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Quality requirements for clean room pharmaceutical water
by：PHARMA
2022-05-14
Quality requirements for clean clean room modular pharmaceutical water
Clean room pharmaceutical process water is the water used in the production process, including drinking water, purified water, water for injection, etc.; drinking water is tap water or deep well water supplied by the water company, and cannot be directly used for preparation of preparations or test water ; Drinking water must meet the requirements of 'Living Drinking...
Text label: clean clean room modular design, clean room engineering, quality requirements for pharmaceutical water
Quality requirements for clean room pharmaceutical water
Clean room pharmaceutical process water is the water used in the production process, including drinking water, purified water, water for injection, etc.; drinking water is tap water or deep well water supplied by the water company, and cannot be directly used for preparation of preparations or test water ; Drinking water must meet the 'Sanitation Standards for Drinking Water Quality'. Potable water that needs to be used includes: purified water, raw water of medical water; initial washing of equipment, containers, and oral dosage bottles; water in the initial stage of chemical synthesis; cleaning, infiltration and extraction of Chinese herbal medicines and decoction pieces. Purified water is water obtained by distillation, ion exchange, reverse osmosis or other suitable methods. The pure water must meet the quality standards of purified water. Those that need to use purified water include: water source for preparing water for injection; non-sterile drugs directly Final washing water for contacting equipment, utensils and packaging materials; initial washing of injections and sterile drug bottles; oral preparations and bottle washing; refining of non-sterile drug raw materials.
Water for injection is water prepared from purified water as raw water, distilled in a specially designed distiller, condensed and cooled, and filtered through a membrane; water for injection must meet the quality standards of water for injection, and should meet the requirements of bacterial endotoxin test. Water for injection needs to be used: injections, sterile rinse ingredients and solvents; injections, sterile rinse ingredients and solvent final bottle wash water; sterile products and raw materials that directly contact packaging materials and final wash water. Pure steam uses purified water as the feed water and is heated with steam to produce aseptic and pyrogen-free pure steam. It is widely used in the sterilization and disinfection of the biopharmaceutical industry and the food industry and the disinfection of related appliances. It can effectively prevent heavy metals, pyrogens, etc. Recontamination of impurities. The use of pure steam water includes: materials, containers, equipment, sterile clothing or other items in the sterile work area need to be sterile, warm and sterile treatment in the work area; moist heat sterilization of the culture medium. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for clean rooms and clean workshops.
Using ion exchange, electrodialysis and osmosis to obtain pure water, and then distillation to prepare water for injection; the biggest feature of ion exchange method is the high salt removal rate, but the regeneration of ion exchange resin needs to generate a large amount of waste acid and waste alkali, which seriously pollutes the environment; reverse osmosis is a membrane separation technology, and the removal rate of bacteria, pyrogens and organic matter in water can reach 100%, but its desalination rate is only 90%, and the salt content of raw water is very high. requirements. Electrodialysis is to pass the raw water through a DC electric field, and remove the anions and cations from the electrolyte dissociation in the raw water under the action of an anion and cation exchange membrane and static electricity to obtain purified water. This method consumes a lot of electricity and the salt removal rate is not very high. Primary desalination process from purified water. Purified water process design scheme: the first traditional process, raw water → pretreatment → primary reverse osmosis → mixed bed system → UV sterilization → depyrogenation equipment → reverse osmosis + mixed bed system to obtain purified water; the process is safe and reliable, The water quality is stable, the operation cost is low, and the desalination rate is high. The second new process: raw water → pretreatment → primary reverse osmosis → secondary reverse osmosis → UV sterilization → depyrogenation equipment → secondary reverse osmosis to produce purified water; it is environmentally friendly, wastewater can be directly discharged, and the degree of automation is high. Simple operation, can realize unattended and other characteristics. The third latest process: raw water → pretreatment → primary reverse osmosis → EDI device → UV sterilization → depyrogenation equipment → reverse osmosis + EDI device to produce purified water; green and environmentally friendly, with good water quality, stable water volume, and can achieve Fully automatic, continuous water production, and low labor intensity.
SUZHOU PHARMA MACHINERY CO.,LTD. thinks that that firms can avoid the artificial choice between quantitative and qualitative risk management, allowing both to play important roles in surfacing and assessing risks.
All of the long-term strategies and short-term actions of PHARMA will be molded by a set of core values that are shared by each and every associate.
Our company specializes in manufacturing CUSTOM SOLUTION SERVICES mainly extraction machine.
PHARMA clearly and succinctly expresses what our company is all about. Strong brands cut through the noise to grab the audience and immediately shed light on the character of the product or service.
