Multi Column Distillation Plant , Pure steam generator, WFI storage and WFI distribution loops system
Shree Bhagwati having wide experience in Design, Manufacture, exported ,Supply, Installation, Commissioning and Validation of Purified / WFI Storage and Distribution System. Shree Bhagwati WFI Water Systems with its more than 30 year vast experience stands out as turnkey solutions provider for Purified Water , Water for Injection (WFI) storage & distributions systems, Pure and Clean utilities distributions systems for Pharma, Healthcare, Lifesciences & Cosmetics industries..
Our quality standard foundations / Regulatory bodies across the globe such as USFDA, UKMCA, MHRA, WHO and Water for Injection with loop manufacturing system which is compliant guidelines like USP, ASME-BPE, cGMP, GMP With experience of serving the different industry for over 30 years, we have successfully installed & commissioned varied range of customized offerings in India as well as abroad.
Largest Pharmaceutical water system process machine facility of ASIA. Vapor compression system, Multi-column distillation units, Purified water units, Pure steam units, Solution preparation tanks system.
Multi Column Distilled Water (WFI) Plant designed to produce Low Conductivity 100% Pyrogen / Endotoxin free Water for Injection which confirms to IP/BP/EP/USP standard wide Range – 50 LPH to 6000 LPH.
- Manufactured as per cGMP, FDA Guidelines.
- Double Tube Sheet Construction of Column where Boiler Steam is Present.
- All Heat Exchanger tubes will be Seamless quality.
- All parts in the plant coming into contact with WFI and Pure Steam are electro polished, pipe joints are orbitally welded.
Automation – Latest PLC based 21 CFR Part 11 complied fully automatic Control – One Renquist extra Optional we provide.
While it is important to be flexible to meet your variable demands and customization, standardization of systems is also important for tested design and reduced building and construction time. Our standardized systems have been designed keeping in mind specific customer needs wherein the customer can select from the standard designs.
Multi Column Distillation Plant is a key system for Injectable cGMP standard. Multi Column Distillation Plant is the perfect solution for high purity sterile pyrogen free distilled water.
- Pre-Treatment Systems: MGF, Softeners, Pre-Ultra filtration, First Pass RO
- Post-Treatment Systems: Second Pass RO, EDI, Post-Ultra filtration
- Storage & Distribution Systems: Purified water, Highly Purified water, Water for Injection
- Piping and Installation: Sterile piping of clean utility, pendants, point of use heat exchangers
Our system design complies with cGMP, USFDA, EHEDG, WHO Norms. These regulations specify standard of purity for RO, WFI, Highly Purified Water and other kind of Pharmaceutical Waters. Range of our Activities:
- PO/WFI Aseptic Storage Tank with required Accessories & Instrumentation
- SS Distribution Skid with Aseptic distribution Pumping Unit, UV Light, Cartridge Filters etc
- SS 316L EP Piping distribution network with consumer loops having sterile Zero Dead Leg draw off valves.
- SS Control Skid with Automation System
- CIP/SIP Facility for Tank, Pump & Piping
- SS Pendants
Pure steam generator with WFI generation capability, WFI storage and WFI distribution system with hot and tempered loops.
WFI generation with two WFI storage and distribution loops.
WFI storage and distribution systems are custom designed to meet the specific requirements of Injection manufacturing application & also based on application demand. WFI storage & related looping is always designed as per consumption & timely demand of WFI in entire injection manufacturing plant. There is a great demand of optimization of water demand along with validation adherence so that cost of assemble, start up is reduced.
Documentation for all components is also incorporated into a comprehensive turnover package. Our substantial experience is WFI looping management & its erection has resulted in its least deviation from PQ (Process Qualification) parameters. This WFI looping system typically include :
- Pure steam generator.
- WFI tank with spray ball.
- WFI distribution pump.
- Sanitary Heat exchanger and utility valves.
- Vent filter.
MAIN INSTRUMENTATION INCLUDE:
- TOC analyzer(s).
- Conductivity monitors.
- Sanitary valves.
- WFI tank level control.
- Pressure transmitters.
- Flow transmitters.
- Cooling and heating control loops.
- Tank level control.
- Temperature monitoring.
- Material of the parts connected with the water – AISI 316 L
- Roughness of inner surface – < 0,8 µm
- Joint – Tri – Clamp
- Welding method – orbital welding using pure argon not filling cable (manual welding only in inaccessible place)
- Test method – endoscopy (10 % from orbital joint & 100 % from manual joint)
- All tubes & pipe are Electro polished & seamless
- All fittings are TC or DIN standards .