Biopharmaceutical Purified Water Solution

Qiqin offers multiple disinfection methods to choose from: activated carbon pasteurization, CIP cleaning system, distribution system ozone sterilization, distribution system pasteurization, and distribution system pure steam sterilization. The selection criteria include: production process (whether regular disinfection is required), material tolerance (SUS304L/SUS316L can be tolerated), water point distribution, etc. Our technical team will communicate fully with you during the URS stage and recommend the optimal disinfection solution based on GMP risk assessment.

Absolutely possible. Qiqin adopts a modular combination design, which can configure different functional units according to your needs: basic purified water adopts dual stage RO+EDI; Injection water can be supplemented with multi effect distillation or pure steam sterilization modules on the basis of purified water. The system distributes water of different water qualities through storage and export units, achieving multiple uses for one machine and meeting the differentiated needs of different workshops such as chemical raw materials and biological agents.

Qiqin follows the latest Chinese, American, and European pharmacopoeia standards from the design source, and the system fully complies with GMP, FDA certification requirements, and ISPE/FDA guidelines. We provide full process validation services, including URS, DQ, FAT, SAT, IQ, OQ, PQ and other complete validation documents. All functional units have undergone strict confirmation. At present, we have assisted multiple listed pharmaceutical companies such as Shengxiang Biotechnology in obtaining domestic and international certifications in one go, with a stable water resistivity of 18.25M Ω. cm, TOC<5ppb, and microorganisms<0.1cfu/ml, which are all superior to pharmacopoeia standards.