The Purified Water required for the manufacturing process is generated by our in-house water purification
1. Municipality Supply Water is used as feed water to produce Purified Water.
2. The purified water system was installed according to ISPE (International Society for Pharmaceutical Engineering) baseline pharmaceutical engineering guide. The purified water meets
3. The Purified Water System is installed as per the following stages:
Primary or Final Treatment
De – Ionizer or Mixed Bed
Micron Cartridge Filter – 5µ
4. An online Stage-1 conductivity is fitted for Reverse Osmosis treated water and De-ionizer treated
water. If the conductivity in the De-ionized water is not more than 1.3µS/cm, purified water
complies with pharmacopoeia specification. Purified water is used for manufacturing process and
final rinsing of manufacturing equipment.
5. A variable frequency drive is connected to high pressure distribution pump, to maintain uniform pressure in all the user points.
6. The water in the distribution loop must be at a continuous flow rate of 1.2m/sec to prevent bio-film build up.
7. The system and distribution loop is sanitized with hot water circulation at 80oC.
8. Dead end valves are used in the pipe lines joints and sampling points to minimize the dead legs.
9. The return loop should have Stage 1 conductivity, if the conductivity is more than the specified value; the water is automatically drained out through Flow Diversion Valve.