Process equipment qualification

Qualification documentation should provide the evidence that equipment is working properly and meets expected results. We conduct qualification of process equipment in accordance with the validation master plan.

Typically qualification consists of the following stages:

  • Design qualification (DQ) is a documented verification that the proposed design of the process equipment is suitable for the intended purpose.
  • Installation qualification (IQ) is a documented verification that the process equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations.
  • Operational qualification (OQ) is a documented verification that the process equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.
  • Performance qualification (PQ) is a documented verification that process equipment can perform effectively and reproducibly based on the approved process method and product specification.

We perform the qualification of:

  • laminars
  • air-locks
  • isolators
  • washing, depyrogenization, filling and capping machines
  • freeze-drying machines
  • inspection machines
  • steam sterilizers
  • hot-water sterilizers
  • dry heat sterilizers
  • balances
  • fluid bed dryers
  • reactors, tanks, mixers
  • capsule filling machines
  • tablet presses
  • film coating machines
  • sachet packaging machines
  • suppository filling machines
  • labeling machines
  • packing machines