Introduction to the process principle of pharmaceutical purified water equipment?Ii. Purified water equipment in line with GMP certification in the pharmaceutical industry:
The monomer and pipeline equipment meet the requirements of GMP (for example, UPVC pipe is used for the pipeline of back-end processing equipment such as sterilizer, membrane filter, terminal water tank and pretreatment equipment).
The water quality conforms to the standard of pharmacopoeia 2000 and the provisions of GMP
Automatic operation of equipment and conditional automatic processing procedures (such as backwash, regeneration and disinfection procedures)
GMP certified pharmaceutical water requirements
1. Requirements of GMP on water preparation equipment for biological pharmaceuticals:
(I) equipment design requirements
1. The structure design should be simple, reliable and easy to disassemble and assemble.
2. In order to facilitate disassembly, replacement and cleaning of parts, standardization, universalization and systematization of parts should be adopted in the design of actuator as far as possible.
3. The inner and outer wall surfaces of the equipment shall be smooth and without dead Angle, easy to clean and sterilize.The surface of parts should be chrome plated and other surface treatment, in order to resist corrosion and prevent rust.Avoid using paint outside the equipment to prevent peeling.
4. The equipment for preparing purified water shall be made of low-carbon stainless steel or other materials that have been proved not to pollute the water quality.Equipment for preparing purified water shall be cleaned regularly and the cleaning effect shall be verified.
5. Materials in contact with wfi must be high-quality low-carbon stainless steel (such as 316L stainless steel) or other materials that have been proven not to pollute water quality.The equipment for preparing wfi should be cleaned regularly and the cleaning effect should be verified.