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Method Development for Decontamination and Sterile Processing of Personal Protective Equipment (PPE)

Published Date: June 26, 2020

Throughout the COVID-19 crisis there has been a huge emphasis on bringing critical products to the healthcare market in a timely fashion.  This webinar will feature our collective learnings on required novel approaches to decontamination/sterile processing of items such as PPE. Manufacturers, regulators and end users have been pressed to develop new processing methods in a very accelerated fashion. It is important to understand when developing new methods that while accelerated or abbreviated test methods may be required, that does not obviate the need for holistic view ensuring all critical parameters are tested.

Participants Will Learn:

  • New process development on an accelerated timeline
  • Review of literature- understanding the study purpose and test conditions
  • Regulatory landscape around accelerated process and testing development
  • Value of multidisciplinary experience
  • Example of test method development- Disinfection protocols

Alpa Patel, B.S., RM (NRCM)

Principle Scientist, Nelson Laboratories, LLC

Alpa Patel is a certified microbiologist and has been part of the medical device industry for 17 years specializing in cleaning/disinfection and sterilization of reusable medical devices, endoscopes and validation of tissue disinfection or sterilization processes. Her current role as a principal scientist at Nelson, involves overseeing test method validations for reprocessing, writing standard test protocols (STP) and standard operating procedures (SOP) for reprocessing and other internal and globally related documents, providing technical consulting for the Reprocessing sections at Nelson Laboratories in Salt Lake City and globally. Alpa presents at Nelson Laboratories’ seminars, tradeshows, FDA, AAMI, and client facilities across the U.S and International sites.

Aaron DeMent

Vice President of Technical Services, Sterigenics U.S., LLC

Aaron DeMent has been with Sterigenics for over 20 years and currently serves as Vice President of Technical Services. In this capacity he oversees the Expert Advisory Services group who are responsible for validation protocol development and execution for the EO, E-Beam, Gamma and Nitrogen Dioxide Processes. In addition, the Technical Services group is responsible for exploring new sterilization technologies as well as the company EO Reduction Initiatives. Prior to his current position, he served as the Global Vice President Quality Assurance for Sterigenics. In this capacity he oversaw compliance to regulatory and quality standards for all of the Sterigenics sites globally. Aaron has held a variety of positions including Director, QA, GM, QA Manager, R&D Principal Sterilization Scientist, Sterilization Manager, Corporate Training Manager and QA/ Sterilization Consultant. Aaron has 28 years of experience in Medical Device, Pharmaceutical and Biologic Industries, much of it international. His primary experience is in sterilization where he has worked in all aspects of the business including QA, Operations, R&D and Distribution. Aaron has not only worked with Medical Devices but has worked on and developed sterilization methods using a variety of modalities for reusables, pharmaceutical, biologic and combination products. Aaron received his B.S. in Zoology from Cal State University at Long Beach. Aaron has also obtained ISO 13485 Lead Auditor certification, RSO training, 40 Hour OSHA Hazardous Waste training and Six Sigma certification along with numerous other industry specific trainings.

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