included a wide range of topics and speakers that covered everything from the past, present, and future of the packaging industry. With a majority of the attendees being from both the medical device manufacturers and material...

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March 11, 2016

Understanding Validation for Verification Dose Maximum Sterilization

Lower sterilization doses are now available with the VDmax method of validation and may be used as a viable alternative to providing assurance of sterility without using the large sample sizes required by other methods.

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February 9, 2014

What You’ll Learn at the MD&M West Nelson Laboratories Classroom on Packaging Test Methods for Validation of Sterile Barrier Materials

Agenda: Wendy Mach will present various test methods for validating the sterility of medical device packaging at the 2014 MD&M West Conference. Wendy is a Section Leader at Nelson Laboratories in Salt Lake City, Utah. Her presentation will include: How...

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October 1, 2012

Regulatory Considerations and Revalidation Tests for Managing Change in Packaging Materials or Critical Supplies

In light of recent material changes within the medical device packaging industry, it is imperative manufacturers respond to triggers built into their change management process so they can (1) assess the impact a change in materials or processes has on...

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