Product Name : 1000 Liter-H Single RO EDI Purified Water System
The pharmaceutical water system is designed to produce purified water
in accordance with the existing Chinese Pharmacopoeia(2010 version),FDA
and United States Pharmacopoeia(USP--36),Drinkable water is used as the
inlet raw water ,after pretreatment and purification ,the drinkable
water is made into pure water which meets requirements of URS.
1.Design Reference Standard
The system design ,installation and documentation are fully in line
with the GMP regulations and guidelines settled for a pharmaceutical
2. Requirements of GMP on water treatment equipment for pharmaceutical applications:
- The structure of pharmaceutical water system should be simple,reliable ,and easy to install and disassemble.
- For the ease of disassembling ,changing and cleaning parts ,the
design of actuating mechanism should adopt standardized ,universal
,systematized components and parts as much as possible.
- The inner and outer surface of the pharmaceutical water system
should be smooth with no dead corner ,easy to clean and sterilize
.Surface of parts should be chrome plated or treated in other ways for
preventing corrosion and rusting .Avoid using paint on the outer surface
of equipment to prevent peeling.
- The material which contacts with injection water must be high
quality low-carbon stainless steel or other proven material that will
not cause pollution to water quality .The injection water production
equipment should be periodically cleaned and the cleaning effect be
5. The storage period of pure water should not be more than 24 hours
,and its storage tank should be made of stainless steel or other
material which have been proven to inhibit the formation of biomembrane
,resist corrosion ,be easy for chemical sterilization and not to release
contaminative ions .The vent should be installed with hydrophobic and
degermed filter which will not drop fiber.Storage tank inside surface
should be smooth.Joint pipes and soldering seam should not have ded
corners and blowholes .A good sensor should be the one that can display
liquid level ,temperature,pressure and other parameters but will not
cause stagnant water pollution .Storage tank should be periodically
cleaned and sterilized ,and the effect of cleaning and sterilization
should be tested.
3.Transport of water for pharmaceutical purpose
1 The pure water and pharmaceutical water should be transported by
SS pump,which is easy to install,disassemble and get sterilized ,In the
case that pure water and injection water are transported by compressed
air and nitrogen ,the compressed air and nitrogen should be purified .
2 The pure water should be transported by circulation line .Design
of pipeline should be simple ,avoid blind pipes and blind angles
.Pipeline should take SS pipes and other tubing which has been proven to
be non-toxic,corrosion resistant,without leakage of contaminative ions
,It is recommended to take sanitary grade valves .Please mark flow
direction when transport pure water .
3 The transport pump and pipeline for transporting pure water and
injection water only can be used after being prevent to be qualified
.The also should be periodically cleaned and sterilized.