RT Journal Article
SR Electronic
T1 The Boil Test—Strategies for Resistance Determination of Microorganisms
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 566
OP 573
DO 10.5731/pdajpst.2017.008532
VO 72
IS 6
A1 Agalloco, James
A1 Tidswell, Edward C.
YR 2018
UL http://journal.pda.org/content/72/6/566.abstract
AB The terminal sterilization of drugs and devices is the most appropriate means of assuring patient safety in terms of infection prevention. Adoption of terminal sterilization processes requires a supporting and thorough program for control and monitoring of bioburden, especially if a parametric release program of sterilization is desired. Such a control program should necessarily assess and evaluate the associated bioburden (primarily spores), which may resist inactivation and challenge the sterilization cycle. The bioburden resistance can be evaluated by several means and procedures (e.g., the boil test); however, these procedures should be designed and implemented taking into consideration the nature of the spore and spore recovery. This short review describes the application of moist heat resistance for the terminal sterilization of drugs.LAY ABSTRACT: The terminal sterilization of drugs and devices is the most appropriate means of assuring patient safety in terms of infection prevention. Adoption of terminal sterilization processes requires a supporting and thorough program for control and monitoring of bioburden, especially if a parametric release program of sterilization is desired. This short review describes the application of moist heat resistance for the terminal sterilization of drugs.