Is there such a thing as a “universal solution” in the assessment of the technological options for the biotech industry? Do single-use process components outperform systems based on conventionally designed stainless steel equipment?
Whereas single-use technology has been an established practice in laboratories for many years, its application in biotech production is now being promoted heavily, particularly for cell culture. Vendors offer single-use components as part of a comprehensive tool box extending from simple storage and shipping bags to agitated tanks/bioreactors and tube manifolds and connectors. Even selected components for downstream processing steps are being marketed.
Single-use technology permits more cost-efficient design and swifter implementation compared to conventional stainless-steel components and allows bioprocessors to minimize technological and procedural cleaning efforts. Thus, preparation times are shortened, particularly for product changeovers, but also for batch-to-batch preparation during manufacturing.
Still, implementation time cannot be reduced at any level. Comprehensive planning is also required. Sourcing of basic process skids (bag support containers and control units) must be considered and is not negligible. Starting with mid-size installations, skids for generation and loops for distribution of clean utilities, namely WFI and clean steam, must also be designed, procured, and installed. Such systems are typically based on conventional stainless steel designs for fluid integrity and construction material handling reasons.