Reference no: EM133281665

1) It is obvious that bioprocess control involves more than just automation and considers factors like environmental monitoring and room cleanings. In addition, concepts of HEPA filtration and facility design concepts all of which are compiled and optimized according to demand. However, because of the non-linearity, variability, and complexity of biotech processes, bioprocess control can address specific problems that develop various area classifications which is the backbone of the biomanufacturing operations. Bioprocess manufacturing execute various operation to keep the environment according to demand such as, regulate temperature and humidity controls, a positive pressure air supply that is filtered using high-efficiency particulate air filters, whether the flow is laminar or not, a method for sanitizing the space in all aspect, and the tools to create a aseptic environment and procedure for keeping up any machinery used to regulate aseptic conditions. In addition, since most of the contaminant came from the personnel who works in the bioprocess facility, enter the room must also comply the aseptic gowning demand.

2) To mitigate the extensive requirements of manufacturing in a cleanroom, other ideas have been considered in the pharmaceutical industry. One idea proposed by Cytiva is the utilization of closed systems in a large open area called the "Ballroom" concept (Cytiva, 2020). The idea is that each part of the manufacturing process would be carried out in a completely closed system that is mobile. Since the system would be completely closed off to the surrounding environment, the idea is that the outside environment would not need to be controlled. In addition to this, the plan would allow for easy scale up since additional units can be added to the line for increased production, and there would be flexibility in space requirements. This proposed idea would allow for a significantly cheaper cost of facilities since it is just a closed container that needs to be controlled rather than an entire room. Additionally, as biomanufacturing becomes even more targeted towards patients an there are unique specs for many different product lines, this ballroom approach would allow for easy transition and manipulation of the manufacturing process.