James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

The PNSU, probability of a non-sterile unit, is crucial to determining process conditions.  However, the concept is often misapplied. 

	Sterile processing expert Jim Agalloco explains how the proper application of a biological indicator can guide the development of an effective sterilization process.
	 

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Pharmaceutical Technology-05-15-2017

Pharmaceutical Technology

Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.

Kill the Bioburden, Not the Biological Indicator