Problem
A key consideration for the optimal design and operation of a bioprocess manufacturing facility has been controlling the environment to ensure the quality and safety of the products. These controls are specifically developed to ensure that cGMP regulatory requirements are followed during commercial biopharmaceutical manufacturing processes. The cleanrooms are not just expensive but difficult to maintain and operate as all the materials need to be cleanroom classified. Many controls are involved to ensure cleanliness like having an epoxy coating on the surfaces, temperature control, pressure controls, and airflow controls.
To envision bioprocess manufacturing outside a controlled environment is difficult but not impossible. Technological advances have continuously reduced the risk of environmental impact on the process stream. Compared to manufacturing conducted in an open environment, which increases the requirement for strict environmental controls, adopting an alternative approach of using a functionally closed processing environmental setup can decrease dependence on such stringent rules. The process stream is isolated from the environment in a closed or functionally closed system. Such designs should be used wherever possible to shift towards a manufacturing system that isn't tightly controlled.