Today, nearly 97% of biopharmaceutical manufacturers use single-use technologies.1 Not only are manufacturers implementing single-use technologies, but also the range of applications for which these technologies are being used is expanding. Single-use technologies are now being implemented for critical steps involving direct product contact. This gives new importance to the way these technologies are selected, implemented, and used. Issues of qualification, validation, and sterilization have greater implication when entire product batches are at stake.
Q Where are single-use technologies currently being used in biopharmaceutical processing?A Single-use technologies have traditionally been used for small-scale buffer filtration, media preparation, and storage. Recent innovations have made a wider range of single-use technologies available for most downstream purification applications and production scales. These include mixing technologies, cell culture bioreactors, membrane and column chromatography, tangential flow filtration systems, and formulation and filling technologies.
Q What are the limits in scale of operation?
A Single-use technologies are now common in full-scale production operations, and range in size from just a few milliliters to several thousand liters. Disposable bioprocess bags can accommodate up to approximately 3,000 L of fluid and disposable bioreactors have been used for production purposes up to 500 L of cell culture.
Q What are the limits of operating pressure and temperature associated with single-use systems?
A Single-use systems can withstand comparatively less pressure than stainless steel systems. However, exact limits depend on the material composition of the system and the tubing attachment method. In general, bioprocess bags and tubing cannot withstand more than a few psi (<0.5 bar) of pressure. However, tubing can be reinforced to withstand greater pressures. Most capsule filters can be used with up to 45 psi (3 bar) pressure and a limited few can withstand up to 90 psi (6.5 bar) pressure.
Biopharmaceutical manufacturers also must consider the temperature limits of single-use technologies when selecting new components and systems. Disposable components are generally suitable for standard biopharmaceutical operating temperatures, which range between 4 and 40 °C. However, some bags, tubing, and connectors may not meet low temperature requirements for storage. Most biopharmaceutical drugs are stored at –30 °C but some products (e.g., cells) require storage at –80 °C. It is critical that biopharmaceutical manufacturers validate all components in the assembly to ensure that they meet the complete range of temperature requirements. Although stainless steel systems have no temperature limitations, integral parts such as seals often do, and therefore must be validated to temperature specifications.