Medicinal purified water equipment

　　Medicinal purified water equipmentDetails:

Water is a large and widely used raw material in drug production, used in the production process and the preparation of drug formulations. The raw water for pharmaceutical use is usually drinking water, which is purified from natural water and its quality must comply with the People's Republic of China standard GB5749-85 "Sanitary Standards for Drinking Water". Pharmaceutical water is very important for the pharmaceutical industry. The preparation of pharmaceutical water should comply with the requirements of production quality management standards, including production design, material selection, preparation process, storage, distribution, and use. With the advancement of scientific testing technology and the increasing demand of the people for drug quality, the preparation and testing methods of pharmaceutical water are keeping pace with the times. This article describes the concept and testing methods of pharmaceutical water.

1Medicinal purified water equipment: Pharmaceutical water

The Chinese Pharmacopoeia Appendix specifies the concept of pharmaceutical water, which is divided into three categories based on its scope of use: a) purified water, b) injection water, and c) sterilized injection water. In the United States Pharmacopeia, there are seven types of medicinal water, four more than in the Chinese Pharmacopoeia: a) sterilized purified water, b) antibacterial injection water, c) sterilized infusion water, and sterilized inhalation water.

Requirements for injection water: Use drinking water or purified water as raw material water, and prepare it by distillation or reverse osmosis method. The final processing steps of distillation and reverse osmosis methods have been established since USP19 in 1975.

Requirements for sterilized purified water: Purified water for packaging and sterilization, mainly used for sterilization preparations other than large quantities of non intestinal drugs.

Requirements for sterilized injection water: Injection water used for packaging and sterilization should be packaged in a single dose of no more than 1L.

Requirements for antibacterial injection water: Used for injection water containing antibacterial agents, used as a diluent for non intestinal drug preparations, can be packaged in single or multiple doses, with a packaging capacity of no more than 30ml. When using, its compatibility with injection drug preparations should be considered, and it should not be used for newborns.

Requirements for sterilization infusion water: Sterilization infusion water is injection water packaged in sterilized single dose for infusion, with a packaging capacity greater than 1L.

Requirements for sterilized inhalation water: Sterilized inhalation water is suitable packaged injection water that has been sterilized and used for inhalation therapy.