Posted on: 27th November 2017
The Drug Substance Phorum’s Closed Systems workstream is almost ready to publish its scientific report into alternative methods to functionally close low bioburden API processing systems.
Workstream member Dr Kavita Ramalingam Iyer, MSD, presented the final results of the study at the BPI annual meeting in September and had an interview with Anne Montgomery, Editor In Chief, BioProcess International Magazine.
Click here to watch the video and find out more about the study and the conribution of BPOG’s Regulatory Interaction team:
The study seeks to demonstrate that operating a functionally closed system in a CNC environment is equal to or better than operating an open process in a grade C environment, for bioburden controlled processes. This has significant advantages in both capital and operational costs, and facilitates operating a multi-product ballroom.
This complex project has been run in collaboration with the Biomanufacturing Training and Education Center (BTEC) at the NC State University. It has generated data that shows cleaning operations; flushing with process water or de-soiling agents; post system assembly can successfully render a temporary opening in a bioprocessing system functionally closed. In some instances, a six log reduction in bioburden was achieved. Rending this as a viable alternative method to, steaming systems, or managing open connections by operating in a grade C environment.