The main features of the system are:
– Storage tank with all pasts in contact with WFI made of stainless steel AISI-316L and the rest in stainless steel AISI-304. Designed by CIFA to reduce susceptible áreas to contamination, spray ball in the WFI return. Venting filter heated of 0,22µm.
– A pharmaceutical feeding pump, to continuously recirculation of WFI. Its power is monitored by a variable-frequency motor drive that receives a signal from a non-invasive flowmeter in the storage tank return pipe. The flow set point is 1,4 m3/h to maintain a minimum return velocity in the return line of 1 m/s, according FDA recommendation for this kind of facilities.
– Distribution loop made of pharmaceutical pipe, according to ASME BPE standard, with polish SFT1. All the welds are made by an orbital automatic TIC procedure.
– Temperature control system by a heating half-round in the storage tank. This system allows to maintain a stable temperature of 80ºC in normal working conditions and allows increase the temperature to 121ºC to do a thermal sterilization.
– User point valves “zero dead leg” type ensure a complete draining and minimize the microbial contamination risk.
– The control system is based on a Siemens PLC with ET200 architecture and a touch screen of 10” manage the system, select and monitor the parameters. This system only Works under operator password with identification function limits.
Non-proprietary parts (Gemü, Siemens, Festo, SMC)