Introduction to GMP Purified Water

Equipment used to produce purified water to meet medical needs. The entire system is constructed entirely of stainless steel, and sterilization equipment is required before each water point. Using processes such as reverse osmosis and EDI, a comprehensive high-purity water treatment process is designed to meet the purified water production and large-volume infusion requirements of pharmaceutical factories and hospitals.

Purified Water Process Flow

Raw water → Raw water tank → Raw water booster pump → Multi-media filter → Activated carbon filter → Cationic water softener → Precision filter → First-stage booster pump → First-stage reverse osmosis → Intermediate water tank → Second-stage booster pump → Second-stage reverse osmosis → Purified water storage tank → Purified water booster pump → Ultraviolet sterilizer → Microporous filter → Water point

Water used in the production of biological preparations, pharmaceuticals, medical devices, and cosmetics.

Solvents or laboratory water for preparing pharmaceutical preparations; solvents or diluents for oral or topical preparations; cleaning water for instruments used in non-sterile preparations; solvents for extracting medicinal herbs used in non-sterile preparations; solvents or diluents for preparing injectables; cleaning water for injection containers; cleaning water for medical devices; water for cosmetics production; and water for disinfectant wipes production. Water effluent standards comply with relevant national regulations.

Purification water equipment parameters

Purified water equipment must meet certain requirements:

1. The structural design of GMP purified water equipment should be simple, reliable, and easy to assemble and disassemble.

2. To facilitate assembly, disassembly, replacement, and cleaning of parts, actuator design should utilize standardized, universal, and systematic components whenever possible.

3. The interior and exterior surfaces of the equipment must be smooth, flat, and free of dead corners, ensuring easy cleaning and sterilization. Parts should be chrome-plated or treated to prevent corrosion and rust. Avoid using paint on the exterior of the equipment to prevent peeling.

4. GMP purified water equipment should be constructed of low-carbon stainless steel or other materials proven to be non-contaminating. GMP purified water equipment should be cleaned regularly, and the cleaning effectiveness verified.

5. Materials that come into contact with water for injection must be high-quality low-carbon stainless steel (such as 316L stainless steel) or other materials proven to be non-contaminating. Equipment used to prepare water for injection should be cleaned regularly, and the cleaning effectiveness verified. 6. Purified water produced by GMP purified water equipment should not be stored for more than 24 hours. Storage tanks should be constructed of stainless steel or other materials proven to be non-toxic, corrosion-resistant, and non-leaking of contaminating ions. Protect the vents with a non-shedding, hydrophobic sterilizing filter. The interior of the reservoir should be smooth, with no dead corners or holes in the pipes or welds. Sensors that display parameters such as liquid level, temperature, and pressure should be used and should not cause stagnant water contamination. The reservoir should be cleaned, disinfected, and sterilized regularly, and the effectiveness of the cleaning and sterilization procedures should be verified.

Application Areas