Medical pure water field

Medical pure water field

Pharmaceutical pure water

GMP is a set of mandatory standards applicable to the pharmaceutical, food and other industries, requiring pharmaceutical, food and other production enterprises to have good production equipment, reasonable quality management and strict testing systems to ensure that the final product quality (including food safety and hygiene, etc.) meets regulatory requirements. As a good solvent, water is the most widely used process raw material and the top priority of quality control. In particular, purified water that has lost balance with nature has extremely strong solubility and very few impurities, and is often used as a component of medicines, solvents, and equipment cleaning.

The Chinese Pharmacopoeia defines purified water as: This product is water for medicinal use obtained by distillation, ion exchange, reverse osmosis or other appropriate methods, and does not contain any additives.

v Application areas covered

1) Medical device production (Class I, Class II, Class III)

2) In vitro diagnostic reagents

3) Pharmaceutical industry (infusion, biopharmaceuticals, Chinese patent medicines)

v Case 1 ()

(1) Water output: 1000L/H

(2) Water production standard: in line with the purified water standard of the 2020 edition of the Chinese Pharmacopoeia and the YY/T1244 in vitro diagnostic reagent water standard.

(3) Process introduction:

Raw water → Raw water tank → Raw water pump → Multi-media filtration → Activated carbon filtration → Security filtration → Primary high-pressure pump→pH dosing device→ Primary reverse osmosis device → Secondary high-pressure pump → Secondary reverse osmosis device → Secondary water production tank → EDI booster pump → EDI device → Sterile pure water tank → Delivery pump + UV sterilization + precision filter → Water point