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Turnkey Solutions

Validation and documentation engineers monitor every order through all stages of the V-model, from the URS (user requirement specification) right up to acceptance by the client (FAT/SAT), IQ and OQ. BWT Pharma & Biotech also provides support during the PQ phase.

 

BWT Pharma & Biotech’s services and components for turnkey systems:

  • Concept design, basic design, consultancy services, case studies

  • Support via technical specifications (URS)

  • Detail design

  • Generation of pure and ultrapure water, water for injection and pure steam

  • Storage and distribution systems

  • Fully sterile production facilities, including shim lines, CIP/SIP and waste water deactivation

  • Ozone and hot water sanitisation for distribution systems

  • PLC systems and SCADA (supervisory control and data acquisition) compliant with 21 CFR Part 11, GAMP

  • Design, maintenance and consultancy services

  • Certification, validation and full documentation, compliant with cGMP