Requirements for water configuration in pharmaceutical and medical device processes

1、 Material requirements for process water system

Process water systems made of 304 or 316L stainless steel that meet hygiene standards should be used.

2、 Structural composition of process water system

In general, the purified water process water system mainly includes the raw water pretreatment part, desalination part, post-treatment part, and storage and distribution part. The raw water is generally drinking water, and the pretreatment part includes raw water storage tanks, multi-media filters, activated carbon filters, resin softeners (or dosing and scale inhibition equipment), filters (5 μ m), etc; The desalination part mainly consists of equipment such as reverse osmosis or (EDI or ion exchange); The post-processing part includes disinfection and sterilization devices such as ultraviolet and ozone generators; The storage and distribution section includes purified water storage tanks and transfer pumps. The injection water production device not only has a purified water process water system, but also includes a distiller, and the storage and distribution part also includes an injection water storage tank. Among them:

（1） Equipment for pre-processing:

Sand filtration (multi-media) is required for raw water with high suspended solids content; When the hardness of the raw water is high, a softening process needs to be added; The organic matter content in the raw water is relatively high, and coagulation and activated carbon adsorption need to be increased. If activated carbon filters are selected, it is required to install backwashing and disinfection devices for organic matter; The chloride ions in the raw water are relatively high. To prevent the impact on subsequent processes such as ion exchange and reverse osmosis, it is necessary to add oxidation-reduction (NaHSO)₃）Processing; CO in raw water₂When the content is high, a degassing device is used; There are many bacteria, and it is necessary to use chlorine, ozone, or ultraviolet sterilization.

（2） Equipment for desalination:

The deionization device should be regenerated online, and the tanks, pumps, pipes, valves, and measuring instruments required for the loading, unloading, storage, and transportation of acids and alkalis should be corrosion-resistant; If a reverse osmosis device is used, a 3-5 μ m filter needs to be installed at its inlet; Before the water from the mixed bed enters the purified water tank directly, a 3-5 μ m filter should be installed to prevent small resin residues from entering. The filter should be equipped with a differential pressure gauge; The purified water from the mixed bed can maintain circulating flow and stabilize the water quality, and a conductivity meter should be installed on the circulating pipeline.

（3） Equipment for post-processing:

The intensity of ultraviolet sterilization light decays over time, and there should be a light intensity detection or time recorder for regular cleaning or replacement of the ultraviolet lamp tube; Regular backwashing devices should be installed for mixed beds of anions and cations, reverse osmosis devices, and EDI devices; The pipeline materials for pre-treatment are often made of pressure resistant and corrosion-resistant materials such as ABS engineering plastics. After precision treatment facilities such as reverse osmosis high-pressure pumps, stainless steel materials are usually used for pipelines.