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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.

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.

This whitepaper was written by Martell Winters, Esther Patch, Wendy Wangsgard, Ashley Ferry and Harry Bushar.

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