ProCepT Mi-Pro Micro Granulator
| Brand | PROCEPT |
|---|---|
| Origin | Belgium |
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | Mi-Pro |
| Price Range | USD 55,000 – 68,000 |
| Batch Capacity | 100–700 g |
| Vessel Volume | 1 L (for 100–200 g) or 4 L (for 400–700 g) |
| Impeller Speed & Torque | 50–1350 rpm, up to 6000 mN·m |
| Chopper Speed | 500–5000 rpm |
Overview
The ProCepT Mi-Pro Micro Granulator is a precision-engineered laboratory-scale granulation system designed for development-stage formulation scientists working in pharmaceutical R&D, CMC, and early-phase clinical manufacturing. It operates on the principle of high-shear wet granulation, melt granulation, and melt coating—enabling reproducible particle engineering across multiple unit operations within a single, modular platform. Unlike conventional benchtop granulators, the Mi-Pro integrates real-time torque monitoring, programmable impeller/chopper speed coupling, and thermally controlled vessel jackets to support both aqueous and solvent-free processing pathways. Its compact footprint and glovebox-compatible mechanical interface make it uniquely suited for handling highly potent active pharmaceutical ingredients (HPAPIs), cytotoxic compounds, and controlled-substance formulations under ISO Class 5 or Grade A containment environments.
Key Features
- Modular dual-vessel configuration: Interchangeable 1 L (low-volume, high-precision) and 4 L (scale-up representative) vessels—each equipped with integrated temperature-controlled jackets for active cooling (−10 °C to +40 °C) during melt granulation cycles.
- Independent dual-speed actuation: Programmable impeller (50–1350 rpm, max torque 6000 mN·m) and chopper (500–5000 rpm) drives enable precise control over granule nucleation, consolidation, and densification kinetics.
- Standard dual-stream atomizing nozzle: Delivers uniform liquid distribution via coaxial fluid paths—optimized for binder solution spraying in wet granulation and for molten polymer dispersion in melt coating applications.
- Glovebox-integrated mechanical design: All process-contact surfaces (vessel, impeller, chopper, nozzle mount) are accessible via ISO-KF or CF flanged interfaces; no external cabling or pneumatic lines penetrate the containment boundary.
- Single-use component option: Disposable stainless-steel–lined polymer vessels, impellers, and nozzles available with pre-sterilized packaging—fully compliant with ICH Q5A and ISPE PPC Annex 1 risk-based containment requirements.
Sample Compatibility & Compliance
The Mi-Pro accommodates a broad spectrum of formulation matrices—including low-dose APIs (<1 mg/g), high-viscosity binders (e.g., HPMC, PVP K30), thermolabile polymers (e.g., Eudragit® E PO), and waxy excipients (e.g., Compritol® 888 ATO). Its design conforms to key regulatory expectations for developmental equipment: mechanical calibration traceability per ISO/IEC 17025, documentation of material-of-construction compliance (ASTM F899 316L SS, USP Class VI elastomers), and full audit trail capability when paired with optional 21 CFR Part 11-compliant software modules. The system supports GLP-aligned operation through configurable electronic batch records and user-access-level permissions.
Software & Data Management
The Mi-Pro is operated via the ProCepT Control Suite v3.2—a Windows-based application supporting protocol-driven execution, real-time torque/temperature/speed trending, and automated endpoint detection (e.g., power consumption inflection point for granule growth cessation). All raw sensor data (100 Hz sampling), method parameters, operator IDs, and timestamped event logs are stored in encrypted SQLite databases with SHA-256 hashing. Optional integration with LIMS or MES platforms is supported via OPC UA and ASTM E2500-15-compliant data export templates (CSV, XML, PDF eBR).
Applications
- Early-stage formulation screening of wet granulation process parameters (binder addition rate, impeller speed ramping profiles, chopper dwell time).
- Development of melt-granulated immediate-release tablets using lipid-based matrices without organic solvents.
- Feasibility studies for hot-melt coating of mini-tablets or extruded pellets using thermoplastic polymers.
- Process characterization for QbD implementation—supporting DOE-based identification of critical process parameters (CPPs) linked to CQAs such as granule size distribution (D10/D50/D90), bulk/tapped density, and tablet tensile strength.
- Support of regulatory filings: Data generated on the Mi-Pro has been cited in multiple Type II DMFs and FDA IND submissions for HPAPI-containing oral solid dosage forms.
FAQ
Is the Mi-Pro suitable for GMP manufacturing?
The Mi-Pro is intended for non-commercial development use only; however, its design basis, documentation structure, and qualification protocols align with Annex 15 and ASTM E2500-15 for equipment used in GMP-regulated environments.
Can I validate the torque measurement system?
Yes—torque transducers are factory-calibrated against NIST-traceable standards and include a Certificate of Calibration valid for 12 months; on-site verification kits are available upon request.
What materials contact the product during processing?
All wetted parts are constructed from electropolished ASTM F899 316L stainless steel; seals utilize USP Class VI-certified fluorosilicone or EPDM compounds depending on thermal and chemical exposure requirements.
Does the system support remote monitoring?
Remote desktop access and live telemetry streaming (via secure TLS 1.2 tunnel) are enabled when deployed behind corporate firewalls with appropriate network segmentation policies.
Are IQ/OQ protocols provided?
Comprehensive vendor-supplied IQ/OQ documentation packages—including test scripts, acceptance criteria, and blank execution records—are delivered with each system and fully editable for site-specific adaptation.
