I am specifiying a production process for a Class II device intended to be used adjacent to a sterile field that cannot sustain any conventional process for terminal sterilization without adversely affecting its performance. If the components of the device are packaged, sterilized, then assembled within an aseptic process and repackaged, could this suffice?
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Shepard Bentley RAC
President and Principal Consultant
Laguna Niguel CA
United States
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