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Process Validation

January 13, 2016

FDA Safety Notice: Lubricious Coating Separation on Intravascular Devices

Recently the US FDA issued a safety notice on Lubricious Coating Separation from Intravascular Medical Devices. The FDA wants to make health care providers aware of the possibility that hydrophilic and/or hydrophobic coatings may separate (e.g., peel, flake, shed, delaminate, slough...

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November 13, 2015

Tribute to Dr. Scott Sutton; Review of Bioburden Contamination Control

Scott Sutton, PhD, was a well-respected and influential thought leader in the microbiology industry. He was a consultant and trainer in CGMP, investigations, environmental monitoring, and contamination control for pharmaceutical companies for over 30 years. He gave many presentations on...

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October 15, 2014

Nelson Laboratories Scientist Provides Clarification on Tissue Bank Cleaning Validations

Nelson Laboratories, Inc. Alpa Patel, senior scientist in healthcare reprocessing, presented at the annual American Association of Tissue Banks (AATB) meeting last month on the topic of Equipment Cleaning and Disinfection Validations, something she calls, “the tissue industry’s compliance challenge.”...

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May 15, 2014

Importance of Cleaning and Sterilization Validations, Even When they may Not be Required

Department Scientist-Healthcare Reprocessing I recently attended the 10th Annual FDA and Changing Paradigm for HCT/P Regulation Conference, with my colleague Wendy Wangsgard, Department Scientist, Bioburden. We presented topics of interest that have surfaced the validation realm, in addition to learning...

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May 14, 2014

AAMI Sterilization Standards Meeting Update on Processing of Reusable Medical Devices

On April 14-16, 2014, I attended the Association for the Advancement of Medical Instrumentation (AAMI) semi-annual Sterilization Standards Meeting. These Association meetings, and the standards discussed during them, have a major impact on medical device manufacturers, testing facilities, HCF managers,...

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