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LIVE WEBINAR

Radiation Microbiology in Pharmaceutical Products

August 12, 2026

2:00 pm ET

Martell Winters, Chris Hardman and Christine Walton

Microbiological testing on pharmaceutical products can sometimes be confusing, especially when dealing with sterilized components or a terminally sterilized pharmaceutical product or combination product. Standards and test methods are provided by ISO as well as USP/EP and knowing which one to follow and when is not well described in industry documents. In this webinar presented by the International Irradiation Association (iia) we will explore the purposes behind the various test methods and approaches, the testing associated with a contamination control strategy, and how to properly combine the ISO and USP/EP test methods in the lifecycle of a pharmaceutical product.

The webinar will include a live Q&A session.

Presenters:

  • Arthur Dumba (Host) – General manager, International Irradiation Association (iia)
  • Chris Hardman – Department Scientist, Nelson Labs
  • Christine Walton – Senior Scientist, Nelson Labs
  • Martell Winters – Director of Science, Nelson Labs
Martell Winters

Martell Winters

RM/SM (NRCM), CISS-RAD
Sr. Manager, Scientific Business Development

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.

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Chris Hardman

Department Scientist

Chris Hardman is a department scientist in the ISO Bioburden and Radiation Department, where he combines his expertise in radiation sterilization with a passion for customer engagement. In this role Chris works closely with customers to share his knowledge and help optimize bioburden testing and radiation sterilization testing processes. He also focuses on scientific advancements, procedure ownership, and training, while serving as the department’s acting subject matter expert.

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Christine Walton

Senior Scientist

Christine Walton is a senior scientist with nearly two decades of laboratory experience supporting product quality and regulatory compliance in the medical device and pharmaceutical industries. She is highly skilled in microbiological consulting and testing per USP <60>, <61>, and <62> standards, along with environmental and water monitoring. Her expertise extends to biocompatibility and endoscope reprocessing programs, with complementary experience in bioburden testing. Christine has provided technical consultation to the FDA and CDC on endoscope microbiological screening and is recognized for her ability to align scientific precision with regulatory expectations.

Arthur Dumba

iia General Manager

Arthur has extensive experience of the irradiation and healthcare industries. As a microbiologist, he joined Isotron (now part of STERIS) where he was involved in regulatory affairs and quality assurance. After leaving Isotron, his experience with sterilisation technologies led to him becoming a sterilisation consultant supporting various medical device companies across Asia, Europe and the USA with sterilisation processing and radiation dosimetry. Additionally, Arthur has been the driving force behind the creation of the Society for Sterility Assurance Professionals (SfSAP). Arthur joined iia in July 2023, and now leads the operational team as General Manager.