Single-Use Mixing Systems
NewMix®-LevTech® Single-Use Mixing Systems from ATMI LifeSciences is comprised of the broadest range of technology focused on mixing in single-use bags for biopharmaceutical production. The NewMix-LevTech product line includes ATMI’s Jet-Drive™, LevMixer®, Magnetic Mixer, Pad-Drive™, and WandMixer®. All five hardware platforms interface with ATMI LifeScience’s in-house extruded TK8 film developed specifically for the Bioprocess industry.
ATMI comes to the Life Sciences industry via the Semiconductor industry with expertise in delivering process efficiency to a cost-driven high standards market. Our NewMix-LevTech single-use mixing products are developed to fulfill the Bioprocess industry’s appetite for flexible, fast, effective, and efficient disposable mixing solutions geared to maximize product yield and integrity.
Benefits
• Faster development and production cycles
• Quicker time to market
• Rapid process changeover
• Ensure materials integrity across “multi-product” manufacturing facilities
• Increased throughput and improved facility utilization
• Reduced capital investment
• Higher return on investment capital
NewMix-LevTech single-use mixers range in scale from 5 liter bench-top systems to 2000 liter floor-based systems. Many of the disposable mixing bag containers are compatible with floor scales or load cells and all containers are available jacketed or non-jacketed to facilitate various process temperature requirements. ATMI single-use mixers are poised for a variety of settings and applications from product development and buffer preparation to cGMP manufacturing and final formulation.
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All of ATMI’s mixing systems utilize single-use mixing bags from our in-house extruded TK8 film. The product-contacting layer of TK8 is blow extruded in-house by ATMI under cleanroom conditions using medical-grade ultra low-density polyethylene resin, then laminated to create a gas barrier film of exceptional cleanliness, strength, and clarity that is animal derived component free (ADCF) and complies fully with USP Class VI requirements. ATMI maintains an extensive dossier of supporting documentation to facilitate implementation of TK8 film by our customers. One such document is the TK8 Validation Binder, a collection of film characterization data, compliance certificates and test results intended to provide much of the baseline information required to support the use of TK8 film in biopharmaceutical manufacturing processes.
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