Thermo Scientific™ (IOPQ) Qualification and Performance Service

Descripción

• IQ: Verifies that the installation site and equipment environment meet manufacturer-specified environmental requirements.
• Verifies that the equipment, manuals, supplies and any other accessories arrived undamaged as specified in the sales order.
• Verifies equipment and any other accessories are assembled and installed.
• Configuration information for each system component gets recorded. Installation of Equipment is NOT Included.
• OQ: Verifies important equipment functions and ensures that the equipment operates as expected by the manufacturer and in conformance to standards and requirements.
• Key test: Door Ajar, Power Failure, Temperature Alerts PT: Temperature Mapping protocol performed at customer specified set point with provisions up to 15 measurement points, plus 1 ambient measurement point.
• Temperature measurements will be performed in air or with simulated product loaded in chamber with a data collection interval of 1 minute for up to 24 hours, or configurable to customer needs.
• Study requirements greater than 24 hours will be reviewed and quoted.
• Temp Mapping service will include: (a) 1 open door temperature recovery test (b)1 power failure test (c) Min and max values along with averages (d) Temperature graph over a time period (e) Detailed reports will include raw probe data. All of this will be performed and delivered by a Thermo Fisher Qualified Engineer equipped with training certificates,temperature mapping data logger calibrated annually with metrology certificates.