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Thursday May 8, 2014 10:00-12:00

Selection of SAL, Evaluation of Bioburden Data, Alert and Action Levels and Bioburden Excursions

Introduction:  Understanding sterility assurance and bioburden data is essential to every sterilization method.  Of interest to medical device OEMs is the absolute necessity of a 10-6 sterility assurance level (SAL), use of “less-than” values with bioburden data and properly establishing alert and action levels.  These topics are applicable to all forms of sterilization (e.g. ethylene oxide, radiation, etc.).  Time for questions will be allotted for each discussion topic.

Selection of SAL for a Terminally Sterilized Product
•    Historical perspective on SAL
•    What impact can 10-6 SAL have on innovation?
•    ST67 concepts
•    Selection of SAL based on surgical site infections
Martell Winters, B.S., RM/SM(NRCM), Senior Scientist, Nelson Labs

Evaluation of “Less-Than” Values in Bioburden Data
•    When are less-than values used?
•    Potential issues with use of less-than values – particularly in radiation sterilization
•    Options for reducing less-than values
•    Calculating a more true value when using less-than numbers
Martell Winters, B.S., RM/SM(NRCM), Senior Scientist, Nelson Labs

Setting Alert and Action Levels for Product and Environmental Bioburden Counts
•    The Normal Distribution
•    What should be done at alert and action levels?  What should not be done?
•    Establishing alert and action levels for various sterilization methods
•    What is a bioburden spike?  An option based on normality/abnormality of the data.
Martell Winters, B.S., RM/SM(NRCM), Senior Scientist, Nelson Labs

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