With the national standardization of medicine and health management process, the pharmaceutical industry GMP process of accelerating the medical water and process water requirements gradually improved, the quality of water has become the key to quality control of pharmaceutical production.
Purified water is a medical institution preparation and even the drug preparation industry in the most widely used, huge amount of a raw material and cleaning agent, its quality control is particularly important, is directly related to the quality of pharmaceutical products, the first factor as well as the process medium, has been "Chinese Pharmacopoeia" contained.
Purified water testing and inspection based on the Chinese People's **** and the State Pharmacopoeia, the Pharmacopoeia updated every five years, the overall requirements for purified water is also increasingly stringent. Manufacturers must ensure that the quality of purified water in line with the Pharmacopoeia requirements, but the Pharmacopoeia for purified water is actually only the minimum level, to meet the Pharmacopoeia's standards do not necessarily guarantee compliance with the requirements of the intended use of the enterprise. Currently, the testing of purified water testing is based on the People's Republic of China *** and the National Pharmacopoeia 2020 Edition II.
Chinese Pharmacopoeia purified water testing and inspection agency
China Tech Inspection
Familiar with the purified water testing standards and testing project requirements, can provide professional and reliable purified water testing services, including pharmaceutical purified water, sterilized purified water, medical purified water, etc., to issue a professional and credible purified water testing report.
Purified water testing projects include
The properties, pH, nitrate, nitrate, ammonia, conductivity, total organic carbon, easy oxides, non-volatile matter, heavy metals, bacterial endotoxins, microbial limit (total aerobic bacteria), etc.
Purified water in the production, storage, transportation and use of the process, is very easy to be contaminated by microorganisms, and microorganisms or their metabolites can seriously affect the quality of drugs, causing adverse consequences. Therefore, the daily testing of water quality is an important work of the quality inspection department.