Product Name : BIOPHARMACEUTICAL WATER PURIFICATION

The BIOPHARMACEUTICAL WATER PURIFICATION 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.

WHY DO YOU NEED BIOPHARMACEUTICAL WATER GRADE TREATMENT SYSTEMS?

For obvious reasons, the biopharmaceutical industry is one of the most closely regulated, and each component of a pharmaceutical production process must be carefully purified and monitored to prevent the contamination of products. From research and development to the manufacturing of biopharmaceutical products, biopharmaceutical water purification systems play a fundamental role in every stage of biopharmaceutical operations. The different processes in the pharmaceutical industry require different types of water quality, each with its own testing requirements.

1.Design Reference Standard

The system design ,installation and documentation are fully in line with the GMP regulations and guidelines settled for a pharmaceutical water system.

2. Requirements of GMP on water treatment equipment for pharmaceutical applications:

1. The structure of pharmaceutical water system should be simple,reliable ,and easy to install and disassemble.
2. 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.
3. 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.
4. 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 tested.

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.