PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Articles
A Simple Method to Control Bowie-Dick Test Cycle Correctly in the Prevacuum Autoclave without the Automatic Bowie-Dick Test Mode
Yushi UETERAHiroshi SHIGEMATSUZenzou BABANaohito KUMADAShinsuke OOHARAChizuru KOMORIYuhei SAITOYoshikazu MIMURAToshihiko OOBAYASHI
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2005 Volume 7 Issue 1 Pages 55-58

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Abstract

Health Technical Memorandum 2010 (HTM 2010) defines the sterilization phase of Bowie-Dick test cycle as 134.0-137.0°C for 3 min 18 sec to 3 min 30 sec. However, the three prevacuum autoclaves installed in our surgical center were not equipped with the automatic Bowie-Dick test mode. Moreover, holding time can be programmed only at a minute interval. Consequently, the authors devised a simple method to control Bowie-Dick test cycle correctly in these prevacuum autoclaves. In the present study, the measurements were performed twice in each prevacuum autoclave to evaluate the usefulness of this method. The sterilization temperature was programmed at 134.0°C. Process skip button was operated manually when the actual sterilization temperature was maintained over 134.0°C, for 3 min 10 sec in autoclave No. 1, 3 min 5 sec in autoclave No. 2, and 3 min 15 sec in autoclave No. 3, respectively. The actual holding time was measured using a stopwatch. The actual sterilization temperature was also monitored on the control panel of the sterilizer. The maximum sterilization temperature was investigated in each sterilizer. It was also investigated how long it took for the actual sterilization temperature to decrease to 134.0°C after process skip button was operated. In all measurements, the actual holding time and actual sterilization temperature satisfied the recommendations of HTM 2010. It took 16-17 sec in autoclave No. 1, 21-22 sec in autoclave No. 2, and 11-13 sec in autoclave No. 3, respectively, for the actual sterilization temperature to decrease to 134.0°C after process skip button was operated. The present study suggested that our method is useful to perform Bowie-Dick test correctly in our prevacuum autoclaves. It was also suggested that it is important in our method to determine when process skip button should be operated in each prevacuum autoclave.

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© 2005 Parenteral Drug Association Japan Chapter
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