RT Journal Article
SR Electronic
T1 The Bugs Don't Lie
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2019.009894
DO 10.5731/pdajpst.2019.009894
A1 Agalloco, James P
YR 2019
UL http://journal.pda.org/content/early/2019/09/13/pdajpst.2019.009894.abstract
AB Sterilization is a critical process in the preparation of many drug products. Its execution and validation are addressed in numerous regulatory, pharmacopeial and industry documents. EMA Annex 1: Sterile Medicinal Products stands alone in giving clear preference to physical measurements over those obtained from biological indicators. This paper reviews principles behind sterilization processes outlining the differences between physical and biological measurements, as well as their relationship to each other. The assumptions associated with the use of physical measurement are explored and their derivation from microbiological results is traced with the intent of re-affirming the primacy of biological evidence. The arguments and objections to the use of biological indicators in sterilization are reviewed and deconstructed.