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E-mail
1403163800@qq.com
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Phone
18913123961
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Address
1st Floor, Block B, Building 6, No. 88 Changwang Road, Dongqiao, Huangdai Town, Xiangcheng District, Suzhou City
Suzhou Kaixu Purification Equipment Co., Ltd
Process principle of GMP purified water equipment
Date: 2025-04-11Read: 7
The process principle of GMP purified water equipment is based on multi-level physical and chemical treatment technology, and achieves water purification through modular combination to ensure compliance with the Chinese Pharmacopoeia and GMP standards. The core process can be divided into the following three parts:
1、 Preprocessing system
1. Multi media filtration
By using filter media such as quartz sand to remove suspended solids, sediment, and other large impurities from raw water, turbidity can be reduced.
2. Activated carbon adsorption
Utilize the adsorption effect of activated carbon to remove residual chlorine, organic matter, and off color odors.
3. Softening treatment
Using sodium type cation exchange resin to replace calcium and magnesium ions, reducing the hardness of water and preventing subsequent equipment scaling.
2、 Core purification system
1. Reverse osmosis (RO) technology
Primary reverse osmosis: By driving water molecules through a semi permeable membrane under high pressure, more than 90% of inorganic salts, colloids, and microorganisms are intercepted.
Secondary reverse osmosis (optional): further removes residual ions, improves water purity, and is commonly used in high demand scenarios.
2. Electrodeionization (EDI)
By combining ion exchange resin and electric field, ion impurities can be continuously removed without chemical regeneration, and the water production resistivity can reach 15-18 M Ω· cm.
3、 Post processing and Loop System
1. UV sterilization
254 nm ultraviolet radiation destroys microbial DNA, achieving non chemical disinfection and avoiding secondary pollution.
2. Micro porous filtration/ultrafiltration
Adopting a 0.2-0.45 μ m pore size filter membrane to intercept microorganisms and particles, ensuring sterile water quality at the end.
3. Cyclic sterilization
By regularly circulating high temperatures above 80 ℃ or ozone, the growth of microorganisms in the distribution system is inhibited, which meets the dynamic water quality requirements of GMP.
4、 Process characteristics and standards
1. Modular design: pre-processing RO/EDI、 The storage and distribution system operates independently to avoid cross contamination.
2. Online monitoring of water quality: Real time detection of key parameters such as conductivity and TOC to ensure compliance with the purified water indicators specified in the pharmacopoeia (such as conductivity ≤ 5.1 μ S/cm).
3. Material compliance: The pipelines and storage tanks are made of 316L stainless steel, with electrolytic polishing on the inner walls, meeting GMP requirements for easy cleaning.
This process achieves stable conversion from raw water to high-purity water through a multi-stage barrier design, while balancing energy efficiency and operational reliability, providing regulatory compliant water quality assurance for pharmaceutical production.
