All criticalities emerged during the FAT exercise are then checked again at the final site, after installation and verification; additional test cases may also be added to the Site Acceptance Test (SAT) protocol to check for potential failure modes. SAT testing is performed once all connections between the new equipment and other machines/software’s are in place, under the real operating parameters, and may be witnessed by a representative of the equipment’s manufacturer.
Results from Site Acceptance Test (SAT) may thus differ from those obtained from the FAT previously run by the manufacturer. From the regulatory point of view, SAT testing is a key element to demonstrate the compliance of the equipment to GMP requirements and to support the overall quality and safety of pharmaceutical productions. In this case too, many are the possible elements to be inspected and verified, including interlocks, ventilation, internal box pressure, electrical/hydraulic connections and safety systems, visual checks of components, training of the operators, etc.
- Site Acceptance Test for FBD
- Site Acceptance Test for CO-Mill
- Site Acceptance Test for L & T Device
- Site Acceptance Test for FBD (Non-Rifa)
- Site Acceptance Test for RMG
- Site Acceptance Test for Tipper (120 kg)
- Site Acceptance Test for Lifting & Positioning Device
- Site Acceptance Test for Gancoater
- Site Acceptance Test for Pillar Blender
