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Aims to become a giant in the global blood products industry


Product safety record

By the end of 2016, Shanghai RAAS had produced and sold more than 30 million vials of plasma-derived products, without a single case of virus contamination or serious adverse incident reported due to the product quality.  Our products have been on the market for more than 20 years, and their quality and safety have been proven. This excellent track record has garnered Shanghai RAAS the reputation of a top brand in China.   The production of Human Serum Albumin, Intravenous Immunoglobulin, Human Coagulation Factor VIII, Human Prothrombin Complex Concentrate, Human Fibrinogen and other products have 100% pass record since government implemented mandatory batch release procedures. 

Stringent source plasma testing

Plasma from healthy donors in China is collected by automated plasmapheresis machines, and a 60-day quarantine period coupled with a tracking system are employed to eliminate viral infection through a "window period".  Our laboratories carry out testing for viral markers 8 times and all these tests are in accordance with US-FDA and the WHO - recommended standards.

• 5 times: EIA test (Enzyme-Linked Immune-Sorbent Assay) for HBsAg, Anti-HCV, Anti-HIV1+2.

• 3 times: Nucleic Acid Amplification technique (NAT) for HBV-DNA, HCV-RNA and HIV-RNA.

Strict sterilization process

Our production employs a modified low-temperature ethanol fractionation process in order to prevent microbial growth.  The products also undergo heat treatment during plasma protein separation and purification process. Through rigorous validation tests, we use various specification filters under fully closed conditions to eliminate completely the possibility of product contamination.

Virus inactivation/removal

Shanghai RAAS employs at least two of the following steps of virus inactivation/removal for each product:

• Pasteurization method

• Low pH incubation method

• Chemical Solvent/Detergent (S/D) treatment

• Dry Heat method

• Viral removal Nano-Filtration method

Virus inactivation/removal methods described above are effective inactivation/removal procedures for lipid-enveloped and non-enveloped viruses, and are all validated by Chinese National Institute for  the  Control of  Pharmaceutical and Biological Products (NICPBP) as well as by international authorities.

Links:Tonrol Bio-Pharmaceutical Co., Ltd.,

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