2001 Volume 3 Issue 1 Pages 13-19
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.