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Whitepaper

WHITEPAPER

Establishing Bioburden Alert and Action Levels

Most national and international standards regarding bioburden, sterilization, or environmental testing refer to establishing alert and action levels to assist in demonstrating continued control over a process or product.

The standards sometime include guidance on evaluating the data but seldom go any further. Oftentimes, what information is provided in a standard is more descriptive rather than prescriptive, which is necessary in a national or international standard.

Martell Winters

Martell Winters

BS, 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.

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