RT Journal Article
SR Electronic
T1 Physical and Chemical Monitoring with Reliability Techniques in Sterilizer Management
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 285
OP 292
VO 35
IS 6
A1 Hoskins, H. T.
YR 1981
UL http://journal.pda.org/content/35/6/285.abstract
AB The challenge of a sterilization program is to provide a system which will routinely apply accepted process parameters with minimum deviation. Various techniques which avoid the routine use of biological indicators can be used to monitor the system. The accurate physical measurements of cycle time and temperature may be used to calculate “lethalities,” the consistency of which can be monitored with mean and range control charts. In addition, a “safety analysis” on the possible ways that the sterilizer could fault together with recent information on its mechanical reliability will provide a more comprehensive monitoring protocol. The use of the kinetic model for calculating Nabla values is compared to the F0 concept and advantages for the method appear to be more precise definition of the response of microorganisms to heating, together with an ability to follow chemical temperature degradation allowing the use of more accurate chemical markers for the monitoring of heat inputs.