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LeKrius®Single-Use Mixing Bag

LeKrius®single-use mixing bag is an integrated solution developed by LePure Biotech for biopharmaceutical mixing processes, made from self-developed LDPE/EVOH/ULDPE three-layer co-extruded film material. It features ultra-low gas and water vapor permeability, outstanding mechanical strength, broad chemical compatibility, and fully compliant biocompatibility, eliminating the risk of contamination and leaching from the source.

Compatible with most mainstream magnetic mixing systems, the LeKrius®single-use mixing bag supports multiple mixing modes including magnetic/levitated magnetic, bottom/top-entry, and centered/eccentric mixing, as well as round/square vessel configurations. Available in closed or open designs, it suits both solid-liquid and liquid-liquid mixing applications. Customizable ports for temperature, pH and conductivity sensors enable in-line process monitoring. Broad working volume from 500 mL to 4,000 L with consistent scale-up performance ensures reliable preparation of process fluids across biopharmaceutical process.

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Description

Applications 

  • Upstream Cell Culture Process
  1. Efficient preparation and storage of media, feeds and buffers
  2. Homogenization and conditioning of cell harvest fluid
  • Downstream Purification Process
  1. Preparation of buffer, acid and base for purification workflows
  2. Process fluid regulation (pH, conductivity, etc.) and temporary holding
  • Formulation & Fill
  1. Precision mixing for drug substance dilution and volume fine-tuning
  2. Conditioning and temporary holding of formulation intermediates
  3. Mixing and temporary holding of fill-ready drug products
  • ADC Drugs, Plasmids & Gene Therapy Applications ·Preparation and mixing of ADC drug, plasmid and gene therapy-related process fluids

 

Features 

  • Manufactured by in-house developed and produced LeKrius® bioprocess film, DMF-filed, 400 μm reinforced, free of Irgafos™ 168, with low extractables and leachables, low particulates and endotoxins. The bag product series is fully compliant with USP, EP, ISO and ASTM standards
  • Raw materials and entire manufacturing process are TSE/BSE-free
  • Mixing Types: magnetic coupling, levitated magnetic mixing, top-mounted mixing, etc
  • Working Volume: 500 mL–4000 L; Sizes are fully customizable; Alternative filters, connectors, tubing and fittings are available
  • 100% integrity tested

 

Advantages 

  • Compatible with most mainstream mixing systems; no equipment modification required, reducing process modification costs. Flexible selection of tubing, fittings and other components, suited to customers’ existing consumable systems
  • Compatible with high‑salt and low‑pH process fluids, suitable for multi‑scenario applications
  • Full‑stage and full‑range compatibility (from R&D, pilot to commercial production stages), lowering operational costs
  • Modular design with diverse models adapts to different process complexities, streamlining the supply chain
  • Fully customizable bag body, feed ports, sensor ports, etc. to meet individual requirements precisely, with fast response and short lead times for custom orders
  • Local R&D and manufacturing with dual compliance and supply assurance, supporting long‑term stable production
  1. In‑house developed core film ensures a stable supply chain, consistent batch performance and reliable delivery. DMF‑filed film with complete compliance validation data supports global drug registration and mitigates compliance risks
  2. End‑to‑end technical support ensures stable process operation

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