Water is the most critical ingredient in any pharmaceutical & life sciences operations and when used for production at any volume, is highly regulated. All pharmaceutical waters are subject to Food and Drug Administration (FDA) and current Good Manufacturing Practice (cGMP) guidelines for the removal of minerals, organics, and microbes even when water does not remain in the finished product.
Within the pharmaceutical industry, water is most commonly used in liquid form, not only as an ingredient in many formulations but also as a cleaning agent. Production of Purified Water, pyrogen-free Water, Water for Injection (WFI) and Clean Steam to international pharmaceutical standards is widely recognised as a critical process.
Valfit Engineers offers wide range of Purified water generation, Storage and Distribution system along with Pure Steam Generation, WFI Generation, Storage and Distribution system.
System Controlling & Automation
• Electric Control Panel
• PLC with HMI
• Comply with 21 CFR Part 11
1.Pre-treatment Plant
a) Multi Grade Filter
b)Softener
c) Ultra Filtration System
d) Reverse Osmosis System (CSRO)
2.Purified Water Generation System
a) Mix Bed Plant
b) Reverse Osmosis System (HSRO)
c) Electro Deionization Unit
3.Purified/ WFI Storage & Distribution
a) Storage tank volume calculation as per Generation capacity & user point consumption.
a) Storage tank volume calculation as per Generation capacity & user point consumption.s
c)Piping slope will be maintained in the ratio of more than 1:100 towards drainable point to maintain full drainability.
d) Dead Leg less than 2.5D in Loop System.
e) Sanitary Tri-clover End Connections along with Electropolished Tubes with finish less than 0.5 Ra.
f) Orbital Welding Joints along with Borescope of Joint as per requirement.
g) Hot Water Sanitization/ SIP provision for Tank & Piping loop.
h)Auto/ Manual Changeover of Pump as per requirement
4.Multicolumn Distillation Plant
5.Pure Steam Generation & Distribution
