The manufacturer of process equipment must control the critical aspects of the operations they implement through a qualification and validation programme throughout the product and process lifecycle. Any planned change to facilities, equipment, utilities and processes that may affect product quality must be formally documented, and the impact on validation status or the control strategy must be assessed.

To this end, STERIGENE has developed a team of validation managers and technicians specialising in the development of protocols in accordance with applicable standards, and in qualification interventions for the process equipment on your production lines.