The common requirements outlined in the “General” section below are required. Additionally, product contact surfaces must be stainless steel or approved plastics or rubber.
EQUIPMENT INSTALLATION QUALIFICATION
The Installation Qualification will confirm details from the engineering specifications, equipment purchase order and cGMP guidelines and requirements, as well as verifying that the equipment has been installed as specified by the vendor of the equipment. Under normal circumstances the equipment is totally installed; installation punchlists are complete; start-up activities are completed and any deficiencies have been corrected. The pre-approved IQ protocol will list the equipment requirements, and the vendor installation requirements. The IQ will document the existence and location of equipment documentation.
During each IQ, equipment design, construction and materials of construction will be verified against engineering specifications, purchase requirements and GMP issues. The piece of equipment will be examined to confirm proper connection and installation of the supporting services and components relative to vendor specifications. The location of all appropriate support documentation (such as manufacturer’s manuals, purchase orders, test results, spare parts lists, certificates) will be referenced. Manufacturer’s tag data will be collected. MAKE, MODEL AND DESIGN:
The identification number, model number, and serial number is recorded. Confirm that the equipment delivered and installed conforms to specifications. Materials of Construction: Vendor certification of materials of construction must conform to specifications. Valve Types and Connections: The valve types must conform to specifications. All connections in the equipment and from the equipment to utilities must conform to specifications. PRESSURE VESSELS:
ASME tag information and manufacturer’s tag information is verified. Vessel capabilities must conform to specifications ELECTRIC MOTORS AND PUMPS:
Manufacturer’s tag information (voltage, amps, phase, frequency, and horsepower) and control information (fixed or variable speed, direction of rotation and RPM). Capacities must conform to specifications. INSTRUMENTATION:
The instruments on the equipment are identified, the ranges verified, and the manufacturer’s information recorded. The locations and ranges of the instruments. . UTILITIES:
A general listing of the electrical and utility services supplied to the equipment is supplied and information on the pressure, source, voltage and phases is recorded. Installation conforms to vendor requirements. Drains must be supplied with an air break. FILTERS:
All filters are properly installed and the documentation of integrity testing is available. DOCUMENTATION:
The location of other appropriate support documentation (such as manufacturer’s manuals, purchase orders, test results, spare parts lists, certificates, passivation, leak testing) will be verified.