PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Volume 7 , Issue 1
Showing 1-10 articles out of 10 articles from the selected issue
Preface
Special Section
Topics Review
Articles
  • Yushi UETERA, Hiroshi SHIGEMATSU, Zenzou BABA, Naohito KUMADA, Shinsuk ...
    2005 Volume 7 Issue 1 Pages 55-58
    Published: 2005
    Released: July 07, 2006
    JOURNALS FREE ACCESS
    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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  • Hiromi NOMURA, Masahiro ODA, Takao HASEGAWA
    Type: Others
    Subject area: Others
    2005 Volume 7 Issue 1 Pages 59-67
    Published: 2005
    Released: July 07, 2006
    JOURNALS FREE ACCESS
    Mustang® is composed of microporous modified hydrophilic polyethersulfone (PES) membranes, having uniform coating with quaternary amine (Q) group and sulfonic acid (S) group. Mustang® membrane chromatography shows high binding capacity even under the high flow rate, by its larger pore size, and convective surface structure. Therefore, Mustang® purification technology has merit as a simple, speedy, and scalable one, especially for removing of harmful factors and impurities in bioprocess purification, and also the purification of macromolecules like DNA, virus, plasmid, and proteins etc. Here it is introduced the examples of the viral/DNA removal, and adenovirus vector purification using Mustang® membrane chromatography. Safety and quality assurance can be added into manufacturing process of biological drugs by applying and strengthen this separation and purification technology.
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