White Paper: Medical
Establishing Bioburden Alert & 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.
One common practice in the medical device industry involves using standard deviations to set the alert and action levels. Other practices refer to bioburden values which are provided as a limit in a table, for example, a radiation sterilization dose substantiation table. Even though these practices can work well, it is important to understand the different concepts being employed in taking different approaches. 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).
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