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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. One common practice in the medical device industry involves using standard deviations to set the alert and action levels. Some approaches are more appropriate for overkill sterilization methods (e.g. ethylene oxide or steam) where others are more appropriate for bioburden-based sterilization methods (e.g. radiation). An important part of this process is a good definition for alert and action levels and understanding what should occur when each is triggered. Different sterilization types should require different numerical levels as well as specified follow up actions. This webinar provides insights to many facets involved in establishing alert and action levels for product and environmental bioburden. A thorough review of bioburden data can assist in selecting the best approach for the situation. The approaches discussed here have functioned well for a variety of product and sterilization types.