PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
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READY-TO-FILL® STERILE COMPONENTS KIT: STERILITY ASSURANCE AND ITS FUTURE PROSPECT
Thomas ThorpeHiroshi TAMAZAWA
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JOURNAL FREE ACCESS

2014 Volume 16 Issue 2 Pages 29-37

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Abstract

  Purchasing, validating, maintaining and operating container/closure cleaning and sterilization/depyrogenation equipment for periodic use in aseptic filling demands human, financial, and floor space resources an organization can better allocate elsewhere in small-scale drug development. In this paper, the authors describe how the innovative pre-packaged Ready-to-Fill® sterile components are cGMP-prepared suitable for aseptic filling and indicate the various benefits to pharmaceutical companies and medical institutions of all sizes.

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© 2014 Parenteral Drug Association Japan Chapter
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