Quality control



 Vertical integration management

 The quality of animal serum all production process is under the company's control, including the original serum collection, inspection, processing, packaging, logistics and after-sales service.This vertical integration management can make the production process and products in accordance with Chinese medicine biotechnology association "bovine serum production and quality control guidelines" and requirements of the ISO9001:2008 quality management system.

 Traceability

 We use healthy newborn bovine in the original serum acquisition process, each newborn bovine with a new cow quarantine certificate and certificate of non epidemicarea.We numbered the new born bovine according to the cow's original number to ensure the traceability of products.

 Batch production scale

 Our industrial process using the large capacity hybrid technology, batch production can reach 2000 ~ 2500 litres.

 Low levels of endotoxin and low hemoglobin

 Low levels of endotoxin and low hemoglobin is the key to control the quality of serum.Our company uses the advanced collection and separation technology, which can remove red blood cells effectively.

 Filter filling

 We use high flow membrane filtration technology and including 0.1µm terminal Microfiltration method to completely eradicate the mycoplasma contamination in serum.

 Package bottle

 We use the PET fyrogen-free disposable packaging bottle to pack the serum products.

 γ- rays irradiation serum

 The company can irradiated the serum with γ- rays according to customer's requirement. The process using γ- rays to inactivated virus and mycoplasma in the serum of animals.

 Inspection

 We have a professional inspection team, according to the China pharmacopoeia (2015 edition), the United States pharmacopoeia (USP), 9 CFR to have products inspection.

 Validation

 The company tests and verifies the factory building, facilities, process, inspection, etc. according to "bovine serum production" and "ISO9001 quality management system standards in combination with serum all production process.

 The file system

 As China's first bovine serum production company which is become the "ISO9001 quality management system certificate"we establish a set of effective and appropriate file system according to the standard of ISO9001:2008 standards and the requirements of Chinese society of medical biotechnology of "bovine serum production enterprise standard inspection handbook "