Mustang® XT5000 Membrane Chromatography Systems

Mustang® XT5000 Membrane Chromatography Systems

Pall Life Sciences Products - Biopharmaceutical Division

High throughput and fast processing in capsule format Mustang® XT5000 capsules provide the benefits of membrane chromatography in a convenient large-scale capsule format for single use processing. ...read more

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Description

 

High throughput and fast processing in capsule format
Mustang® XT5000 capsules provide the benefits of membrane chromatography in a convenient large-scale capsule format for single use processing. Each unit is constructed with Pall's proven Mustang multi-layer membrane format with an equivalent membrane volume of 5 liters per capsule. Systems may be designed and operated with capsules in series or parallel for even greater processing capacities where required. This is an ideal format for many applications of ion exchange chromatography in biopharmaceutical and bioprocessing applications.

Capsule Format

Mustang Q capsules are more convenient, more reliable, and quicker to use than chromatography resins because they are provided in a format which does not require any media packing. They also are designed for single batch use, thereby eliminating cleaning and the time and cost associated with cleaning validation. Cross contamination risks are also removed with single batch processing. Multiple cycle batch processing is also possible due to the high flow rates and short cycle times, which may be used with these capsules.

Features and Benefits
• Binding Efficiency — Negatively-charged biomolecules are readily bound in a single pass.
• Speed — High-flow rates enable the processing of large volumes in less than a single working shift. Mustang XT 5000 capsules typically operate at 10 membrane volumes/min flow rates (50 L/min) making membrane chromatography 30 to 50 times faster than a conventional chromatography resin. • Scalability — A full range of sizes accommodates the different volumes and capacities required in BioPharmaceutical processing.
• Reproducibility — Six sigma statistical process control system in place to ensure reproducible process and conformance to specifications, enabling consistent process performance.
• Convenience — Ready to use, disposable to eliminate packing, cleaning, cleaning validation and cross-contamination issues.
• Cost — Lower operating costs and capital investment compared to conventional columns that need validated packing and cleaning protocols.

High Quality Standards
• Manufactured to high quality assurance standards in accordance with ISO 9000
• Membrane lots tested for dynamic protein binding capacity using standard biomolecules
• Identified by lot number and a unique serial number for complete traceability of manufacturing history, satisfying stringent QC/QA requirements
• Supplied with Certificate of Analysis to confirm the quality and quality control of Pall
• Meets USP Biological reactivity tests in vivo in accordance with USP Class VI 50 ºC and all materials listed in Drug Master File submitted to the FDA.

Comprehensive Validation

• Extensive validation performed to ensure consistent and reliable performance
• A comprehensive validation guide is available

Chromatography Performance

In most applications the dynamic binding capacity of Mustang Q membrane is equivalent or greater than the equivalent resin chemistries. In polishing applications, for removal of low levels of contaminants this means the high flow rates (more than 10 cv/min) and low pressure drops can be fully exploited with minimum membrane volume. In capture applications, good resolution with high yields and minimal elution volumes are achieved, due also to the characteristics of the membrane, the uniform flow path and the very low total volume to membrane volume ratio which is engineered into the XT capsule.

Modular Capacity Increases and Systems
The low pressure drop and the low dead volume of the XT capules means that systems may be configured with multiple units for even higher throughput per cycle in large volume applications with scaleable performance. Installation space is low due to the packing density of the membrane in the capsule and the ability to stack capsules. Each unit is approximately 15 kg (30 lbs) saturated weight and is fitted with 1.5" standard sanitary inlet and outlet connections for easy assembly and disassembly. A stacking support stand is available as a standard option. Chromatography systems can also be supplied as customized or standard engineered packages complete with pump and process instrumentation.

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