The pollution risks that affect the quality of injection water are microorganisms andpyrogen!It includes both exogenous and endogenous pollution’External pollution is the feed water of the injection water system(((Pollution caused by purified water and external factors entering the system!Like exhaust portDrainage outlet or contact with external pollution due to system leakage)The main endogenous pollution may be the water treatment unit equipment&Design of Storage and Distribution System&material selection&install&run&Improper maintenance and use can promote the survival of microorganisms&Caused by the proliferation of biofilms’Therefore!How to optimize the design of injection water system reasonably is the key first step in controlling the quality of injection water from microbial and pyrogen pollution’

Basic principles and characteristics of design

The basic principles that should be followed in the design of injection water systems are*go outThe water quality meets the requirements specified in the pharmacopoeia!Reliable system operation monitoring!fuckEasy maintenance and low operating costs’In order to produce qualified injection water!The basic characteristics of the design of injection water system are*Change from traditional one-way flow to circulating reflux!Adopting rigorous disinfection and sterilization facilities’ The contents and interrelationships of the injection water system

The injection water system can be divided into the preparation of injection water&Storage, distribution, disinfection and sterilization three parts!This requires the use of distilled water preparation equipment that can produce distilled water that meets quality requirements!Effective control of microbial growth and reproduction is required in storage and transportation systems!And within a certain period of time!Clean, disinfect and sterilize the injection water system based on water quality monitoring’ Optimization Design of Injection Water System

The key to optimizing the design of injection water system is the operation mode of injection water preparation&Storage and distribution methods for injection water!And cleaning, disinfection, and sterilization methods!Its purpose is to prevent and suppress the growth and reproduction of microorganisms in the system!To avoid ultimately causing substandard quality of injection water during operation’ Operation mode and preparation of injection water

The operation mode of preparing injection water is crucial for the production of injection water!Current European Pharmacopoeia regulations*Distilled water machine

The first part of production, distilled water, should be discarded!Then collect the distilled water after the second round’Thus it can be seen!Under certain conditions of injection water usage and storage capacity!How to ensure that the distilled water machine is in continuous water production operation!One of the issues that cannot be ignored in obtaining a constant injection water quality is!It can avoid fluctuations in water quality that may occur due to continuous on-off operation!Or due to improper operation!Mixing unqualified water into qualified water’Can the distilled water machine operate continuously and the system's water production capacity&Storage

The amount of water is related to the amount of water used!In terms of process production management!It should be based on the usage period of each water point&Water consumption and duration!Strive to achieve a relative balance of water consumption throughout the entire system at different time periods as much as possible'Insufficient or excess parts rely on water storage tanks for adjustment#!To match the water production capacity of the distilled water machine!I hope to be able to operate continuously in a more ideal dynamic manner with a smaller distilled water machine.Preparation of injection water

The preparation of injection water is the source of water quality assurance for injection water systems!Only by preparing injection water that is qualified and minimizes the presence of microorganisms and pyrogens as much as possible'Due to the lack of absolute sterility#!To reduce the burden of measures to be taken to control microbial contamination in the storage and distribution system of injection water!Only then can the contamination of the storage and distribution system by microorganisms and pyrogens be reduced to a lower level’usually!The preparation of injection water should pay full attention to the following issues* Selection of Preparation Methods for Injection Water

From the perspective of process flow!There may be distillation method for the production of injection water&againstThree methods: infiltration and ultrafiltration’ Distillation method uses purified water as feed water!By heating and evaporating&steamThe processes of liquid separation and condensation achieve the purification of chemical substances and microorganisms in water!Theoretically!It can effectively remove bacteria from water&hotOriginal and most other organic substances!And the method is simple&easy to do&canrely on!Therefore, this law is included in the pharmacopoeias of various countries!It is a method for preparing injection water both domestically and internationally’