The distribution system is the core unit of the whole pharmaceutical water system, and its main function is to ensure that the pressure, flow and temperature delivered to the process pipeline meet the process production requirements. The system uses online monitoring instruments such as flow, pressure, temperature, conductivity and TOC to conduct safety performance, real-time monitoring and trend analysis of water quality, and effectively control the load of microorganisms in water through periodic disinfection or sterilization. In addition, sampling valves shall be installed on the water supply starting point, water pipeline and end pipeline of the entire distribution system for water quality sampling. The whole system is mainly composed of inverter, exchanger, sampling valve, diaphragm valve, sanitary pipe fittings, online monitoring instrument and other supporting control systems.
The storage and distribution system of pharmaceutical water includes storage unit, distribution unit and water point pipe network unit. The design of pharmaceutical water distribution system has various forms, and the basic idea is to minimize the operation risk and microbial risk at a reasonable cost.
The storage unit is used to store pharmaceutical water meeting the requirements of the pharmacopoeia and meet the maximum peak consumption requirements of the system. The storage system must maintain the quality of water supply, so as to ensure that the quality of the end use of the product is qualified.
Circulating design is adopted for the pharmaceutical water supply pipeline.The main function of the distribution system is to deliver pharmaceutical water meeting the requirements of the Pharmacopoeia to the process water point, and ensure that its pressure, flow and temperature meet the requirements of process production or cleaning.
The storage and distribution units need to be disinfected regularly to reduce the possibility of microbial breeding.
PW storage and distribution system must be disinfected regularly. Automatic control mode is recommended. The common disinfection methods for purified water storage and distribution system are as follows: 1. Pasteurization; 2. Ozone disinfection
WFI storage and distribution systems must be sterilized regularly. Automatic control mode is recommended. Common sterilization methods of WFI storage and distribution system are as follows: 1. Pure steam sterilization; 2. Sterilization with superheated water
Maintaining Water Quality
Preventing Contamination: A properly designed system minimizes the risk of microbial contamination, ensuring the water remains pure and sterile.
Preserving Chemical Purity: The system safeguards the water's chemical purity, preventing the introduction of contaminants that could compromise the quality of products.
Ensuring Reliable Supply
Continuous Supply: The system ensures a consistent and uninterrupted supply of purified water to various points of use, optimizing production processes.
Buffering Demand Fluctuations: Storage tanks can help buffer against fluctuations in demand, preventing shortages and ensuring a steady supply.
Optimizing Operational Efficiency
Reduced Downtime: A reliable water supply minimizes downtime due to water quality issues or shortages.
Increased Productivity: A well-designed system can improve overall productivity by streamlining processes and reducing the time spent on water quality testing and treatment.
Compliance with Regulatory Standards
Adherence to GMP: The system must comply with stringent Good Manufacturing Practices (GMP) regulations to ensure product quality and safety.
Meeting Regulatory Requirements: It helps meet the specific quality standards set by regulatory agencies like the FDA, EMA, or local authorities.
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