Industrial water for syringes

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Industrial water for syringes plays a crucial role in pharmaceutical production. In order to ensure the quality of medicines, pharmaceutical factories need to use high-quality process water, including drinking water, purified water, water for injections, and sterile water for injections. The quality requirements for pharmaceutical water are defined and standardized in pharmacopoeias around the world. Pharmaceutical water has a direct impact on the quality of medicines, so the pharmaceutical industry needs to have strict design, validation, and maintenance of preparation, storage, and distribution systems.

Preparation of purified water:
Common methods for preparing purified water in the pharmaceutical industry include membrane filtration, ion exchange, electro-deionization, and distillation. The purification system for pharmaceutical water generally consists of a pretreatment system and a purification system. The purpose of the pretreatment process is to remove sources of contamination in the membrane system, such as suspended solids, organic matter, microorganisms, and insoluble salts. The purification system removes impurities such as inorganic salts, bacteria, endotoxins, and organic macromolecules from the water through processes like reverse osmosis membranes and electro-deionization. In the process of preparing purified water, factors such as the quality of the feedwater, the quality of the produced water, the reliability of equipment operation, microbiological contamination control measures, equipment maintenance, and ease of operation need to be comprehensively considered.

Preparation of water for injections:
In the pharmaceutical industry, water for injections is mainly prepared using distillation. Multi-effect distillation machines are widely recognized and used by pharmaceutical companies. They remove impurities and microorganisms from the water through multiple evaporation, condensation, and separation processes. The design of distillation machines needs to consider factors such as disinfection or sterilization methods, material selection, and temperature control. The quality requirements for water for injections are strict, with endotoxin control within 0.25 EU/ml. The storage and distribution system for water for injections needs to be properly designed, including storage units, distribution units, and network units at usage points. The design needs to consider key points such as the selection of storage tank size, disinfection methods for storage and distribution systems, temperature detection, flow rate detection, conductivity detection, and total organic carbon (TOC) detection.

Design of storage and distribution systems:
The design of storage and distribution systems needs to consider factors such as product characteristics, investment costs, equipment operation and maintenance costs, and operational risks. Storage systems use tanks, temperature sensors, level sensors, and respirators to store and maintain the quality of pharmaceutical water. Distribution systems use sanitary centrifugal pumps, heat exchangers, pipelines and fittings, diaphragm valves, sampling valves, sensors, and other equipment to transport pharmaceutical water to process water points and maintain the pressure, flow rate, and temperature required for the process. The design of storage and distribution systems can be selected based on factors such as temperature requirements at usage points, disinfection methods, and system scale. Key points to consider during design include temperature detection, flow rate detection, conductivity detection, TOC detection, alarm functions, pipeline materials, and welding methods.

In conclusion, industrial water for syringes plays a crucial role in pharmaceutical production. Pharmaceutical companies need to choose appropriate preparation processes and design schemes for storage and distribution systems based on pharmacopoeia requirements and production needs to ensure the quality and safety of the produced medicines. The rational design and operational management of industrial water for syringes are of vital importance to the development of the pharmaceutical industry.

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