Biopharmaceutical, pharmaceutical and other high purity industries utilize systems to produce ultra-high purity and sterile water. These systems are known as WFI (Water for Injection) Systems or WFI Distribution Loop system. Typical uses for these systems can be found in Sterile Bulk API (Active Pharmaceutical Ingredient), BPC (Bulk Pharmaceutical Chemical) preparation, Parenteral Dosage Forms, and final cleaning for the applications listed previously.
WFI systems typically involve several subsystems or additional systems for the water production, storage and distribution. Facilities may utilize a pre-treatment system that includes Pressure/Carbon Filters, Reverse Osmosis System, Ultra Filtration and a UV sterilizer. The next subsystem typically involves the production of WFI by distillation (Vapor Compression or Multi-Effect), Reverse Osmosis, or Ultra-Filtration.
Additional subsystems include the WFI storage system, which maintains the WFI at temperature, and the WFI Distribution Loop, which includes pumps and back pressure valves.
In these WFI Systems several parameters are measured to control certain negative outcomes:
- Nitrates: Negative Health Impacts
- Conductivity: Ionic Contaminants
- Heavy Metals: Toxic to humans and animals
- TOC: Food for microbes
WFI Distribution Loop Systems, like other Biopharmaceutical systems, have design recommendations to maintain physical, chemical and microbiological properties of the WFI; maximize system capacity; and avoid design issues that cause dead legs, incomplete sanitation and poor treatment. Designers use some of the following principles to help minimize issues and maximize output: sanitary diaphragm valves, sloping lines for draining, SIP/CIP compatible components and proper heating.
The Equilibar ® FD Series Back Pressure regulator offers precision pressure control across a wide range of flow rates and conditions. The FD Series is designed with the following features to help meet Biopharmaceutical WFI Distribution Loop design principles:
- Drainability: Drainable and minimal hold up with air blow
- CIP/SIP: Materials of construction capable of meeting cleaning requirements at elevated temperatures
- Sanitary/Hygienic Design: Mechanical and electropolished surfaces with tri-clamp connections
- USP Class VI diaphragms
- Ultra wide flow windows
- High precision
Contact an application engineer today to discuss your application requirements.