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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