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Key Elements of a Sterility Assurance Program

Published Date: October 2, 2020

This presentation will provide aspects of a sterility assurance program for a pharmaceutical product. Sterility assurance begins at the early stages of product development and follows through the entire product lifecycle. The concepts will be discussed in the context of a product lifecycle including examples of how they might be applied.

Topics specifically addressed will be:

  • Product and packaging
  • Manufacturing process design
  • Evaluation and selection of materials
  • Microbiological process controls and testing
  • Sterility assurance validation and maintenance
  • Change control

This webinar is part of our pharma webinar series “Pharmaceutical Sterility Assurance, Contamination Control, and Extractables & Leachables.” These webinars, presented by Expert Advisors from Sterigenics, Nelson Labs and Noxilizer are designed to bring you insights into the latest developments and innovations in Pharma Sterilization (Sterilization technologies & sterility assurance), Extractables & Leachables testing (Instruments & techniques & regulatory requirements), as well as Bacterial Endotoxin testing.

Webinars in this series include:

Martell Winters

Martell Winters

Scientific Competency Expert

Martell Winters is a specialist microbiologist (NRCM) and a radiation specialist (AAMI). He has been at Nelson Labs for 24 years and spent his earlier years working in the Radiation Sterilization group, responsible for bioburden testing and radiation validation studies. His specialties include microbiological process validation and radiation sterilization of medical devices, allograft tissue, and pharmaceutical products.


Aaron Dement

Vice President of Technical Services

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.

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