Meissner has expanded its One-Touch® single-use systems portfolio to include the Saltus® M200 Mixing system. Saltus® provides robust, reproducible, predictable mixing performance for biopharmaceutical manufacturing processes. Designed to incorporate Process Analytical Technology (PAT), while maximizing the benefits of a single-use mixing platform, Saltus® delivers on the promise of next generation single-use mixing.
Saltus® mixing systems are based on a design philosophy which emphasizes usability and automation. From the easy to install, self-deploying, single-use mixing assembly to the fully automated, one-button start of the control system, Saltus® mixers provide unparalleled usability and ease of operation.
Integrated advanced functionality is controlled through a single large format HMI. The Saltus® M200 features recipe storage, on screen production history, live data capture, advanced user settings and much more. Operation of the control system is protected by a three tiered permission level structure and the system generates non-corruptible batch records at the completion of any process. All process data and alarms are continuously monitored and saved to a local storage device located in a restricted access compartment within the mixer.
The gentle, yet highly effective mixing capability of Saltus® mixing systems is ideal for preparing solutions in a wide variety of applications such as hydration of cell culture media, buffer preparation, product reconstitution from concentrated solutions or powders, homogenization of dispersions or solutions, and chemical inactivation to affect viral clearance all under aseptic operating conditions. An extensive engineering analysis of the Saltus® M200 mixing system was performed using a Computational Fluid Dynamics (CFD) study. The resulting data demonstrates the mixer’s overall performance characteristics and mixing capabilities.
Meissner offers four standard single-use mixing biocontainer assembly configurations that are designed to accommodate both powder-liquid and liquid-liquid mixing. Additionally, Saltus® biocontainer assemblies can be customized to meet specific process requirements. Meissner’s proprietary fabrication process allows for a true centerline drain that provides optimized fluid recovery and up to three sample ports can be accommodated along the side of the single-use assembly. All single-use mixing assemblies are manufactured in an ISO 7 cleanroom environment and provided gamma irradiated at 25-40 kGy prior to delivery. Saltus® single-use mixing biocontainer assemblies are fully supported by an extensive qualification guide.