LePure Biotech offers top-mounted and bottom-mounted mixing systems. Top-mounted systems are primarily used for pilot-scale and small-volume solution preparation, with an open top design that facilitates observation and maintenance. Bottom-mounted systems mainly use magnetic coupling or magnetic levitation technology.
Magnetic coupling: An external magnetic rotor drives the impeller inside the bag without physical contact. The seal-less design eliminates the risk of mechanical seal leakage and is well suited to GMP manufacturing.
Magnetic levitation: Enables contact-free operation with zero friction and ultra-low shear.

LePure Biotech LeKrius^® single-use bioreactor bags are sterilized by gamma irradiation within a controlled dose range of 25–40 kGy. The upper limit of 40 kGy helps prevent film degradation caused by excessive irradiation, including oxidation or cross-linking, thereby protecting the product’s physicochemical properties and biological performance. The lower limit of 25 kGy ensures inactivation of the initial bioburden and achieves a sterility assurance level (SAL) of 10⁻⁶.

The standard operating temperature range for LePure Biotech LeKrius^® single-use bioreactor bags is 8–40°C. This temperature range is suitable for most mammalian cell culture processes, including CHO and HEK293 cells, and helps maintain film integrity without affecting cell viability. The maximum short-term temperature limit is 60°C. Brief exposure at this temperature, such as during certain treatment or process steps, will not compromise bag integrity; however, prolonged exposure at or above 60°C may degrade film performance.

Yes. LePure Biotech LeKrius^® single-use bags can be customized in terms of volume, bag configuration, inlet and outlet tubing, tubing length, connector type, sampling port, filter, aseptic connector, and sensor interface. Customization typically requires confirmation of the process fluid, working volume, temperature and pressure conditions, connection method, and aseptic handling requirements.