RT Journal Article
SR Electronic
T1 Wanted: Dead or Alive
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 458
OP 464
DO 10.5731/pdajpst.2020.011478
VO 75
IS 5
A1 James P. Agalloco
YR 2021
UL http://journal.pda.org/content/75/5/458.abstract
AB Sterilization validation practices in the United States rely heavily on the destruction of microorganisms to establish that sufficient lethality has been delivered. The objective in many instances is demonstration of the poorly defined attainment of “overkill” throughout the load. The complete destruction of resistant spore formers is assumed to support the attainment of a minimum probability of a nonsterile unit (PNSU). In reality, the absence of recoverable microorganisms in sterilization cycle development and validation does not allow for accurate PNSU determination. This article outlines how a strategy inspired by that used for ISO 11137-2, VDMAX, with positive results can be used to fully support sterilization cycle efficacy. This article is intended to spark interest in a potentially novel approach to sterilization cycle development and can be refined once sufficient experience has been gained with it.