LePure Biotech LePhinix^™ single-use bioreactors are available in sizes from 50 to 2,000 L and are widely used in commercial manufacturing. For example, in a 2,000 L CHO cell culture process, viable cell density can exceed 2 × 10⁷ cells/mL, enabling a single batch to support the commercial produciton of most monoclonal antibodies, vaccines, and other biologics.

No. LeKrius^® Bioprocess film does not contain Irgafos^™ 168. Its raw-material composition and potential extractables and leachables risks are controlled by design. For specific products, process fluids, or long-term storage applications, an assessment should be performed using the relevant product validation documents and the customer’s process conditions.

LeKrius^® film is a multilayer co-extruded film developed by LePure Biotech for single-use bags and fluid-handling systems. It consists of LDPE, EVOH, and ULDPE layers and has a thickness of 400 μm. The film provides heat-sealing performance, gas-barrier properties, puncture resistance, and flex-crack resistance, making it suitable for the storage, preparation, and transfer of cell culture media, buffers, and a wide range of biopharmaceutical process solutions.

The LePure Biotech LePurweld^™ fully automatic aseptic tube welder features real-time temperature monitoring to maintain consistent welding energy and prevent cold or incomplete welds. Its welding head is designed for easy removal, facilitating routine cleaning and visual inspection. Process parameters can also be locked to prevent unauthorized changes.

The LePure Biotech LePurseal^™ fully automatic aseptic tube sealer offers broad compatibility and operational flexibility. It supports thermoplastic elastomer (TPE) tubing with outer diameters from 1/4 to 1 inch (approximately 6.35–25.4 mm) and can aseptically seal and disconnect dry, wetted, or fluid-filled tubing at different process steps.