project

Process Description

1. Classification and water quality indicators of pharmaceutical water

Pharmaceutical water (process water: water used in the production process of drugs, including drinking water, purified water, and water for injection)

Drinking water (Potable-Water): usually tap water or deep well water supplied by the water company, also known as raw water, its quality must meet the national standard GB5749-85 "Sanitary Standards for Drinking Water". According to the 2000 Chinese Pharmacopoeia, drinking water cannot be directly used as water for the preparation or testing of preparations.

Purified water (Purified Water): It is water for pharmaceutical use obtained by distillation, ion exchange, reverse osmosis or other appropriate methods of raw water, without any additives. Purified water can be used as a solvent or test water for the preparation of ordinary pharmaceutical preparations, and shall not be used for the preparation of injections.

Water for injection (Water for Injection): It is water prepared by using purified water as raw water, distilling it in a specially designed distiller, condensing and cooling it, and filtering it through a membrane. Water for injection can be used as a solvent for the preparation of injections.

Sterile Water for Injection: Water prepared according to the injection production process. Sterile Water for Injection is used as a solvent for sterilized powder or a diluent for injection.

2 .Water quality standards for pharmaceutical water

2.2.1 Water quality standards for pharmaceutical drinking water: in line with the national standard of the People's Republic of China "Sanitary Standards for Drinking Water" (GB5749-85)

2.2.2 Water quality standards for pharmaceutical purified water: in line with the "2000 Chinese Pharmacopoeia"

Chemical indicators: in line with the requirements of pharmaceutical purified water in the 2000 edition of the Pharmacopoeia of the People's Republic of China

Hygiene inspection: microorganisms 10CFU/100ml

Endotoxin 0.25EU/ml

Conductivity ≤2μS/cm (resistivity ≥ 0.5 MΩ*CM)

The resistivity of purified water used for flushing injection and eye drop containers should be ≥1MΩ.CM/25℃

2.2.3 Water quality standards for pharmaceutical injection water: in line with the injection water standards included in the 2000 Chinese Pharmacopoeia

Purified water preparation and extraction station 8T/hr: using two-stage reverse osmosis process, all stainless steel pipelines, equipped with touch screen human-machine interface.