ABSTRACT
The processing systems for cell and tissue cultures suitable for therapeutic application are promising devices to save labor tasks, space, and contamination risk. Similar to the isolator system in the aseptic processing of healthcare products based on pharmaceutical regulation, the installation of a decontamination apparatus into the processing system will realize a further reduction in manufacturing costs based on the proposed siting criterion in an ISO Class 8 clean area without any increment of contamination risk. Furthermore, flexible modular platform (fMP) technology will realize the flexible combination of isolator modules, the practical design for cell sheet assembling was successfully performed. These proposals of the siting criterion and manufacturing system for the isolator and fMP technologies are expected to enhance process versatility accompanied by safety, security and cost-saving.
