1) 纯化水、注射用水的制备、贮存和分配系统存在微生物的滋生风险。1）

1) The preparation, storage and distribution systems of purified water and water for injection have the risk of microorganism growth. <br><br>1) "CL-POL-203 Process Water" stipulates: The <br>following aspects should be considered in the design of the water system : <br> The design of the purified water and injection water system must be based on the local drinking water to ensure that the produced water can continue to meet the set quality standards, And can prevent the growth and pollution of microorganisms. <br> Purified water and deionized water can be prepared by appropriate methods such as reverse osmosis, distillation, ion exchange, and ultrafiltration. <br> Water for injection should be prepared by distillation, and its design must ensure that it can remove endotoxin and prevent the subsequent generation of endotoxin. <br> The respirator of the storage tank should be a hydrophobic sterilization filter that does not lose fibers, and can be tested for integrity. <br> Good engineering design should include the use of loop circulation, control of the dead angle of the pipeline, smooth inner surface, suitable materials, control of appropriate flow rate, and the system can be completely emptied. <br> Return water temperature of injection water> 70 ℃. <br>Conclusion: The existing SOP meets regulatory requirements.

1) There is a risk of microbial growth in the preparation, storage and distribution systems for purified water and injection water.<br><br>1) "CL-POL-203 Process Water" provisions:<br>Water system design should take into account the following:<br>Purified and injectable water systems must be designed to ensure that water production continues to meet set quality standards and to prevent microbial growth and contamination, in accordance with local drinking water conditions.<br>Purified water and deionized water can be prepared by reverse osmosis, distillation, ion exchange, ultrafiltration and other appropriate methods.<br>The water for injection should be prepared by distillation and designed to ensure the removal of endotoxins and prevent the subsequent production of endotoxins.<br>The respirator in the tank should be a hydrophobic desterilization filter that does not shed the fibers and is capable of integrity testing.<br>Good engineering design should include the use of loop loop, control of the dead end of the line, smooth internal surface, suitable material, control of the appropriate flow rate, the system can be completely empty.<br>The water return temperature for injection water is 70 degrees C.<br>Conclusion: The existing SOP meets the regulatory requirements. ...

1) The preparation, storage and distribution systems of purified water and water for injection are at risk of microbial growth.<br>1) "Cl-pol-203 process water" regulation:<br>The following aspects shall be considered in the design of water system,<br>The design of purified water and water for injection system must be based on the local drinking water situation, to ensure that the produced water can continue to meet the set quality standards, and prevent microbial breeding and pollution.<br>Purified water and deionized water can be prepared by reverse osmosis, distillation, ion exchange, ultrafiltration and other appropriate methods.<br>The water for injection shall be prepared by distillation method, and its design must ensure that the endotoxin can be removed and the subsequent generation of endotoxin can be prevented.<br>The respirator of the storage tank shall be a hydrophobic sterilizing filter that does not shed fiber and can be tested for integrity.<br>Good design of the project shall include loop circulation, dead angle control of the pipeline, smooth internal surface, proper material, proper flow rate control, complete emptying of the system, etc.<br>Return water temperature of water for injection ＞ 70 ℃.<br>Conclusion: the existing SOP meets the requirements of the regulations.<br>