Once the water reaches Purified Water Quality or WFI quality, stagnation is not desired and therefore a Pharmaceutical Water System is always kept in recirculation 24 x 7 x 365 days.

In purified water and WFI applications, the water is kept in recirculation in entire loop 24 x 7. Following are the features of Praj Hipurity Systems Limited designed recirculation systems

• Skid Mounted, modular in design
• Consists of a recirculation pump
• Standby pump: Recirculation pump with a standby arrangement
• Duty condition: 24 x 7
• Inlet & Outlet Piping: SS316L electro polished tube
• Instruments: Conductivity Sensors, Flow Transmitters, Pressure Gauges
• Valves: Diaphragm Valves
• Sanitization: Hot Water Sanitization at 85°C or Pure Steam Sanitization at 121 °C

Praj Hipurity Systems Limited is using SS316L Electropolished tubes for distribution piping – tubes and fittings for all sanitary piping which includes distribution piping. Praj Hipurity Systems Limited can offer various surface finishes deploying in house Electro-polishing facility. Generally for PW and WFI surface finish mechanically polished followed by electropolishing.

Size Selection – distribution piping is sized based on the following inputs from our customerss

• Peak Load (Consumption) of PW or WFI
• Duration and variability of consumption throughout the day
• Total Consumption
• Minimum return line velocity to be maintained in the return line

Pharmacopoeia around the globe is laying importance and reliance on ‘Process Analytical Technology’. At one point in time Pharma companies used to release PW or WFI based on daily sampling analysed offline in the laboratory. Fast forward to today, excluding microbial analysis rest all the parameters are monitored online thereby enabling on the spot decision on releasing water for production activities or disallowing the same based on parametric deviation observed

Praj Hipurity Systems Limited is aligned with global instrumentation OEMs to provide best in class analytical instrumentation and controlled integrated with PLC based or DCS based control systems.

PLC Based Control Systems: Majority of the industrial systems are PLC based operated using Human Machine Interface (HMI). These are robust systems which can be integrated with any Data Acquisition technologies available.

21 CFR Part 11 & GAMP5 Compliance: Pharmacopoeia is laying emphasis on increased safety for consumers and thereby reflecting into stringent data integrity, audit trail and validation requirements specified in 21 CFR Part 11 Compliance of US Pharmacopoeia or equivalent specifications globally. PHS systems are compliant with 21 CFR and GAMP5 requirements to enable our customers to comply with regulatory requirements enabling smoother qualification and audit compliances.

Distributed Control Systems (DCS): Praj Hipurity Systems Limited has experience in integrating the water systems with DCS controllers. For a large number of systems involved DCS controlled systems becomes a very advanced solution. This has distinguished advantages over PLC based systems as below –

PHS Advantage

• Being turnkey designer & manufacturer of process solutions as well as water solution, PHS can envision plant level integration requirement and suggest a solution
• Praj Hipurity Systems Limited has experience with world-class DCS automation vendor partners on some of the marquee projects

Sanitization/Disinfection/Sterilization

• Sanitization 3 log reduction
• Disinfection 3+ log – 5+ log reduction
• Sterilization 6 log reduction

Heat

• One of the most reliable methods of sanitization/disinfection of water systems above 65˚ C
• Hot Water Sanitization: 85°C
• Pure Steam Sterilization : 121°C
• Superheated Loop Sterilization: 121°C

Ozone – Electrolytic (Water-Based)

• Produced easily
• Leaves no residue
• Materials compatibility

Loop Sanitization

Single Generation- Single Tank Configuration

• Most prevalent configuration – single production facility is fed by dedicated loop which is filled by common generation system

Single Generation- Multiple tank design

• Most common configuration when multiple production areas are to be fed using same generation system.
• Priority filling of the tanks can be programmed to ensure high priority area loop gets water whenever required without starving

Common Tank with feeding two loops

• Suitable when space constraint is there and multiple tanks cannot be housed in the same area
• When system undergoes sanitization both loops need to be sanitized together and both production areas need to be stopped

Mother Loop Child Loop

• Single mother loop can feed to single or multiple child loops
• Individual loop can be sanitized independently
• Suitable when single facility houses multiple product lines/suits/production blocks

Hot Distribution Loop

• Hot loop eliminates possibility of microbial /biofilm buildup however involves high operating cost due to continuous heating requirement. At each point of use the water may also have to be cooled before consumption

The sterile manufacturing process in Pharmaceutical and Biopharma applications require pure steam for sterilization of equipment or for products (Terminal Sterilizers). Thus pure steam distribution becomes an essential part of clean utilities. It involves –