The Purified Water / Water for Injection (WFI) Storage & Distribution System series by Flocon Industries is a GMP-compliant solution designed for hygienic storage, continuous circulation, and safe distribution of purified water or WFI, with high operational efficiency. We analyse your requirements to provide you with a cost-effective system engineered with SS316L Stainless Steel construction, automated monitoring systems, and a fully drainable sanitary design that eliminates contaminants and provides your operations with purified water output.
Our systems are designed in accordance with regulatory compliance to meet key governing standards for purification through strict limits on conductivity, TOC, endotoxin, and bioburden. Our closed loop recirculation process maintains a return velocity of NLT 1.2 m/s, which prevents biofilm formation and maintains temperature-based bioburden control for hot loops. This ensures your operations receive consistent pure water quality with total microbial growth control. We understand the value of finite resources; this thought process is reflected in our system design, optimised in accordance with ESG norms for low wastewater ratios and longer life cycles without compromise on quality. Thus, you get a purified water solution that supports reliable, uninterrupted process operations with optimised efficiency and validation-ready performance. Our systems incorporate Integrated automation, online instrumentation, and intelligent control systems enabling real-time monitoring. Additionally, data logging, alarm management, and complete traceability ensure compliance with cGMP, US FDA, WHO, and global pharmacopoeial requirements, including USP, EP, and IP standards.
Our systems are designed and optimised with features that safeguard your product quality, medical safety, and process integrity, making our systems ideal for pharmaceutical, Injectables, biotech, and healthcare industry applications.
Designed and manufactured in accordance with cGMP and ASME BPE hygienic design principles.
Chemical dosing system with controlled detergent concentration.
Fully automated operation with PLC-based control and HMI touchscreen interface.
Multi-tank configuration available for detergent, purified water, WFI, and recovery systems.
Recipe-driven cleaning and sterilization cycles with configurable process parameters.
Steam sterilization with automatic temperature control and validated holding periods.
Automatic control of temperature, flow rate, pressure, conductivity, and cycle time.
Integrated instrumentation including temperature transmitters, pressure gauges/transmitters, flow meters, conductivity sensors, and level sensors.
Integrated CIP and SIP functionality for cleaning and steam sterilization of process equipment and piping.
Data logging, batch reporting, alarm history, and audit trail capabilities (optional 21 CFR Part 11 compliance).
Constructed using SS 316L for all product-contact parts with hygienic surface finish.
Compact skid-mounted construction for ease of installation and maintenance.
Sanitary piping with orbital welding and hygienic fittings to eliminate dead legs.
Validation documentation support including DQ, IQ, OQ, FAT, SAT, and material certificates (as required).
Designed for compatibility with pharmaceutical process vessels, reactors, mixers, storage tanks, transfer lines, and filling systems.
| Purified Water (PW) / Water for Injection (WFI) Storage & Distribution System | ||
|---|---|---|
| Parameters | Purified Water (PW) | Water for Injection (WFI) |
| pH | 5 – 7 | 5 – 7 |
| Conductivity | < 1.3 µS/cm @ 25°C | < 1.3 µS/cm @ 25°C |
| Total Organic Carbon | < 500 ppb | < 500 ppb |
| Pathogens | Absent | Absent |
| Total Microbial Count | < 100 CFU/ml | < 100 CFU/100ml |
| Endotoxin | NA (< 0.25 EU/ml for Endotoxin-free PW) | < 0.25 EU/ml |
| Capacities (Customizable) | As per Requirement | As per Requirement |
| Purified Water (PW) / Water for Injection (WFI) Storage & Distribution System | ||
|---|---|---|
| Parameters | Purified Water (PW) | Water for Injection (WFI) |
| pH | 5 – 7 | 5 – 7 |
| Conductivity | < 1.3 µS/cm @ 25°C | < 1.3 µS/cm @ 25°C |
| Total Organic Carbon | < 500 ppb | < 500 ppb |
| Pathogens | Absent | Absent |
| Total Microbial Count | < 100 CFU/ml | < 100 CFU/100ml |
| Endotoxin | NA (< 0.25 EU/ml for Endotoxin-free PW) | < 0.25 EU/ml |
| Capacities (Customizable) | As per Requirement | As per Requirement |
Uses Multi-Effect Distillation Plant or Vapor Compression process to evaporate and condense purified water, ensuring absolute sterility and removal of pyrogens/endotoxins for parenteral manufacturing.
Stores the purified water in sanitary, monitored vessels designed to maintain purity and prevent recontamination.
Continuously circulates purified water through a hygienically controlled closed-loop pipe network to supply to point-of-use.
Periodic flush with controlled thermal water, pure steam or compatible cleaning agents to destroy microbial contaminants and eliminate biofilm formation.
Purifies feed water through pre-treatment, reverse osmosis and continuous electrodeionization to eliminate bio-impurities, minerals, and ions to produce high-purity water.
Stores the purified water in sanitary, monitored vessels designed to maintain purity and prevent recontamination.
Continuously circulates purified water through a hygienically controlled closed-loop pipe network to supply to point-of-use.
Periodic flush with controlled thermal water, pure steam or compatible cleaning agents to destroy microbial contaminants and eliminate biofilm formation.
Years of advisory, purification expertise and client trust for storage and distribution systems
Positive passing rate of US FDA, WHO, and EU GMP ( Annex 1) compiance audits
Complete DQ/IQ/OQ validation package along with supporting documentation followed by protocol execution support.
Designed to meet current USP/BP/EU pharmacopoeia standards and WHO / cGMP requirements.
Find answers to common questions about our industrial and manufacturing services, processes, and support. If you need more details, our team is always ready to help.
Our experts are here to guide you through every step of your industrial transformation journey.
In an ideal situation, at the start of the shift, an Operator should be checking on all the activated alarms and alarm history to check for any deviations in the working of the purified water / WFI storage and distribution.
A sudden spike in online conductivity generally indicates cross contamination in a PW/WFI Storage and distribution system. These contamination are mostly likely to occur from user points. In normal circumstances a minor spike in conductivity is taken care by the return line conductivity sensor, which shall divert the water towards drain. But for bigger contamination issues where the conductivity levels do not come below limits, its advised to drain complete water from tank and total piping, perform a hot water sanitization cycle and then restart system.
To safely switch from one recirculation pump to the standby pump, it should be aware that the PW/WFI storage and distribution system can be exposed to atmospheric contamination, handling of equipment and unused equipment (Standby pump). Hence this activity should always be planned along with the Hot water Sanitization activity SOP after connecting the Standby pump to ensure that the system is not affected by any microbial and chemical contamination.
A Company should prepare an SOP for diaphragm valve inspection and seat replacement at a suitable interval. Generally visual inspection is sufficient and should be performed once in 3-6 months to ensure that the Purified water / Water for injection Storage and distribution system quality is not compromised. Additionally as Diaphragms are subjected to wear and tear, they should replace them based on the Manufacturer’s recommended intervals.
As per cGMP practices, all online instruments should be calibrated at least once a year. This can be performed with the help of standard solutions and master calibrated instruments having genuine credibility. All instruments should be tagged with the latest date of calibration performed and next date of calibration to be performed for reference.
Key operational checks to ensure an effective UV system performance and microbial control include confirming the UV intensity values, Lamp burning hours, UV intensity dosage calculation with respect to flow rate and microbial results before and after UV sampling points.
Share your equipment queries, raw water parameters or loop requirements. Our engineering team will review your requirements and get in touch within 48 hours to clarify your queries and provide you with our best purity solutions.