These extraction machine CUSTOM SOLUTION SERVICES have made the life easier. The best feature of the is its extraction machine.
Clean room pharmaceutical process water is the water used in the production process, including drinking water, purified water, water for injection, etc.; drinking water is tap water or deep well water supplied by the water company, and cannot be directly used for preparation of preparations or test water ; Drinking water must meet the requirements of 'Living Drinking...
Text label: clean clean room modular design, clean room engineering, quality requirements for pharmaceutical water
Quality requirements for clean room pharmaceutical water
Clean room pharmaceutical process water is the water used in the production process, including drinking water, purified water, water for injection, etc.; drinking water is tap water or deep well water supplied by the water company, and cannot be directly used for preparation of preparations or test water ; Drinking water must meet the 'Sanitation Standards for Drinking Water Quality'. Potable water that needs to be used includes: purified water, raw water of medical water; initial washing of equipment, containers, and oral dosage bottles; water in the initial stage of chemical synthesis; cleaning, infiltration and extraction of Chinese herbal medicines and decoction pieces. Purified water is water obtained by distillation, ion exchange, reverse osmosis or other suitable methods. The pure water must meet the quality standards of purified water. Those that need to use purified water include: water source for preparing water for injection; non-sterile drugs directly Final washing water for contacting equipment, utensils and packaging materials; initial washing of injections and sterile drug bottles; oral preparations and bottle washing; refining of non-sterile drug raw materials.
Water for injection is water prepared from purified water as raw water, distilled in a specially designed distiller, condensed and cooled, and filtered through a membrane; water for injection must meet the quality standards of water for injection, and should meet the requirements of bacterial endotoxin test. Water for injection needs to be used: injections, sterile rinse ingredients and solvents; injections, sterile rinse ingredients and solvent final bottle wash water; sterile products and raw materials that directly contact packaging materials and final wash water. Pure steam uses purified water as the feed water and is heated with steam to produce aseptic and pyrogen-free pure steam. It is widely used in the sterilization and disinfection of the biopharmaceutical industry and the food industry and the disinfection of related appliances. It can effectively prevent heavy metals, pyrogens, etc. Recontamination of impurities. The use of pure steam water includes: materials, containers, equipment, sterile clothing or other items in the sterile work area need to be sterile, warm and sterile treatment in the work area; moist heat sterilization of the culture medium. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for clean rooms and clean workshops.
Using ion exchange, electrodialysis and osmosis to obtain pure water, and then distillation to prepare water for injection; the biggest feature of ion exchange method is the high salt removal rate, but the regeneration of ion exchange resin needs to generate a large amount of waste acid and waste alkali, which seriously pollutes the environment; reverse osmosis is a membrane separation technology, and the removal rate of bacteria, pyrogens and organic matter in water can reach 100%, but its desalination rate is only 90%, and the salt content of raw water is very high. requirements. Electrodialysis is to pass the raw water through a DC electric field, and remove the anions and cations from the electrolyte dissociation in the raw water under the action of an anion and cation exchange membrane and static electricity to obtain purified water. This method consumes a lot of electricity and the salt removal rate is not very high. Primary desalination process from purified water. Purified water process design scheme: the first traditional process, raw water → pretreatment → primary reverse osmosis → mixed bed system → UV sterilization → depyrogenation equipment → reverse osmosis + mixed bed system to obtain purified water; the process is safe and reliable, The water quality is stable, the operation cost is low, and the desalination rate is high. The second new process: raw water → pretreatment → primary reverse osmosis → secondary reverse osmosis → UV sterilization → depyrogenation equipment → secondary reverse osmosis to produce purified water; it is environmentally friendly, wastewater can be directly discharged, and the degree of automation is high. Simple operation, can realize unattended and other characteristics. The third latest process: raw water → pretreatment → primary reverse osmosis → EDI device → UV sterilization → depyrogenation equipment → reverse osmosis + EDI device to produce purified water; green and environmentally friendly, with good water quality, stable water volume, and can achieve Fully automatic, continuous water production, and low labor intensity.
SUZHOU PHARMA MACHINERY CO.,LTD. thinks that that firms can avoid the artificial choice between quantitative and qualitative risk management, allowing both to play important roles in surfacing and assessing risks.
All of the long-term strategies and short-term actions of PHARMA will be molded by a set of core values that are shared by each and every associate.
Our company specializes in manufacturing CUSTOM SOLUTION SERVICES mainly extraction machine.
PHARMA clearly and succinctly expresses what our company is all about. Strong brands cut through the noise to grab the audience and immediately shed light on the character of the product or service.
These extraction machine CUSTOM SOLUTION SERVICES have made the life easier. The best feature of the is its extraction machine.
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