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Sterilization and Sterility Verification of Single-Use Systems

Published Date: March 14, 2023

Single-use systems (SUS), sometimes referred to as bioprocessing systems, have increased in popularity due to their advantages over the stainless-steel pipes and tanks. Along with these advantages there are also complications in the form of determining an appropriate radiation sterilization dose (for the manufacturer) and appropriately “verifying” sterility (for the manufacturer or the end user).

In addressing both of these issues, occasionally approaches are taken that are either incorrect from a scientific perspective or that are unnecessarily arduous. This webinar explores options to simplify and correctly address both issues.

Watch this webinar to learn the following:

  • Options already present in the standards that can simplify determination of a radiation sterilization dose
  • Appropriate ways to verify sterility for single-use system subassemblies or finished products
  • Available and upcoming resources for sterilization validation and sterile verification of single-use systems

This webinar is ideal for the following people:

  • Sterility-assurance personnel
  • Validation personnel
  • Sterilization microbiologists
  • Quality-assurance personnel
  • Product engineers

Learn more about the presenters below.

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.


Adam Staples

Study Director, Antimicrobials and Filtration

Adam has worked for Nelson Labs for nearly 10 years. He has worked in the Sterility Assurance group as a testing analyst and a study director. He is currently working in the antimicrobials and filtration section, overseeing kill time, microbial growth, tissue log reduction, and disinfection validations. He received his Bachelor of Science degree in microbiology from Weber State University.

Complete the form below to access the webinar.