Solution to unqualified purified water in the pharmaceutical industry
Release time:2022-08-01
Pharmaceutical purified water is used in the pharmaceutical industry, so all indicators of pharmaceutical purified water should meet the requirements of the new version of the Chinese Pharmacopoeia GMP certification. There is a certain difference between purified water and deionized water. Deionized water removes all ions produced by electrolyte dissolution in water, except for hydrogen ions and hydroxide ions. Purified water, on the other hand, undergoes purification equipment to remove various substances from the water without any additives. Removing ions from the water is just one of the steps. From this, it can be understood that deionized water can achieve the purity of purified water, but it may not necessarily be achievable in terms of bacteria.
Purified water is generally obtained through purified water equipment and used in pharmaceutical production processes, so the quality must meet relevant standards. So, how to store purified water and how long does it last?
In order to ensure the quality of purified water usage, we must understand the storage time of purified water, use it up within its validity period, and ensure that the storage conditions meet the standards. The storage period of purified water should not exceed 24 hours. So what are the standard conditions? Below, the editor of Binrun purified water equipment will provide a detailed introduction for everyone!
Purified water is stored in specially designed purified water storage tanks, which are usually made of stainless steel or other materials that have been verified to be non-toxic, corrosion-resistant, and do not leak out pollutants. The storage tanks should be made of stainless steel or other materials that have been verified to be non-toxic, corrosion-resistant, and protected by hydrophobic sterilization filters that do not shed fibers. The inner wall of the storage tank should be smooth, and there should be no dead corners or sand holes in the connecting pipes and welds. Sensors that do not cause stagnant water pollution and display parameters such as liquid level, temperature, and pressure should be used. Regularly clean, disinfect and sterilize storage tanks, and verify the effectiveness of cleaning and sterilization.
Purified water, as the main water source in the pharmaceutical industry, will seriously affect the quality of drug production if the nitrate produced by purified water equipment is not qualified. Today, let's explore the reasons for the unqualified nitrate in purified water and try to avoid problems fundamentally.
The phenomenon of unqualified nitrate in purified water is manifested as: qualified conductivity, excessive nitrate or nitrite, usually caused by microbial contamination, such as contamination of pre-treatment systems and reverse osmosis systems, affecting performance, resulting in incomplete water quality treatment, uncleanliness of purified water equipment storage tanks and pipelines, and secondary pollution of produced water quality, leading to the occurrence of excessive nitrate or nitrite.
And what we need to do when using purified water equipment is to regularly clean the purified water equipment and test the nitrate index of the purified water regularly to avoid serious impact on drug production caused by substandard water quality. We can learn about relevant information on how to solve the problem of excessive nitrate in purified water. Once there is a situation of unqualified nitrate in purified water, it should be resolved in a timely manner.