PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
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Validation of Radiation Sterilization
Hiroshi TSUKAMOTO
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2001 Volume 3 Issue 1 Pages 13-19

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Abstract

  When Toray company began gamma-ray sterilization of dializer in middle of 1970's, sterilization dose to realize 10−6 of SAL is set by D-value of B. pumilus's spore suspension and bioburden level. After then AAMI's B1 method was selected in accordance with the requirement of FDA. Currently ISO11137's method2, which is harmonized with AAMI's method 2, is selected in accordance with Japanese guideline of sterilization validation and related requirement. Parametric release is implemented for product release.

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© 2001 Parenteral Drug Association Japan Chapter
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