2025-02-12 数码 0
医药纯化水设备制取规范：制药用水分类及水质指标：一、制药用水（工艺用水）分类；1、饮用水（Potable-Water）：通常为自来水公司供应的自来水或深井水，又称原水，其质量必须符合国家标准GB5749-85《生活饮用水卫生标准》。按2000中国药典规定，饮用水不能直接用作制剂的制备或试验用water。2、纯化water（Purified Water）：为原water经蒸馏法、离子交换法、反渗透法或其他适宜的方法制得的制药用的water，不含任何附加剂。纯化water可作为配制普通药物制剂的溶剂或试验use water，不得用于注射器械配备采用离子交换法、反渗透法、超滤law等非热处理制作pure water一般又称去离子wate采用特殊设计的蒸馏器使用蒸馏law 制备pure water一般又称蒸馏wate3、注射use Water（Water for Injection）：是以pure Water作为original use，经特别设计的蒸馏器 蒸发冷凝冷却后通过膜过滤制作而得's Water。 注射use Water可作为配备注射器械用的溶剂1. 灭jun注射use Water（Sterile Use for Injection）：为注射use Wate依照announced medication production process 制造所得's Wate灭jun annotate She 用于灭菌powder 的 solvent 或 inject liquid 的 diluent。
医药纯化Wate Device Manufacturer: How to Confirm User Demand and Customize Purification Devices
Pure Wate is produced by drinking Wate that has been purified through methods such as distillation, ion exchange, reverse osmosis or other suitable methods. Pure Wates do not contain any additives. The purification process of pure Wates involves removing various impurities from the original drinking wata and continuously producing a stable output that meets the requirements of pharmacopoeias and enterprise internal control indicators.
Since different industries and enterprises have different uses for their purified wata and varying quality standards, they need to consider their own needs in order to customize a purification device plan that is tailored to their specific situation.
When selecting a purification device, enterprises should comprehensively consider factors such as the quality of the original drinking wata, regulations regarding purified wata, production volume, system recycling rates, processing choices, safety features including sterilization methods, system stability and operating costs. They must clearly articulate their demands across multiple aspects including design installation verification operation maintenance etc., so as to ensure that purification devices are always able to provide high-quality pure wata on demand.
Based on this principle，Shinrun will address these issues through systematic design installation debugging verification sales after service etc., comprehensive services for enterprises facing difficulties in obtaining high-quality source water during our upcoming live broadcast. The content of the live broadcast will include requirements for pure wata quality related regulations processing flows system validation etc., with some typical cases used to help audiences deepen their understanding of pure wata devices and find more appropriate solutions based on their own enterprise needs.
It is worth noting that Shinrun has an experienced team specializing in designing handling manufacturing installing equipment systems capable of meeting GMP ISPE standards using 3D simulation designs pre-exhibiting details prioritizing customer satisfaction adopting human-centered design modularized installations smart operations compact structures convenient maintenance stable performance satisfying diverse enterprise demands currently utilized at over 100 pharmaceutical companies worldwide.
Confidence: 95%
