Caleva MBS-250 Laboratory Extrusion-Spheronization System

Overview

The Caleva MBS-250 is a benchtop extrusion-spheronization system engineered for precise, scalable, and reproducible production of spherical granules from wet mass—primarily used in pharmaceutical solid dosage form development, including immediate- and controlled-release tablets, as well as advanced applications in functional food, catalyst support, and specialty polymer microspheres. Unlike conventional spheronizers relying solely on centrifugal force, the MBS-250 integrates a modular extruder (sold separately or as part of the MBS Extruder-Spheronizer Package) with a rotating friction-based spheronization chamber. This dual-stage process—extrusion followed by controlled tumbling and attrition in a rotating bowl—enables robust particle rounding via plastic deformation and surface coalescence under defined shear and residence time conditions. The system operates on the principle of rheological conditioning: wet mass is first extruded into cylindrical strands, then cut to uniform lengths before being fed into the spheronizer bowl, where rotational motion, bowl geometry, and dwell time govern sphericity, size distribution, and surface smoothness.

Key Features

• Modular bowl diameter options: 250 mm (standard), 120 mm, 85 mm, and 60 mm—each optimized for distinct batch scales (600 g, 130 g, 15 g, and 5 g typical max loads respectively)
• Interchangeable bowl inserts (85 mm and 60 mm) fabricated from either FDA-compliant polymeric materials or electropolished 316 stainless steel for GMP-compliant processing
• Radial-patterned bowl base (standard) and optional PTFE-coated bowls to minimize adhesion and facilitate cleaning validation
• Integrated safety interlock system: automatic motor shutdown upon lid disengagement or door opening, compliant with IEC 61000-6-2/6-4 and EN 60204-1
• Optional jacketed bowls (for 120 mm and 250 mm configurations) enabling temperature-controlled spheronization (e.g., for thermosensitive APIs or waxy binders)
• Configurable timer-based automation and optional DataStor™ data acquisition module for real-time logging of rotational speed, bowl temperature, and runtime—supporting 21 CFR Part 11–compliant audit trails when paired with validated software
• Full IQ/OQ documentation package available, aligned with ASTM E2500-23 and ISPE GAMP® 5 guidance for laboratory-scale equipment qualification

Sample Compatibility & Compliance

The MBS-250 accommodates a broad spectrum of formulation types—including aqueous, alcoholic, and solvent-based wet masses—with viscosity ranges typical of pharmaceutical extrudates (10–500 Pa·s at 10 s⁻¹ shear rate). It supports both high-shear and low-moisture formulations, and its adjustable rotational speed (typically 200–1,200 rpm) and dwell time (1–20 min) allow empirical optimization across binder systems (e.g., HPMC, PVP, MCC, starch derivatives). All contact surfaces meet USP material classification requirements; FDA-compliant polymer bowls are certified per USP Class VI biocompatibility testing. The system is routinely deployed in GLP- and GMP-regulated environments for preformulation screening, formulation robustness studies, and clinical batch manufacturing (Phases I–III), and complies with ISO 9001:2015 quality management system requirements for instrument suppliers.

Software & Data Management

While the base MBS-250 operates via manual control panel, the optional DataStor™ interface connects to a Windows-based host PC via USB or RS-232, capturing timestamped operational parameters at user-defined intervals (down to 1-second resolution). Raw data exports to CSV format for integration with LIMS or statistical analysis platforms (e.g., JMP, Minitab). When deployed under validated conditions, the DataStor™ system supports electronic signatures, user access levels, and change control logs—meeting ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) for regulated data integrity. Audit trail functionality satisfies FDA 21 CFR Part 11 Subpart B requirements for electronic records and signatures.

Applications

• Pharmaceutical development: Screening of spheronization behavior across binder type, concentration, and moisture content
• Clinical trial material production: Generation of 100–600 g GMP-grade microspheres per batch for Phase I–II oral dosage forms
• Process transfer studies: Bridging lab-scale (MBS-250) to pilot-scale (Caleva TSE-12 or industrial spheronizers) using geometrically similar bowl dynamics
• Material science research: Fabrication of ceramic precursors, catalytic pellets, and polymer microbeads with narrow Dv50–Dv90 distributions
• Regulatory filing support: Generating comparative data for ANDA or NDA submissions, including particle morphology imaging (via optional integrated camera port) and friability correlation studies

FAQ

Is the MBS-250 compatible with existing Caleva extruders?
Yes—the MBS-250 is fully interoperable with Caleva’s TSE-10, TSE-12, and V5 extruder models via standardized feed chutes and alignment fixtures.
Can the system be qualified for GMP manufacturing?
Yes—Caleva provides IQ/OQ protocols and templates; PQ execution requires site-specific process parameters and is typically performed by the end user or qualified third-party service provider.
What maintenance is required for long-term reliability?
Routine inspection of bowl drive coupling, belt tension, and bearing lubrication every 500 operating hours; full preventive maintenance recommended annually per Caleva Service Bulletin SB-MBS-250-Rev.4.
Does the MBS-250 support continuous operation mode?
No—it is designed exclusively for discrete batch processing; continuous spheronization requires dedicated inline systems not offered within the MBS platform.
Are replacement bowls and tooling available globally?
Yes—all bowl sizes, radial bases, PTFE coatings, and jacketed assemblies are stocked by Caleva’s UK headquarters and distributed through authorized partners in North America, EMEA, and APAC regions.