Solution to unqualified purified water in the pharmaceutical industry

In the pharmaceutical industry, the quality of purified water is directly related to drug safety, and any indicators that are not up to standard may lead to serious consequences. The following will focus on the core issue of unqualified purified water, deeply analyze the reasons for nitrate exceeding standards, and provide targeted solutions. At the same time, storage standards will be clarified to ensure the safe use of purified water.

1、 The essential difference between purified water and deionized water

Deionized water mainly removes ions produced by electrolyte ionization in water, except for hydrogen ions and hydroxide ions; Purified water is thoroughly treated with professional equipment to remove various substances from the water, without any additives. It not only reduces ion concentration, but also strictly controls indicators such as microorganisms and organic matter. Therefore, although deionized water can achieve a certain purity, it may not meet the standards for purified water in terms of bacterial control, making it difficult to directly apply in pharmaceutical production.

2、 Storage standards and time limits for purified water

Purified water needs to be stored in specially designed storage tanks, which should be made of stainless steel or materials that have been verified to be non-toxic, corrosion-resistant, and do not leak out pollutant ions. The ventilation port must be equipped with a hydrophobic sterilization filter that does not shed fibers to prevent microbial contamination. 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; The design of sensors for parameters such as liquid level, temperature, and pressure also needs to avoid the formation of stagnant water pollution. To ensure water quality, storage tanks need to be regularly cleaned, disinfected and sterilized, and the effectiveness of cleaning and sterilization should be verified. Under the above storage conditions, the storage period of purified water should not exceed 24 hours to avoid a decrease in water quality due to prolonged storage time.

3、 Analysis of Reasons for Excessive Nitrate in Purified Water

When the conductivity of purified water is qualified but the nitrate or nitrite exceeds the standard, it is often caused by microbial contamination:

Pre treatment and reverse osmosis system pollution: If the pre-treatment system (such as multi-media filters, softeners) or reverse osmosis membrane components are contaminated by microorganisms or organic matter, their filtration performance will significantly decrease, resulting in incomplete water quality treatment and inability to effectively remove impurities such as nitrate.

Secondary pollution: Poor cleaning of purified water storage tanks and pipelines can lead to the proliferation of residual microorganisms and organic matter on the inner walls under suitable conditions, contaminating the stored purified water and causing excessive nitrate or nitrite content.

4、 Solution to the problem of nitrate exceeding the standard

1. Comprehensive cleaning and disinfection of the system: Conduct deep chemical cleaning of the pretreatment system and reverse osmosis system, and select appropriate cleaning agents to remove pollutants; At the same time, ozone and pasteurization methods are used to sterilize purified water storage tanks and pipelines, thoroughly killing microorganisms and eliminating the risk of secondary pollution.

2. Replace damaged components: If key components such as reverse osmosis membranes cannot be restored due to severe pollution, they should be replaced in a timely manner to ensure the filtration effect of the equipment.

3. Strengthen daily monitoring and maintenance: increase the frequency of nitrate indicator testing to control water quality from the source; Regularly inspect and maintain all aspects of the purified water equipment, promptly identify and address potential issues.

4. Optimize operating parameters: Adjust the pre-treatment process and reverse osmosis system operating parameters reasonably according to changes in raw water quality, such as appropriately reducing the reverse osmosis recovery rate, reducing the accumulation of pollutants on the membrane surface, and improving water purification efficiency.

The pharmaceutical industry must strictly control the quality of purified water, manage the entire process from storage to production in a standardized manner, and promptly respond to issues such as excessive nitrate, in order to ensure the safety and reliability of drug production and be responsible for patient health.