Research And Validation On Purified Water Process

Good Manufacture Practice for Drugs (GMP) has been internationally recognized as a basic standard for drug production and quality management, and GMP Compliance Certification is now a passport for pharmaceuticals trading. The Guideline of Good Manufacture Practice for Drugs (as Guideline) reflects GMP (Ver. 1998). Both GMP and Guideline definite the detail requests to the water technology, and give the pharmaceutical enterprises a new concept and thought. Purified water (PW) and water for injection (WFI) are extremely important for drug production and safety of drug users. So, water should be treated as a material according to the GMP regulation, its specification must be conformed to the request by Pharmacopoeia of People's Republic of China. Based on regulation of GMP, the Guideline and Chinese Pharmacopoeia, the differences among several process systems were discussed, the output water quality, auto-control levels and investment were analyzed, and the technology processe for purified water system sutable for the actual situation was established. Firstly, well water passed the mechanical filter, active charcoaled filter, and precision filter as the pre-treatment equipment, bigger floating particals and bacteria can be removed. Then, the reverse osmosis (RO) equipment was employed to remove over 95% salt and delete 99% pyrogen and bacteria. Finally, the ion exchange (IX) equipment was used to product purified water with 4 MΩ·cm (25℃) with the precision filter as terminal equipment. This system can fit the possible changes that may happen in feed well water. The hardware and the software for PW equipment and management were designed, implemented and certificated, including standard operation practice and documents, the equipment installation and operation. The traditional PW production technology was improved with the combination of fixed RO and IX with perfect GMP certification, and the stability of the PW quality was guarenteed.