Key Factors that Impact the Bioreactor Vessels

      KEY FACTORS THAT IMPACT THE DESIGN, CONSTRUCTION CONSIDERATIONS, AND STEPS INVOLVED IN QUALIFICATION AND VALIDATION OF BIOREACTOR VESSELS     by (Name)     The Name of the Class (Course) Professor (Tutor) The Name of the School (University) The City and State where it is located The Date   Key Factors That Impact the Design, Construction Considerations, and Steps Involved in Qualification and Validation of Bioreactor Vessels A bioreactor vessel is an enclosed and controlled space where biological reactions can occur without external disturbance (Zhong, 2011). It is a valuable tool in any laboratory that researches or relies on biological processes, including proteomics, cell culture, and cell biology. Bioreactors can either be made out of glass or by use of stainless steel. Those made using stainless steel are useful because they allow the maintenance of high internal pressure. On the other hand, the choice of glass is motivated by the need to observe the contents without necessarily opening the bioreactor. Further, assemblies can be added to the reactor vessel to allow processes like stirring, adding or removing samples, and monitoring conditions like temperature and pressure. When choosing a bioreactor vessel, some factors to consider include the size needed, the type of reactions to be accommodated, and whether they are single-use or reusable. While these considerations help in the selection process, they do not shape the design, construction, and qualification processes. Instead, they are the outcomes of these stages of application of bioreactors. As a result, the current paper explores the key factors that impact a bioreactor vessel design, the applicable construction considerations, and the steps involved in the qualification and validation of bioreactor vessel designs. The paper will first discuss the developments that have taken place to arrive at modern bioreactors, the key classes and types of bioreactors, and the steps in a typical bioprocess reaction. The purpose of these sections is to provide a visual image of what bioreactors are, what they entail, how they work, and the subsequent control systems. These sections will inform the subsequent sections on the factors that influence design, construction, qualification. Section 1: About Bioprocess and Bioreactors A bioprocess is a process that relies on complete living cells to obtain desired products. Bioprocesses often involve cell culture in which cells are removed from an organism and placed in conditions where such cells can grow and multiply to assist in research and experiments. Fermentation (of food particles – brewing) is also a fundamental aspect of the bioprocess. While bioprocesses may occur naturally in the environment, bioreactors allow for the development of an artificial environment with an optimum condition that allows the isolation and growth of particular cells or microbes. Background and Development on Bioreactors The term bioreactor can be used interchangeably with the term fermenter (Rasche, 2019). Researchers and scientists who cultivate yeast, bacteria, and fungi rely on fermenters, while those who cultivate mammalian cells often use bioreactors. Ferme...