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Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2020 37 that the BSC will perform properly, the responsi- bility for performance and cell culture protection ends with the buyer. Following design validation and performance verification at the manufactur- ing facility and periodically at the laboratory, the performance of the BSC and level of cell culture protection will largely depend on correct use by system operators. Operator competence is key Competent and knowledgeable BSC operators are critical to contamination control, because their actions directly inf luence airf low and the move- ment of contaminants. Taking an active approach to BSC operation, the operator should arrange for regular certification of the cabinet and ensure he or she has understood the test results—in partic- ular, those which might require that procedures be altered or improved (3). This active approach must be intertwined with various elements of ex- pertise, including the physical operation of the BSC machinery, interpretation of alarms, and an understanding of the controls, displays, and prin- ciples of operation. Often, problems with BSCs arise from incor- rect assumptions and poor practices. In some cases, staffers may not realize the consequences of actions, such as silencing an alarm, which can prevent understanding of risks, preventing iden- tification of any underlying root causes of po- tential contamination. Other examples of poor practices include failing to arrange materials op- timally within the BSC, and too many quick and unnecessary movement of hands and arms near the equipment, which call for limiting the num- ber of times users reach in and out of the BSC. Another frequent cause of problems is failing to wipe down the cabinet's interior surfaces before commencing work. Processes within the BSC should be optimized by a process designer together with an operator or technician that will be performing the required processes. The process designer must develop a clear understanding of what is needed for the laboratory's operations and procedures and create a detailed process workf low so that every operat- ing step has been optimized. Activities, equipment, and resources should be arranged so the workflow sequence can be followed consistently using aseptic best practices. Streamlining workf lows reduces the room for error and reliance on the operator's attention and should be used to examine every aspect of the pro- cess. For example, in the case of decontaminants, the process designer would consider the type, bot- tle size, and frequency of preparation required to meet lab needs. In the end, system efficacy is only as strong as its weakest link, and robust manufac- turing, validation, installation, and service infra- structure is the foundation required for effective laboratory contamination control. References 1. NSF, NSF/ANSI Biosafety Cabinetry Certification, nsf.org (2020). 2. C.K. Lincoln, M.G. Gabridge, Method Cell Biology 57, 49–65 (1998). 3. S. Horbach, W. Halffman, PLOS One, 12 (10) (2017). PT In the end, system efficacy is only as strong as its weakest link, and robust manufacturing, validation, installation, and service infrastructure is the foundation required.