1）纯化水、注射用水储罐和输送管道所用材料存在有毒、不耐腐蚀风险；2）

1) The materials used in purified water, water for injection storage tanks and transmission pipelines are toxic and not resistant to corrosion; <br>2) The vents of the storage tanks are at risk (hydrophobic sterilization filters that do not lose fibers should be installed); <br>3) Pipe design The installation and installation of the <br><br>CL-POL-FE001 GMP plant facility design review, which has the risk of dead ends and blind pipes, stipulates: <br>--- Purified water and water for injection should be transported by circulating pipelines. The piping design should be concise to avoid blind pipes and dead corners. The pipeline shall be made of stainless steel or a pipeline that has been verified to be non-toxic, corrosion-resistant, and free from contaminated ions. <br>--- The material of the breathing filter installed on the storage tank should be hydrophobic. <br>--- The materials used in the process water system should meet the hygienic level requirements, and the materials should meet the thermodynamic and chemical disinfection requirements. <br>Conclusion: The existing SOP meets regulatory requirements.

1）纯化水、注射用水储罐和输送管道所用材料存在有毒、不耐腐蚀风险；<br>2）储罐的通气口存在风险（应当安装不脱落纤维的疏水性除菌滤器）；<br>3）管道的设计和安装存在死角、盲管风险 <br><br>“CL-POL-FE001 GMP厂房设施设计审核”规定：<br>---纯化水、注射用水应采用循环管路输送。管路设计应简洁，避免盲管和死角。管路应采用不锈钢或经验证无毒、耐腐蚀、不渗出污染离子的管道。<br>---贮存罐上安装的呼吸过滤器的材料应是疏水性的。<br>---工艺用水系统所使用的材料应符合卫生级别要求，而且其材料应符合热力学和化学消毒要求。<br>结论：现有SOP符合法规要求。

1) The materials used for purified water, injection water storage tank and transmission pipeline are toxic and corrosion-resistant;<br>2) There is a risk in the vent port of the storage tank (hydrophobic bacteria removal filter without fiber shedding shall be installed);<br>3) There are dead angle and blind pipe risks in pipeline design and installation<br>"Cl-pol-fe001 GMP plant facility design review" stipulates:<br>---Purified water and injection water shall be transported by circulation pipeline. The pipeline design shall be simple to avoid blind pipe and dead angle. The pipeline shall be stainless steel or non-toxic, corrosion-resistant and non exuding polluted ions.<br>---The material of the breathing filter installed on the storage tank shall be hydrophobic.<br>---The materials used in the process water system shall meet the requirements of hygiene level, and the materials shall meet the requirements of thermodynamics and chemical disinfection.<br>Conclusion: the existing SOP meets the requirements of the regulations.