Diosna P/VAC 10–60 Laboratory-Scale High-Shear Wet Granulator

Overview

The Diosna P/VAC 10–60 is a modular, high-shear wet granulator engineered for laboratory and pilot-scale pharmaceutical process development. It operates on the principle of controlled mechanical energy input—via a rotating main impeller and a high-speed chopper—to induce nucleation, coalescence, and consolidation of powder blends in the presence of a liquid binder. Its dual-function architecture supports both aqueous or solvent-based wet granulation and subsequent in-situ vacuum drying within the same vessel, eliminating intermediate transfer steps and minimizing contamination risk. Designed as a scalable representation of Diosna’s production-grade P/VAC series, the unit maintains geometric and dynamic similarity—including impeller tip speed, power input per unit volume, and shear rate distribution—enabling reliable data extrapolation to commercial-scale manufacturing (e.g., P/VAC 250–2000). The system complies with core design principles outlined in ICH Q5A(R2), Q8(R2), and FDA Process Validation Guidance, supporting Quality-by-Design (QbD) workflows in early-phase clinical batch production.

Key Features

• Modular, interchangeable granulation vessels (10 L, 25 L, 60 L) and vacuum drying vessels (20 L, 50 L), enabling rapid process screening across formulation and scale-up studies.
• Integrated vacuum drying capability with cylindrical vessel geometry, gas-scouring nozzles, and pneumatically actuated lid—designed to ensure uniform moisture removal while preserving granule integrity.
• Main impeller equipped with an integrated scraper extension at the blade tip, actively preventing wall buildup during high-viscosity processing—mirroring the anti-adhesion functionality of full-scale Diosna processors.
• Center-shaft pneumatic sealing system compliant with WIP (Wash-in-Place) protocols; accommodates multiple seal configurations (e.g., double mechanical seals with barrier fluid) for GMP-aligned cleaning validation.
• Full PLC-based control via an operator terminal with configurable recipe management, real-time trend logging, and audit-trail-enabled parameter recording per 21 CFR Part 11 requirements.
• Optional real-time monitoring of granulation endpoint via motor current draw and power consumption profiling—correlating electrical load signatures with granule growth kinetics and density transitions.

Sample Compatibility & Compliance

The P/VAC 10–60 accommodates a broad range of active pharmaceutical ingredients (APIs), excipients (e.g., microcrystalline cellulose, lactose monohydrate, crospovidone), and binders (e.g., PVP K30, HPMC, hydroalcoholic solutions). Its stainless-steel 316L contact surfaces meet ASTM A276 and EN 10088-1 standards. Vessel geometries and impeller designs conform to ISO 14644-1 Class 7 cleanroom compatibility when installed with appropriate HVAC integration. The system supports qualification documentation packages aligned with EU Annex 15 and USP , including IQ/OQ/PQ protocols. All control software modules are validated for use in regulated environments under GxP frameworks, with electronic signature support and user-access-level controls.

Software & Data Management

The embedded Siemens SIMATIC S7-1200 PLC interfaces with a 10.1″ touchscreen HMI running TIA Portal v18. Process parameters—including impeller speed, chopper speed, torque, temperature, vacuum level, and elapsed time—are logged at ≥1 Hz resolution. Historical data export is supported in CSV and PDF formats with timestamped metadata. Optional integration with MES platforms (e.g., Siemens Opcenter Execution) enables batch record synchronization and electronic batch reporting (EBR). Audit trails capture all parameter changes, user logins, and recipe modifications with immutable timestamps, satisfying FDA 21 CFR Part 11 and EU Annex 11 data integrity requirements.

Applications

• Clinical trial material (CTM) production for Phase I–III batches under cGMP-compliant conditions.
• Formulation feasibility assessment—including binder selection, liquid addition rate optimization, and endpoint determination via torque or power profiling.
• Process characterization studies supporting Design Space definition per ICH Q8(R2).
• Drying kinetics evaluation under reduced pressure for thermolabile compounds or low-boiling solvents.
• Scale-down modeling for tech transfer to commercial Diosna P/VAC systems, leveraging consistent Froude and Reynolds number scaling relationships.
• Training platform for operators transitioning from lab to production environments—featuring identical HMI layout, alarm logic, and interlock behavior.

FAQ

Can the P/VAC 10–60 be used for both high-shear granulation and fluid-bed drying?
No—fluid-bed drying requires separate equipment. The P/VAC 10–60 performs vacuum-assisted drying only, using conductive heating and pressure reduction within the sealed granulation vessel.
Is the system suitable for handling potent compounds?
Yes—when configured with containment options such as split butterfly valves, glove ports, and integrated dust extraction, it meets OEL ≤10 µg/m³ requirements per ISPE Guide: Containment.
Does the unit support automated cleaning validation?
Yes—the WIP-capable center-shaft seal and fully drainable vessel geometry enable repeatable cleaning cycles; residue sampling points and conductivity monitoring ports are available as factory options.
What documentation is provided for regulatory submissions?
Diosna supplies a complete qualification dossier (IQ/OQ templates, FAT/SAT reports), material traceability certificates, and 21 CFR Part 11 compliance statements upon request.
How is scalability assured between P/VAC 10–60 and production-scale units?
Through maintained dimensionless numbers (e.g., constant impeller tip speed, power/volume ratio, and Froude number), validated by Diosna’s Scale-Up Engineering Group using proprietary CFD and DEM simulation models.