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Hygienic piping manufacturers are facing new challenges

Posted: 11/14/2018 16:44:53 Hits: 24

Hygienic piping can be used for transporting high-purity liquids and gases between equipment in the pharmaceutical industry, where has specific requirements for the materials of pipes with respect to ensuring that fluids won't be contaminated and the pipes won't be corroded during the transporting process. With the refinement of GMP (Good Manufacturing Practices), the pharmaceutical industry put forward a higher requirement for pipe manufacturing technique and brings new challenges to the pipe industry.

It is understood that hygienic pipes can be roughly divided into two types: pipes for API (Active Pharmaceutical Ingredient) and pipes for chemical agents, or subdivided into pipes for pharmaceutical water system (purified water piping, pure steam piping, injectable hydrogel piping), pipes for industrial media system (hygienic compressed air piping, vacuum piping, nitrogen, industrial steam piping, high and low temperature media piping, etc.), water supply and drainage piping, industrial alcohol piping, and so on.

According to experts, compared with API field, media that transport in pharmaceutical preparation field are relatively common and are primarily centered on soften water, purified water, injectable hydrogel, pure steam, industrial compressed air, etc. But some of them may need high or low temperature circulation, or relatively high pressure, so the technique requirements are very high.

Based on Good Manufacturing Practices, the concept of cleanliness should take priority in manufacturing pipes for pharmaceutical preparation industry, especially for controlling and preventing microorganisms. It is necessary to strictly abide by the related regulations of pipes in Chinese GMP, and FDA (Food and Drug Administration) and European GMP if the products are going to export.

There are other components in piping system, such as pipe fittings, valves, gaskets, etc. According to the new Chinese GMP, valves, pipe fittings and gauges of the processing pipes should be compatible with the materials of the pipes. One is that the piping system can have better corrosion resistance and two is that it can prevent electrochemical corrosion.

In hygienic piping system, stagnant water should be tried to avoid, which requests specific requirement for valves, among which the most used valves in the pharmaceutical industry are diaphragm valves, as its special design can achieve no contact with any other fittings except gaskets and thus reach the goal of clean environment. In the installation process of diaphragm valves, the self-discharging function of them should take into consideration, that is, to ensure a certain installation angle.

The way in which the pipes are connected is very important. In some connection measures, stagnant water is easy to cause when errors occur, which will violate the GMP to a great extent. Some experts suggest that in order to prevent the risk of microbial growth, when designing hygienic piping for the pharmaceutical industry, it must be noted that the piping system is in the empty state, and water or other media in the system can be fully discharged. In addition, choose different methods to handle different kinds of installation form.

Besides, the roughness of the inner surface of pipes also plays an important role in the stainless steel piping for pharmaceutical use. In the design process, the corresponding technique should be settled to ensure the roughness. The contact surface of pipes that use for pharmaceutical water or other products must be cold rolled, passivated, mechanical-polished, or electropolished to make sure that the roughness of the inner surface of pipes is less than 1μm.

For saving money, some companies in the market use gaskets made by inferior materials that cannot withstand high temperature, which will easily break and affect the production in the pharmaceutical industry. Therefore, the risk and materials should be taken into account when choosing gaskets for high-temperature system and not merely that system.

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