BioPharma® Sterilizers - Installation Qualification/Operational Qualification (IQ/OQ)
PRIMUS offers Installation Qualification and Operational Qualification documents for clients required to validate their PRIMUS Sterilizers. PRIMUS provides a customized IQ/OQ package for each client to be executed on-site by a qualified Validation Technician. Contact PRIMUS for pricing and availability.
IQ – verifies the physical characteristics, including the mechanical and electrical components of the equipment, to the manufacturer’s specification.
OQ – verifies the operation of the equipment. All inputs and outputs; alarms, abort conditions and process operation are challenged. A final report containing a Certificate of Completion, IQ/OQ Protocol, Piping and Electrical Schematics and Spare Parts list is issued to the customer at the completion of this service.
A typical IQ/OQ can be completed within three (3) to four (4) days. Contact PRIMUS three (3) weeks prior to the requested IQ/OQ to allow scheduling of personnel.
The documents below are a sample of an IQ/OQ Table of Contents for PSS5, PSS6, PSS7 and PSS8 control platforms.
F2045. PSS6 Primatic IQ OQ SW 3.300-1.00-SAMPLE TOC
F2052.PSS500 IQ OQ 2.00 SAMPLE TOC
F2116. IQ OQ PSS7 Primatic SW CtrlLgx 1_300-1_00 SAMPLE TOC
F2116. IQ OQ PSS8 Trinity SW 2_550 V1_00 SAMPLE TOC