Determining whether a product is steam sterilizable
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Updated: Oct 21, 2026

The Portable Chemical Sterilizer (PCS), D-FENS, and D-FEND ALL: Novel Chlorine Dioxide Decontamination Technologies for the Military
Published on: June 29, 2014
1Fujisawa USA, Incorporated, Deerfield, Illinois, USA.
Abstract:
The FDA has issued proposed regulations to require that manufacturer's evaluate the "steam sterilizability" of parenteral products. There are many different ways to assess sterilizability. Within a company, it is helpful to standardize the methodology used to determine whether the product should be terminally sterilized. The following is one approach to determining product sterilizability. This approach is also depicted in a flow chart (Figure 4).
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