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Whitepaper

WHITEPAPER

Sterility Assurance for Single-Use Systems

This whitepaper provides an overview of assuring the sterility of single-use systems, which are common in pharmaceutical manufacturing.

Learn more about the authors below.

Martell Winters

Martell Winters

RM/SM (NRCM), CISS-RAD
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

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.

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