In the design, validation, and operation of pharmaceutical purified water equipment systems, people often encounter various problems. The following will classify the raw water required for the preparation of purified water, water production equipment, system operation, and detection of purified water, and analyze some common problems, providing reference for the design and application of pharmaceutical purified water equipment systems in practice, and avoiding these problems from recurring.

1. Raw water

Before starting the design of pharmaceutical purified water equipment systems, a crucial step is to understand the actual situation of the water source. If the source water does not meet the national drinking water standards, it needs to be treated into drinking water that meets the national standards, and then the drinking water needs to be prepared into purified water. The design of pharmaceutical purified water system should be based on the ion content and microbial indicators of the raw water, as well as the water production demand of the designed water system. That is to say, the raw water of the pharmaceutical purified water equipment system should at least meet or be treated to drinking water standards, and its supply capacity should be greater than the production capacity of the purified water equipment.

2. Water production equipment

In pharmaceutical purified water equipment, all materials in contact with purified water are generally 316L or other materials that match their performance. Choosing the appropriate material can reduce the possibility of microbial growth in pharmaceutical purified water systems, and this is also to facilitate regular passivation operations in the future.

Due to the increased microbial load in the water system caused by dead corners, the pipeline design and installation of pharmaceutical purified water equipment should avoid dead corners and blind pipes. In addition, the design of purified water flow rate and flow engineering is aimed at achieving turbulent state. The water system should not have a high flow rate, as high flow rates can lead to problems such as excessive pressure loss, pipeline vibration, and large valve opening and closing impact force.

3. System operation

The pharmaceutical purified water system should pay attention to maintaining the existing state during operation, in order to achieve the goal of continuously and stably producing purified water that meets the standards. The storage and distribution system of pharmaceutical purified water equipment generally requires regular disinfection. Common disinfection methods include chemical disinfection, ozone disinfection, and thermal disinfection. It is generally safe and cost-effective to store and distribute water at room temperature and undergo periodic thermal disinfection. The frequency of disinfection mainly depends on the system design. In addition, factors such as water volume, usage frequency, and water temperature in the system can also affect the frequency of disinfection. The simplest disinfection method currently is to heat the circulating treated water in the distribution system to around 80 degrees Celsius and maintain it for a period of time.

4. Detection of purified water

The detection methods for purified water mainly include offline measurement and online measurement. The items with significant differences in measurement values between the two methods are mainly conductivity and TOC. Because carbon dioxide in the air dissolves into water and generates conductivity due to the action of ions. There is a possibility of contamination from sampling, sampling containers, and environmental factors in TOC offline measurement, which differs significantly from the online values. From the accuracy of data and the trend of technological development, online measurement is superior to offline measurement.

In the entire process of preparing purified water for pharmaceutical use, due to the high susceptibility of water to the growth of microorganisms, effective measures should be taken in design, installation, validation, operation, measurement, and other aspects to effectively control microbial indicators and address common problems in the preparation process, in order to meet the quality requirements of pharmaceutical purified water.

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