2025-02-12 行业资讯 0
医药纯化水设备制取规范：制药用水分类及水质指标。首先，需明确制药用水的分类和对应的质量标准。一、饮用水（Potable-Water）：通常是自来水公司提供的自来水或深井水，也称为原水，其质量必须符合国家标准GB5749-85《生活饮用水卫生标准》。根据2000年版中国药典规定，饮用water不能直接用于制造药品或作为实验室试验用的溶剂。
二、纯化water（Purified Water）：由原water经蒸馏法、离子交换法、反渗透法或其他适宜方法制备而成，是一种不含任何添加剂的制药用water，可用于配制普通药物或者作实验室试验，但不能用于注射剂生产。
三、注射use water（Water for Injection）：是以纯化water为原料，经过特定的蒸馏器进行蒸馏，然后冷凝冷却并通过滤膜过滤得到的一种特殊类型的pure water，可以用于配制注射剂。
1.灭菌注射use water（Sterile Water for Injection）：是一种在注射剂生产过程中通过特定工艺得到的无菌注射use water，可作为灭菌粉末溶液或稀释注射液使用。
对于如何确认用户需求并定制pure water equipment，这是一个复杂的问题。由于不同的行业和企业有着不同的需求和对water quality 的要求，因此需要结合实际情况来确定所需equipment。在选择和安装pure water equipment时，还需要考虑多个因素，如original water quality, regulations, production volume, system recovery rate, process selection and safety.
因此，滨润基于user's use of pure water as the starting point, through systematic design, installation and commissioning, validation and after-sales maintenance services to help enterprises solve the problem of high-quality use of pure water. The content of this live broadcast includes the requirements for pure water quality, related regulations, process flowcharts and system validation methods.
With a team experienced in designing treatment processes for pharmaceuticals and manufacturing medical devices that meet GMP standards from ISPE guidelines. The company uses 3D simulation designs to showcase device details before installation. It also adopts human-centered design principles with modular installations and smart operation systems to ensure stable output while reducing costs.
Currently over 100 pharmaceutical companies have used these purification systems developed by this manufacturer.
