Quality Assurance

Company Profile

Xi'an Sippex Kejie Ltd.is a Sino-French joint venture high-tech enterprise located in the eastern district of Xi'an High-Tech Industrial Development Zone, China. The company covers an area of over 5,000 square meters and is equipped with fully automatic and semi-automatic high-frequency bag production lines and tubing accessory manufacturing lines imported from Europe. Its production workshop is ten-thousand and partial hundred level clean room, and its facilities are strictly complied with the CFDA GMP standards.

The company is specialized in the research and production of medical soft packaging containers, including cryostore freezing bag,(registration number at CFDA: B20210000793), cell culture bag, PD solution bag, irrigation bag, IV bag (registration number: Guoyao Baozi 20120235). All products meet the standards of the European Pharmacopoeia (EP) and more than 20 invention and utility model patents were created.

Enterprise Honor

荣誉资质

CPPIA Award Certificate

Member of CPPIA

Excellent enterprise

Model Workers’ Home

Excellent entrepreneur

Social Responsibility Excellent enterprise

Excellent Foreign-Funded Enterprise

View the video to learn about us

Adhering to the business philosophy of quality first and customer first

Sippex Kejie established quality system ISO 9001 in 2015. Raw materials was finely selected from the Europe. GMP standards, Cleanness 100 and 10,000 class. Compliance with the European pharmacopeia. The manufacturing process and all inspections is as described in the drug master file DMF92-67. CFDA ( Chinese Food & drug Administration )registered (Guoyaobaozi 20120235),Regarding the pharmaceutical packing materials and pharmaceutical excipients to apply for association approval with drug, the announcement No.134, 2016 of CFDA stipulates that the pharmaceutical packing materials which got the approved pharmaceutical registration certificate doesn’t need to registrate again after the certificate expires, it can be continue to use in previous drug, or apply for new registration with other drug. ISO9001 certified by Intertek.