Tenders Are Invited For Industrial Machinery – 1 System Production, Storage And Distribution Of Aqua Purificata(Ap) And Water For Injection(Wfi)

Industrial Machinery – 1 System Production, Storage And Distribution Of Aqua Purificata(Ap) And Water For Injection(Wfi). The Contractor Supplies A Multi-Stage Ultrapure Water Generator For The Production Of Water For Injection (Wfi). The Existing Wfi And Ap Systems For Water Storage/Distribution Will Be Retrofitted. The Contractor Creates New Automation Across The Entire System And Integrates The Existing Clean Steam Generator. The Applicable Regulations For Use In The Pharmaceutical Gmp Area As Well As The Guidelines According To Gamp 5 With Regard To The Automation System Must Be Met. The Order Includes (For Details See Specifications Vvo / 111733 / 000 / 00): · Project Management And Project Planning · Engineering, Construction, Automation And Production · Change Service · Design Qualification · Risk Analysis (Traceability Matrix) · Factory Acceptance Test Fat (Factory Acceptance Test) · Packaging, Customs Clearance, Transport · Responsible For The Dismantling / Disposal Of The Existing Systems · Introduction, Assembly, Installation · Commissioning · Sat (Site Acceptance Test) · Installation Qualification · Functional Qualification · Calibration · Technical Release Of The System · Documentation/Training