Water is one of the most deciding and vital utilities used by the pharmaceutical and non-pharmaceutical manufacturing industry. As the quality of water used in the manufacturing process will determine the quality of the final product, it may be present as an excipient or used for reconstitution of products, during synthesis, during the production of the finished product Operational efficiency, cost control, time to market and regulatory compliance are prime concerns across the global pharmaceutical industry. As a basic raw material, water and purified media are among the most critical and difficult to manage, components of pharmaceutical manufacturing processes, needing stringent control of parameters like conductivity, microbiology and chemical quality.
To produce Purified Water, it’s necessary to remove organic substances, high and medium molecular weight ions and bacteria/pyrogens to a level that meet the global standards and guidelines.
USP grade purified water generation system
Each plant for the purified water is custom made as per client requirement, Design process majorly depends upon the quality of raw water using in generation.
We provide world class system for PW generation, our systems consistently meet global standards.
- Micron pre-filtration.
- SMBS dosing de-chlorination.
- Twin Softener.
- Multi-stage 316L SS reverse osmosis (RO) feed pump.
- Pharmaceutical full-fit reverse osmosis (RO) membranes.
- Sanitary 316L SS RO vessel.
- ASME BPE compliant 316L SS hygienic product piping beginning at the RO permeate ports.
- Sanitary UV disinfections unit.
- Sanitary 316L SS diaphragm valves & sanitary sample valves.
- PLC based control system.
- Product conductivity monitors.
- Validation documentation.
- Power supply: 60Hz / 460v / 3-PH.
- Polished SS Frame.
- Full recirculation RO/EDI system per cGMP.
High purity water storage & distribution system
High purity water storage and distribution system is custom made as per client requirement, Design process is majorly depend upon the amount of water and number of user points for distribution system.
- Storage & distribution is used to accommodate peak flow requirement against usage rates at the required pressure and temperature.
- SS316L Electro-polished storage tank.
- Centrifugal pump with complete drainability.
- UV Sterilizer.
- Point to use zero dead leg valve.
- Instruments: TOC, Conductivity, Temperature, Flow, Level.
- Sanitary back pressure valve.
- Spray ball.
- 0.2 micron absolute vent filter.
Design Features of High Purity System
- Velocity: 2.5 m/sec in supply line & 1 m/sec minimum in return line.
- Pressure: Positive pressure is require to avoid vacuum during high usage and microbial growth.
- Temperature: To be maintain as per system and users requirement.
- Peak Consumption: Flow rate to be maintain according to diversity factor.
- Dead leg: Less than 1.6D to avoid microbial contamination.
- Drainability: 100% with line slope of 1:100 max.
companies that trust us
Alembic Pharmaceuticals Ltd