RT Journal Article
SR Electronic
T1 Evaluation of High-Temperature and Short-Time Sterilization of Injection Ampules by Microwave Heating
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 5
OP 12
VO 52
IS 1
A1 Koichi Sasaki
A1 Washiro Honda
A1 Yasuo Miyake
YR 1998
UL http://journal.pda.org/content/52/1/5.abstract
AB The high-temperature and short-time sterilization by microwave heating with a continuous microwave sterilizer (MWS) was evaluated. The evaluation were performed with respect to: [1] lethal effect against microorganisms corresponding to F-value, and [2] reliability of MWS sterilization process. Bacillus stearothermophilus ATCC 7953 spores were used as the biological indicator and the heat-resistance of spores was evaluated with conventional heating method (121–129°C). In MWS sterilization (125–135°C), the actual lethal effect against B. stearothermophilus spores was almost in agreement with the F-value and the survival curve against the F-value was quite consistent with that for the autoclave. These results suggest that the actual lethal effect could be estimated by the F-value with heat-resistance parameters of spores from lower than actual temperatures and that there was no nonthermal effect of the microwave on B. stearothermophilus spores. The reliability of sterilization with the MWS was confirmed using more than 25,000 test ampules containing biological indicators. All biological indicators were killed, thus the present study shows that the MWS was completely reliable for all ampules.