Фармацевтическая система водоснабжения

Purified Water
Generator equipment

• Design the most optimal process according to raw water quality, including combinational design of various processes.
• Modular design, easy for operation and spare parts replacement & maintenance.
• Improved technology makes water generation rate higher than 85%.
• Special multi-port valve design, meet requirement of zero dead angle.
• Capacity can be automatically adjusted during the cycle, to reduce energy consumption.
• Ensure from the process inspection and monitoring to final validation documents meet GMP requirement.

WFI Generation device

• Economical efficiencywith good running reliability and long time operation .
• Water infeed spraying design, with uniform distribution , and non- condensable gas Removing
• Distillation column expansiontechnology, no damage to stainless steel material , with stable running for long time
• 3 level separation method, to get high quality WFI and pure steam
• Self-sterilization design, meet with cGMP requirement
• High standard equipmentdocument and validation document , meet validation requirements of WHO/ EUGMP/ FDA/cGMP

Pure Stream Generator

• Quick response touser’s capacity ( <30с)
• Stability of pure steam output pressure(±5 %)
• Output range of puresteam pressure: 2~5 barg
• Capacity PID proportionalcontrol
• Typical waste dischargingrate:2-8 %
• Very lowrunning cost
• Quality of pure steammeet requirement of noncondensable gas content , saturation(dryness) ,degree of super heat
• requirement defined inHTM2010( EN285)

Water Distribution System

• No dead anglein distribution pump chamber discharge valve
• Compact structure, with small floor space
• Fully automatic runningand sterilizing system
• Modular design,convenient for FAT and SAT
• Hot water/Ozonesterilization method are as option for PW distribution
• Hot water/Pure steam sterilization method are as option for WFI distribution

Производство и гарантия качества

Возможности обработки

Валидация и документирование

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