Pharmaceutical process water in GMP workshop
Pharmaceutical process water in GMP pharmaceutical cleanroom
The preparation of process water in the GMP workshop should meet the requirements of production quality management standards in terms of production design, material selection, preparation process, storage, distribution and use; the water production system should be verified, and daily monitoring, testing and Reporting system, with perfect original records...
Text label: GMP workshop process water, purification plant pure water equipment
Pharmaceutical process water in GMP workshop
The preparation of process water in the GMP workshop should meet the requirements of production quality management standards in terms of production design, material selection, preparation process, storage, distribution and use; the water production system should be verified, and daily monitoring, testing and Reporting system, complete original records for future reference, water storage containers and pipes should be regularly cleaned and sterilized by appropriate methods. The preparation of purified water in the GMP pharmaceutical cleanroom consists of three parts: pretreatment, desalination and post-treatment. In the production of water, due to the possibility of various pollutions, special attention should be paid to whether there is microbial contamination for each production unit. The parts and the water flowing out should be monitored frequently; the purpose of raw water pretreatment is to completely or partially remove impurities such as suspended solids, microorganisms, colloids, dissolved gases and some organic substances in the raw water, to create conditions for desalination and post-treatment processes, and to achieve electrodialysis , reverse osmosis, particle exchanger and other influent water quality requirements.
Pretreatment includes adding coagulant and mechanical filtration. The raw water contains suspended solids and colloidal substances, and its surface is negatively charged. It can only be removed by coagulation after electrical neutralization. Therefore, high-priced cationic or macromolecular polymerization is often added. The materials are mixed by a spiral pipeline mixer, and then contacted and agglomerated by a multi-media filter to become larger, and most of them can be removed by filtration. Mechanical filtration adopts mechanical filter. The mechanical filter is mainly multi-media filter, iron-casting filter and activated carbon adsorber. Multi-media filter is mainly used to remove suspended impurities in water. The equipment shell is made of high-quality carbon steel. Natural rubber or other anti-corrosion layers, the equipment is equipped with a water distributor, and the built-in medium generally adopts double-layer filter material. In order to prevent the filter material from passing through the filter water cap, the bottom layer is a quartz sand cushion with a particle size of 1.6-3.2mm; multi-media Filter operations include filter media cleaning, forward washing and running, and backwashing. In addition to the function of the multi-media filter, the iron filter can also adsorb and remove a small amount of iron ions in the water. It is suitable for the pretreatment of raw water containing iron ions. If there are special requirements, the shell can be made of plastic or stainless steel. The lower layer of the activated carbon adsorber is quartz sand cushion, and the rest are Φ2mm*5mm granular activated carbon. Because it is filled with activated carbon with huge specific surface area and strong adsorption force, it can absorb free chlorine in water and has a high removal rate of organic matter and pigment. , generally used in combination with a multi-media filter; the operation of the activated carbon adsorber includes: activated carbon pretreatment, normal operation, backwashing, positive washing, and replacement of activated carbon. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and purification plants.
The structure design of the process water preparation device in the GMP workshop should be simple, reliable, and easy to disassemble. The surface of the outer wall should be smooth and flat, easy to clean and sterilize. The surface of the parts should be treated with chrome plating to resist corrosion and rust. Avoid using paint on the outside of the equipment to prevent peeling. Purified water can be used as washing water for ophthalmic preparations, extraction solvent for eye drops, etc., but not as a solvent for preparing eye drops. Purified water is water without any additives obtained from pretreated raw water by distillation, ion exchange, reverse osmosis or other suitable methods; ion exchange is generally used in electrodialysis desalination equipment to remove salt It can be removed to meet the requirements of deionized water, and the effluent resistivity can be controlled at 1-18MΩ.cm.
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