Diosna P1-6 Laboratory High-Shear Wet Granulator
| Brand | Diosna |
|---|---|
| Origin | Germany |
| Model | P1-6 |
| Maximum Batch Volume | 3 L |
| Temperature Range | < 100 °C |
| Particle Size Range | 100–500 µm |
| Sample Type | Organic |
| Compliance | GLP-aligned design, suitable for pharmaceutical development under ISO 22093 and ASTM E2500 guidance |
Overview
The Diosna P1-6 Laboratory High-Shear Wet Granulator is an engineered platform for scalable, reproducible wet granulation process development in early-stage pharmaceutical formulation, nutraceutical research, and fine chemical synthesis. Based on the Couette–Taylor flow principle, it integrates high-shear mixing and controlled mechanical densification within a sealed, jacketed cylindrical bowl. The unit operates via dual-agitator kinematics: a bottom-mounted impeller generates intense radial and axial shear to homogenize powder blends and binders, while a side-mounted chopper applies precise cutting forces to nucleate and size wet mass into dense, spherical granules. This architecture enables deterministic control over granule density, porosity, and surface morphology—critical parameters influencing downstream tableting performance, dissolution kinetics, and content uniformity. Designed for bench-scale feasibility studies, the P1-6 bridges the gap between formulation screening and pilot-scale process transfer, supporting QbD (Quality by Design) workflows per ICH Q5A–Q8(R2).
Key Features
- Modular bowl capacity options: standard 1.0–6.0 L volumes (3 L max working volume), with optional 0.5 L and 8.0 L configurations for extreme miniaturization or extended batch scalability
- Independent speed control of main impeller (0–1,200 rpm) and chopper (0–3,000 rpm), enabling independent optimization of mixing intensity and granule breakage kinetics
- Jacketed stainless-steel bowl with integrated PT100 temperature sensor port (optional), supporting real-time thermal monitoring during exothermic binder addition
- GLP-aligned operational log: timestamped parameter recording (speed, time, torque, temperature) via optional analog/digital interface
- Smooth, crevice-free interior surfaces (Ra ≤ 0.4 µm) compliant with ASME BPE-2022 hygienic design standards for easy cleaning and residue verification
- Interlocked safety door with position sensing and automatic motor cutoff; CE-marked per Machinery Directive 2006/42/EC and EMC Directive 2014/30/EU
Sample Compatibility & Compliance
The P1-6 accommodates organic powders including APIs, excipients (microcrystalline cellulose, lactose monohydrate, mannitol), polymers (HPMC, PVP), and botanical extracts. It supports aqueous and solvent-based binders (e.g., ethanol/water mixtures) under Class II containment conditions. The system meets foundational requirements for GMP-relevant lab environments: traceable calibration paths for torque and speed sensors, documentation-ready operation logs, and compatibility with FDA 21 CFR Part 11-compliant data acquisition systems when paired with validated third-party software. While not a production-grade GMP machine, its design conforms to ISO 22093:2021 (Good Manufacturing Practice for Pharmaceutical Equipment) Annex A for laboratory-scale equipment qualification.
Software & Data Management
The P1-6 operates in standalone mode with analog potentiometer controls or integrates with Diosna’s optional LabControl Suite—a Windows-based application supporting method storage, parameter sequencing, and real-time torque profiling. All runs generate CSV-exportable datasets containing time-stamped values for impeller speed, chopper speed, motor torque (Nm), elapsed time, and optional temperature (°C). Audit trails include operator ID, method version, and electronic signatures where linked to validated LIMS or ELN platforms. Raw data files are immutable post-acquisition, satisfying ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Applications
- Formulation development of immediate- and modified-release solid dosage forms
- Granule attribute mapping (density, friability, compressibility) versus binder concentration and shear time
- Process characterization for regulatory submissions (ICH Q5A, Q8)
- Feasibility testing of novel binders or low-dose API blends requiring high content uniformity
- Supporting DOE (Design of Experiments) for critical process parameter identification
- Training platform for manufacturing personnel prior to scale-up on Diosna production granulators (e.g., P1-30 or V-type series)
FAQ
Is the P1-6 suitable for handling heat-sensitive APIs?
Yes—its <100 °C operating limit, combined with optional temperature monitoring and short cycle times (dry mix: 2 min; wet granulation: 1–4 min), minimizes thermal exposure. Jacket cooling capability (with external chiller) further extends suitability for thermolabile compounds.
Can granule size distribution be predicted and controlled?
Within defined operational boundaries, yes. Particle size (100–500 µm) correlates strongly with chopper speed, binder addition rate, and impeller tip speed. Empirical models derived from P1-6 data have demonstrated R² > 0.92 for Dv50 prediction across multiple formulations.
Does Diosna provide IQ/OQ documentation templates?
Yes—Diosna supplies vendor-verified Installation Qualification (IQ) and Operational Qualification (OQ) protocols aligned with ASTM E2500-13, including test scripts for speed accuracy, torque linearity, temperature sensor calibration, and safety interlock verification.
Is the system compatible with nitrogen inerting?
The bowl lid includes a dedicated gas inlet/outlet port (¼” NPT) and pressure relief valve, enabling integration with nitrogen purge systems for oxygen-sensitive or pyrophoric materials.
What maintenance intervals are recommended?
Daily visual inspection of seals and bowl gasket; monthly lubrication of chopper shaft bearings (per DIN 51502 KP2K-20); annual recalibration of torque sensor and speed encoders by authorized Diosna service engineers.
