Pharmatech MB005 Laboratory Drum-Type Powder and Granule Blender
| Origin | UK |
|---|---|
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | MB005 |
| Pricing | Upon Request |
Overview
The Pharmatech MB005 Laboratory Drum-Type Powder and Granule Blender is an engineered solution for precise, reproducible, and GMP-compliant dry blending of pharmaceutical powders, granules, excipients, and functional food or cosmetic formulations. Based on the principle of tumbling motion within a rotating containment vessel—commonly referred to as “drum blending” or “tumble blending”—the MB005 achieves homogeneity through gravitational cascading and gentle axial rotation, minimizing particle attrition and segregation. Unlike high-shear mixers, this system operates without internal agitators, preserving delicate particle morphology and flow properties essential during early-stage formulation development and clinical batch manufacturing. Designed in accordance with ICH Q5A, ISO 14644-1 (cleanroom compatibility), and EU Annex 1 requirements, the MB005 serves as a critical unit operation in process validation, blend uniformity studies (per USP ), and scale-up bridging from lab to pilot production.
Key Features
- Fully stainless steel (304 SS) construction with brushed surface finish, electropolished welds, and IP65-rated enclosure for washdown compliance and corrosion resistance.
- Adjustable rotational speed range of 5–30 rpm, optimized for low-shear blending kinetics while maintaining consistent torque output (5 N·m).
- Tool-free, rapid料斗 interchange system enabling seamless switching between interchangeable drum geometries—including V-cone, double-cone, cylindrical (25° tilt), IBC-style square-cone, and custom-profile vessels—within seconds.
- Integrated 5.7-inch color HMI touchscreen interface with intuitive menu navigation, real-time status monitoring, parameter logging, and configurable alarm thresholds.
- Interlocked safety door with mechanical and electronic redundancy ensures automatic motor shutdown upon lid opening—fully compliant with EN/IEC 60204-1 and Machinery Directive 2006/42/EC.
- Vertical auto-stop function prevents uncontrolled rotation post-cycle, enhancing operator safety and sample integrity.
- Modular mobility design: compatible with optional 304 SS mobile carts featuring integrated storage compartments for spare drums and accessories.
Sample Compatibility & Compliance
The MB005 accommodates batch volumes from 0.1 L to 5 L (maximum fill volume: 3.3 L at bulk density 1.0 g/mL), supporting both free-flowing and cohesive materials across API-excipient blends, coated granules, micronized actives, and multi-component nutraceutical powders. All wetted surfaces meet ASME BPE-2022 surface finish standards (Ra ≤ 0.8 µm). The blender is certified CE-marked and designed to support full GxP compliance workflows—including traceable batch records via thermal printer (25-year archival paper stability), audit-ready electronic logs, and optional 21 CFR Part 11–compliant PLC control architecture with electronic signatures and change management protocols. Validation documentation packages (DQ/IQ/OQ/FAT) are available upon request for regulated environments.
Software & Data Management
Standard HMI firmware supports user-defined recipe storage (up to 100 profiles), time-stamped cycle logging (start/stop time, speed, duration), and error-code diagnostics. Optional PLC integration enables centralized SCADA connectivity, S88/S95 batch record generation, and automated data export to LIMS or MES platforms. Thermal printer output includes operator ID, timestamp, setpoints, actual runtime, and pass/fail flags against predefined acceptance criteria—supporting ALCOA+ data integrity principles. For advanced analytics, Pharmatech offers optional BlendView NIR modules (BV-series), though not included in base MB005 configuration; these provide real-time spectral acquisition and endpoint determination using chemometric modeling.
Applications
- Pre-formulation screening and dose proportionality studies.
- Blend uniformity qualification per USP and Ph. Eur. 2.9.30.
- GMP-compliant clinical trial material (CTM) production (Phase I–II).
- Excipient compatibility testing and stability-indicating blend studies.
- Process characterization for Quality-by-Design (QbD) initiatives.
- Scale-down modeling for commercial twin-shell or V-blender qualification.
- Cleanability verification and residue limit assessment protocols.
FAQ
Is the MB005 suitable for potent compound handling?
Yes—when equipped with ATEX-certified options (Zone 21/22) and sealed drum interfaces, it supports OEL-based containment strategies for HPAPIs.
Can the MB005 be validated under FDA or EMA guidelines?
Absolutely—the system is supplied with FAT documentation and supports full DQ/IQ/OQ execution; IQ/OQ protocols aligned with ASTM E2500 and ISPE Baseline Guide v11 are available.
What power supply configurations are supported?
Standard configuration is 230 V / 50 Hz; non-standard voltages (e.g., 115 V / 60 Hz, 400 V / 50 Hz) are available as factory-configured options.
Does the MB005 require compressed air or external utilities?
No—it operates solely on single-phase electrical supply; no pneumatics, cooling water, or exhaust ducting is required.
How is cleaning verified between batches?
The smooth, crevice-free stainless-steel housing and quick-release drum mount facilitate visual inspection and swab sampling per PDA TR29; CIP compatibility is achievable with optional spray ball integration.
