New FDA Information on SYSTEM 1E Liquid Chemical Sterilant Processing
The Food and Drug Administration has changed some statements in its Device Approvals and Clearances section for the SYSTEM 1E Liquid Chemical Sterilant Processing System manufactured by STERIS Corporation.
The revised language reads as follows: "The rinse water is tap (potable) water that has been filtered and exposed to ultraviolet rays. It is treated to minimize bioburden that may be naturally occurring in the water. The treatment method eliminates bacteria/fungi/protozoa from the water. Studies with the test virus MS2 (EPA recommended surrogate for waterborne viruses) showed a 6 log reduction."
To access the FDA document, CLICK HERE.
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