by Leigh N. Pierce and Paul W. Shabram
Volume 3, Issue 4 (July/August 2004)
Single-use, disposable components offer many advantages in the manufacturing of biologics. They are clean and ready to use when supplied, which obviates the need for sterilization and decreases the requirement for services such as water for irrigation (WFI) systems and steam generators. Disposable components are not used for subsequent operations, eliminating the chance of cross contamination between process runs. Long lead times for equipment installation can be avoided because the need for stainless steel equipment is reduced or eliminated. Systems are less complex, therefore engineering requirements are also reduced. There is no need for clean-in-place (CIP) or steam-in-place (SIP) operations, along with the associated piping, valves, controls, or pressure rating of vessels. Moreover, the use of disposable components reduces the complexity of validation…
Citation:
Pierce LN, Shabram PW. Scalability of a Disposable Bioreactor from 25 L-500 L Run in Perfusion Mode with a CHO-Based Cell Line: A Tech Review. BioProcess J, 2004; 3(4): 51-56.