Basic knowledge of purified water preparation system in gmp production workshop

Basic knowledge of purified water preparation system in gmp production workshop

Preparation of purified water in gmp production workshops should use potable water as raw water and use appropriate unit operations or combined methods. Commonly used purified water preparation methods include membrane filtration, ion exchange, electrode deionization (EDI), distillation, etc. Among them, membrane filtration is also ...

Text label: GMP production workshop, GMP pharmaceutical cleanroom, workshop purified water preparation system

Basic knowledge of purified water preparation system in gmp production workshop

Preparation of purified water in gmp production workshops should use potable water as raw water and use appropriate unit operations or combined methods. Commonly used purified water preparation methods include membrane filtration, ion exchange, electrode deionization (EDI), distillation, etc., of which membrane filtration can be subdivided into microfiltration, ultrafiltration, nanofiltration and reverse osmosis (RO).

Reverse osmosis unit (Reverse

Osmosis, RO) adopts reverse osmosis, the most sophisticated membrane liquid separation technology, which is a semi-permeable membrane that only allows water molecules to pass through and does not allow solutes to pass through. The membrane materials used in the purified water preparation process are mainly cellulose acetate and aromatic polyamides. When the pretreated water enters the reverse osmosis system, most of the ions and bacteria can be removed, and microorganisms and TOC can be effectively removed at the same time, so as to meet the high standard water quality requirements of continuous and stable low conductivity and low bacterial content.

A typical reverse osmosis system includes reverse osmosis feed pump, scale inhibitor dosing device, reducing agent dosing device, 5μm security filter, heat exchanger, high pressure pump, reverse osmosis device, CO2 degassing device or NaOH dosing device Medicine device and reverse osmosis cleaning device, etc.

①Water pump The function of the high pressure pump is to increase the inlet pressure of RO to make it higher than the osmotic pressure of water.

②Scale inhibitor and reducing agent dosing device Whether it is necessary to install scale inhibitor and reducing agent dosing device in the purified water preparation system depends on the actual situation of raw water quality, pretreatment process selection and user requirements.

③Security filter prevents the passage of particles larger than 5μm and protects the RO membrane from damage.

④The maximum working temperature of the reverse osmosis membrane of the heat exchanger is 25℃, and the heat exchanger is usually required to adjust the water temperature.

⑤CO2 degassing device CO2 gas can almost completely permeate the RO membrane, too much CO2 will lead to an increase in the conductivity of the produced water.

Electrodeionization (EDI) device is a system combining electrodialysis process and ion exchange process. The working principle of EDI is to use mixed ion exchange resin to adsorb anions and cations in water. At the same time, these adsorbed ions are removed through anion and cation exchange membranes respectively under the action of a DC electric field.

The selection of the purified water preparation process in the gmp production pharmaceutical cleanroom needs to consider the following factors: the quality of raw water (usually municipal water supply), the owner's requirements for water quality, measures to prevent microbial contamination and disinfection, equipment operation and the professionalism of operators Quality, adaptability and reliability of raw water quality changes in different seasons, convenience of daily maintenance of equipment, recovery rate of produced water of equipment and treatment of waste liquid discharge, daily operation and maintenance cost, and monitoring ability of the system. Zhongjing Global Purification can provide consulting, planning, design, construction, installation and transformation of GMP workshops, purification workshops, sterile workshops, medical equipment workshops, clean rooms and other supporting services.

The pretreatment unit generally includes multiple units such as multi-media filter, activated carbon filter, softener and so on. The main purpose of the pretreatment unit is to remove insoluble impurities, soluble impurities, organic matter and microorganisms in the raw water, so that the main water quality parameters meet the water inlet requirements of the subsequent purification system, thereby effectively reducing the workload of the subsequent purification system and preventing pollution to the purification system. or irreparable damage.

Multimedia filters are mostly filled with quartz sand, and the quartz sand should be filled in order from the bottom to the top according to the particle size. The Shimei sand layer is filled with anthracite or green sand. Its main function is to remove large particles of impurities and suspended solids in the water.

Activated carbon filter mainly uses filled activated carbon and active free radicals to remove harmful substances such as free chlorine, chromaticity, organic matter and some heavy metals in water.

The main function of the softener is to remove the hardness of the water, such as calcium ions and magnesium ions, through the sodium-type softening resin, so as to prevent calcium, magnesium and other ions from scaling on the surface of the RO membrane. The softening resin needs to be regenerated to restore its exchange capacity, so a two-stage series softening system is usually used in the design to ensure the continuous operation of the purified water machine.

The purification system generally has various processes such as RO→RO→EDI, RO→RO, RO→EDI and so on. The purification system 'purifies' the pretreated water into purified water that meets the requirements of the Pharmacopoeia and the internal control of the pharmaceutical factory through the key process of deionization, reduction of organic matter, microorganisms and endotoxins. The ability to remove residual chlorine is the main indicator of activated carbon.

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