Spirax Sarco manufacture its range of pure steam generators, multiple effect stills, purified water systems and storage and distribution systems within ISO 9001 certified facilities, and as such operate state-of-the-art material and manufacturing process tracability systems. Documentation packages are produced as a matter of course, to demonstrate and record that we have adhered to a cohesive quality control process in accordance with good engineering practice.

Turn-Over Packages (Operation and Maintenance Manual)

Every pure steam generator, multiple effect still, purified water system and storage and distribution system produced is supplied as standard with a comprehensive Operation and maintenance manual including the following documents:

  • Instrumentation list
  • Operation and Maintenance Instructions
  • Functional Specification
  • Detailed Design Specification
  • Factory Acceptance Test
  • Vendor literature
  • Test data including endotoxin test if required
  • Pasivation and elecropolishing certification
  • ASME / European weld documentation

Factory Acceptance Testing

On completion of manufacture, all high purity generation equipment put through a Factory Acceptance Test (FAT). This testing thoroughly checks all alarms and interlocks as well as functional testing of equipment to demonstrate performance and capacity. Any other specific requirements as outlined in the functional specification are also tested at this time.

At this time 'pre-qualification' of the equipment, carrying out the same test procedures as outlined in the Installation Qualification (IQ) and Operational Qualification (OQ) protocols can be performed to ensure any minor issues are resolved prior to Site Acceptance Testing (SAT) and IQ / OQ execution.

Validation

Spirax Sarco is well qualified to provide the required documentation, develop the required protocols and execute these protocols to achieve validation compliance. The completed Installation Qualification (IQ) and Operational Qualification (OQ) document that the equipment provided fully meets the criteria as outlined in the User Requirement Specification (URS), Functional Specification (FS) and Detailed Design Specification (DDS), as well as complying to the latest FDA and cGMP requirements.