Is the validation process the same for sterile presaturated vs. sterile dry wipers?
Yes, the validation process is the same for presaturated vs. dry as they both follow ANSI/AAMI/ISO 11137, Sterilization of Health Care Products.
The product is saturated, packaging is sealed and then the cases are sent to be irradiated. The cases are irradiated wet.
Click here to read “Sterile Cleanroom Consumables Management” written by Lynn Standard, Senior Quality Manager for Berkshire.
If you need more information about the definition of Validated Sterile and the required documentation, read our Technical Brief, “When It Has to Be Sterile”
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