埃及求购蒸馏水(Pharmaceutical Multi Stage Distilled Water Unit)
"We are searching for a complete (GMP model) Multi-stage Distilled Water unit to produce pyrogen free water for injection (WFI) that meets all the requirements of pharmacopoeia of Europe and USA with the following specifications:
1- The capacity of this multi-effect distilled water machine varies from 250 to 750Kgph.
2- At least four columns better if five columns.
3- Electrical heating or any other technology to reduce power consumption (please advise).
4- Including a 1 m3 double jacketed electrically heated tank (water for injection storage tank) with electrical and visual level controllers.
5- Pyrogen free circulating pump running at 80DegC temperatures.
6- Also including sanitary pipes* (50 m long distributed as table *** all with tri-clamp end fitting), Elbow (90Deg) (QTY 25, with tri-clamp end fitting), 3-way valves (Zero dead leg with tri-clamp end fitting) (QTY 4).
7- Heat exchanger especially for the use of water for injection at the point of use to reduce the temperature from 80DegC to 30DegC (QTY 2).
All the above should be made from Stainless Steel 316, with orbital welding.
Please determine if you can provide for all of the above the FAT, SAT documentation and also the DQ, IQ, OQ, PQ.
Hint our raw water for this unit is RO water.
Pharma Swede Egypt is a multinational pharmaceutical company (Manufacturing Veterinary Medicine) Located in Egypt. We are considered as one of the biggest veterinary medicine manufacturer company in Egypt and in the Middle East. We also were nominated as Exporter no. 1 in the Veterinary medicine in Egypt for the Year 2009.
* Sanitary pipes (50 m long distributed as table below all with tri-clamp end fitting):
No. Length of pipe QTY
1 3m 15
2 2m 20
3 1m 15
The unit is aimed to be acting as the following scheme:
RO water - Multistage Distillation Unit - Hot WFI pyrogen free water 80DegC - pyrogen free pump running at 80DegC - Stainless Steel Loop using sanitary pipes - Usage point through Heat exchanger - return back to a double jacketed heated storage tank - part of hot circulated WFI water is to be used again in the Multistage Distillation Unit to maintain continuous sterility and 80DegC temperature (case dependant). "