Storage & Distribution System is required to store and distribute the PW / WFI within the plant. The system ensures stringent quality parameters of Pharmaceutical / Biotech industry. The distribution system is a closed loop system. Closed loop system ensures integrity of the PW & WFI. The entire Storage & Distribution System parameters are monitored & controlled with the help of instruments & equipments mounted on Distribution Skid.
APPLICATIONS
PW / WFI Storage & Distribution System is required for
• Purified Water / WFI Storage
• Distribution of Purified Water / WFI
• For Sanitization of PW Tank & Distribution Loop
• Controlling Microbial Load in WFI / PW
• Rejecting High Conductivity PW / WFI
• Sterilization Process Management
WFI Tank & Distribution Loop
FEATURES
• PW and WFI Storage Tanks are manufactured as per cGMP guidelines and ASME VIII, DIV 1 standard
• Storage tanks can be plain, jacketed or limpet type. Jacketed and limpet tanks are provided suitable rockwool / glasswool insulation and AISI 304 stainless steel cladding
• If required, provision of electric heating can also be provided with suitable insulation & cladding
Process nozzles will be flushed sanitary flange type
• To make sure optimum cleanability, all tanks are Riboflavin tested
• PW / WFI tanks are provided with necessary accessories for reliable operation
• IPC & PLC based fully automated plant complies with 21 CFR Part 11 & GAMP 5
• Fully drainable sanitary pumps are selected to maintain minimum velocity of 1.2 m/s in the return line at peak load consumption
• Two pumps (Duty / Stand by) are provided to ensure continuous hassle-free operation along with swing arm assembly for changeover
• Distribution skid is provided with instruments to monitor parameters like temperature, conductivity, pressure, flow rate, velocity and also TOC count
• Distribution piping is designed for minimum dead leg criterion of < 1.5 D
• Distribution Loop tubes are semi seamless tubes as per ASTM A270
• All contact parts MOC is AISI 316L Stainless Steel and electro polished to less than 0.4 Rasurface finish and Non-Contact parts are AISI 304 Stainless Steel
• The Distribution loop is designed for 100% drainability by maintaining the minimum slope of 1:100
• All weld joints in the loop are orbital welded using high purity (99.99%) argon gas and can be inspected by boroscopy machine
• Complete set of documentation and certificates to ensure compliance with regulatory authority. We provide DQ, OQ, IQ, FAT & SAT. Also assist client to develop PQ
