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Application scenarios
- Chemical APIs
- chemical preparations
- Chinese herbal pieces
- traditional Chinese patent medicines and simple preparations
- biological drugs
Bio-pharma Purified Water
Solution Overview
We provide a complete solution for biopharmaceutical water treatment. The biopharmaceutical water preparation system follows a modular design concept, based on functional units such as pretreatment, oxidation disinfection, multi-media filtration, RO reverse osmosis, UV disinfection, EDI continuous deionization, and storage and export. In the design, manufacturing, and commissioning process, advanced technology, exquisite craftsmanship, and strict quality control are implemented in each functional unit
Program Features
Comprehensive water system services
Provide full process services including system design consultation, system equipment, GMP verification consultation, upgrade and renovation, operation and maintenance, etc
Internationalization standards
Designed according to the latest Chinese, American, and European pharmacopoeia water quality standards, in compliance with GMP and FDA certification requirements, cGMP, ISPE/FDA guidelines
pre-sales service
URS requirement analysis, design, installation, debugging, verification, and training
Verification consulting services
Provide GMP, FDA validation consultation and system DQ, FAT, IQ, QQ, SAT, PQ validation materials
Data-driven management
Mobile IoT remote monitoring data platform, timely feedback on system operation issues
Matching products
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Cooperative Clients
Solution FAQ
What other supporting services can Qiqin provide besides the equipment itself?
＋ －Qiqin provides comprehensive services for the entire lifecycle of water systems, including pre-sales URS requirement analysis and process design; Installation, debugging, operation training, and GMP verification support during sales; 24/7 remote operation and maintenance, regular inspections, supply of consumables, and system upgrades and renovations for after-sales service. The IoT remote monitoring platform can monitor operating parameters in real time, with an accuracy rate of over 95% for fault warning, ensuring long-term stable operation of the system and allowing you to focus on core production business.
What disinfection methods does the system support? How to choose the most suitable solution for us?
＋ －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.
Can a single system meet both purified water and injection water requirements?
＋ －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.
How can biopharmaceutical companies ensure that their purified water systems can smoothly pass GMP, FDA, and other certifications?
＋ －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.