RT Journal Article
SR Electronic
T1 Expanding the use of Moist Heat for Terminal Sterilization
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2023.012918
DO 10.5731/pdajpst.2023.012918
A1 Agalloco, James
YR 2024
UL http://journal.pda.org/content/early/2024/08/20/pdajpst.2023.012918.abstract
AB This publication reviews the background that shaped the execution of moist heat for terminal sterilization across the global healthcare industry. Despite the clear benefits to patient safety afforded by terminal treatments, narrow regulatory expectations and misinterpretation of scientific principles progress towards broader implementation has been minimal. This paper outlines a means to expanded implementation addressing the need for balancing processing delivering sufficient lethality to reliably destroy the pre-sterilization bioburden while preserving the essential quality attributes of the product. This is accomplished by delivering the correct sterilization process with adjustments to the time-temperature conditions.