In the beginning of a project a Quality & Project Plan is set up to show the Quality Control in the project, together with scope, responsibilities, communication routes, submittals etc. This document is given to the customer for approval.
The water treatment systems are validated according to FDA, cGMP, GAMP, USP and Ph. Eur. requirements. BWT Pharma & Biotech also follows the ISPE Engineering Baselines for Water and Steam Systems, and Commissioning and Qualification. The systems are CE-marked.
Skid-mounted systems leave the factory after a successfully executed FAT in order to shorten commissioning and validation on site. The FAT is carried out together with the customer under real conditions. For turnkey projects, the required equipment skids are installed as a complete system. Commissioning and qualification are then performed before the final handover to the customer.