This segment of the chemical processing industry must deal with levels of cleanability and sterility that will ensure the safety of those who use or make the products.
As the world’s populations grow and age, developing countries expectations rise and new research brings new health solutions to the world, the biopharmaceutical (biopharm) industry flourishes. Like all chemical processing, biopharm has its own set of standards, special processing needs and challenges in materials and design.
THE CHEMICAL INDUSTRY
At its most general level, one can define the chemical industry as the aggregate of entities engaged in processing raw materials using chemical reactions (often aided by pressure and/or forms of energy such as heat) to convert those materials into products. That general level has numerous subgroups, such as biopharmaceutical, organic/inorganic chemicals, industrial gases, petrochemicals, agrochemicals, polymers and paints. These subgroups are categorized further by the end-product goods and commodities such as dyes, acids, alcohols, fertilizers, hydrogen, nitrogen, herbicides, ammonia, soaps, detergents, hair sprays, enamels, varnishes and many more.
Commonly, the processes required to manufacture these products use constituents or conversion enablers that are toxic, or they result in products and byproducts that may be toxic themselves. The inputs and outputs to those processes can present additional challenges because of physical and chemical properties that can make media extremely corrosive or abrasive. Also, the media can be difficult to propagate and control throughout the process flow in situations where physical/chemical properties result in media that is semi-solid.
In each segment of the industry and in every subcategory of these segments, valves play a critical role. A variety of valves are appropriate for various applications and deployed for handling different types of media. Covering the entire industry is too great a task for one article. Therefore, the information that follows highlights where and how valves are used in chemical processing for the biopharm market.
The biopharm industry can be divided into two segments: Pharmaceutical, which uses chemical processes to manufacture therapeutic and health-related products; and biotechnology (biotech), which uses living organisms and biological processes to create products used in many fields such as pharmacology, medicine, agriculture and many others. A primary example is therapeutic protein used for medical and therapeutic applications. Most biotech applications involve cell cultures of genetically modified organisms including yeasts, insect cells, bacteria cells or mammalian cells.
A full range of pumps, valves and instrumentation comparable to other processing systems can be used in the biopharm industry. However, stringent requirements regarding cleanability and materials of construction mean that some products that perform ordinary and useful flow control functions in other applications must either be used with great caution or not used at all. An example is check valves. Check valves are installed tentatively because even sanitary check valves allow formation of “dead areas,” despite the fact they are functioning according to specifications. Such areas potentially harbor contaminants or toxic agents.
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