Glatt VG10 High-Shear Wet Granulator

Overview

The Glatt VG10 is a laboratory-scale high-shear wet granulator engineered for precise, reproducible granulation process development and formulation optimization under GMP-aligned conditions. Based on the proven Glatt conical bowl design, it operates on the principle of simultaneous mechanical agitation and high-speed chopper action to induce nucleation, growth, and densification of powder particles in the presence of a liquid binder. The unit delivers controlled shear stress distribution across the entire powder bed, enabling robust scale-up correlation to pilot and production-scale Glatt granulators (e.g., VG series up to VG65). Its modular architecture supports rapid vessel exchange—facilitating comparative studies across multiple batch sizes (2.5–8 L working volume within the 10 dm³ nominal vessel)—while maintaining consistent fluid dynamics and power input per unit mass. Designed and manufactured in Germany, the VG10 complies with fundamental requirements of ISO 9001, EC Machinery Directive 2006/42/EC, and IEC 61000-6-2/6-3 for electromagnetic compatibility.

Key Features

• Interchangeable conical working vessels (10 dm³, 25 dm³, 65 dm³ nominal capacities), enabling seamless transition between lab-scale granulation batches without recalibration or revalidation
• Independent dual-drive system: 5.5 kW variable-speed agitator motor and 1.5 kW high-torque chopper motor, both digitally controlled for precise shear profile programming
• Heatable working vessel (optional jacketed configuration) supporting temperature-controlled granulation (e.g., thermolabile APIs or moisture-sensitive formulations)
• Full CIP/WIP capability with integrated spray nozzles and validated cleaning cycle protocols; water supply rated to 5 bar for effective residue removal
• Product-contact surfaces fabricated from electropolished AISI 316L stainless steel (Ra < 0.3 µm), meeting USP and ASTM A967 standards for passivation and surface integrity
• Non-product-contact metallic components constructed from AISI 304L stainless steel; all elastomeric seals certified to FDA 21 CFR 177.2600 and EU 1935/2004
• IP54-rated control cabinet with non-explosive (non-Ex) motor and drive electronics; optional ATEX-certified Ex d/Ex e configuration available for solvent-based granulation

Sample Compatibility & Compliance

The VG10 accommodates a broad spectrum of pharmaceutical powders—including APIs, excipients (microcrystalline cellulose, lactose, starch derivatives), and direct compression blends—as well as nutraceutical and fine chemical intermediates. Its closed-system operation minimizes operator exposure and environmental contamination, supporting compliance with ICH Q5A (viral safety), Q5C (stability), and Annex 1 (sterile processing considerations for non-sterile granulation). All software-driven operational parameters (agitator speed, chopper speed, granulation time, binder addition rate, temperature setpoints) are logged with electronic audit trails conforming to FDA 21 CFR Part 11 and EU Annex 11 requirements when paired with Glatt’s validated GMP-Ready Control System (GRCS). Documentation packages include IQ/OQ protocols aligned with ASTM E2500-13 and ISPE Baseline Guide Vol. 5.

Software & Data Management

The VG10 integrates with Glatt’s GRCS v4.2—a 21 CFR Part 11-compliant control platform featuring role-based user access, electronic signatures, and immutable parameter logging. Real-time monitoring includes torque consumption (proxy for granule growth), power draw trends, and thermal profiles. Exportable datasets (CSV, PDF, XML) support statistical process analysis (SPC), multivariate modeling (e.g., PCA for endpoint detection), and regulatory submission packages. Optional integration with MES systems (e.g., Siemens Opcenter, Rockwell FactoryTalk) enables batch record synchronization and automated deviation reporting per ALCOA+ principles.

Applications

• Formulation screening of binder type/concentration and granulation endpoint determination via torque rheometry
• Process characterization studies for Quality-by-Design (QbD) implementation, including DoE-based mapping of critical process parameters (CPPs)
• Development of high-dose, low-solubility, or moisture-sensitive drug products requiring tight granule size distribution control
• Supporting regulatory filings (IND, ANDA, MAA) with representative lab-scale data traceable to commercial equipment
• Training platform for operators transitioning to Glatt VG25/VG65 production units—ensuring procedural consistency across scales

FAQ

What is the minimum and maximum working volume for the VG10 vessel?

The VG10 operates within a working volume range of 2.5 L to 8 L, optimized for batch sizes typical of early-phase formulation development and stability studies.
Can the VG10 be used for solvent-based granulation?

Yes—when equipped with the optional ATEX-certified Ex-rated configuration, inert gas purging interface, and explosion-proof instrumentation, the unit supports ethanol-, isopropanol-, or acetone-based granulation under Class II/III hazardous area classifications.
Is the control system compliant with FDA 21 CFR Part 11?

The GRCS v4.2 control system is fully validated for Part 11 compliance, including electronic signatures, audit trail generation, and secure user authentication—subject to site-specific installation qualification.
How long does vessel exchange take between different nominal sizes (e.g., VG10 to VG25)?

Vessel changeover—including mechanical coupling, utility disconnect/reconnect, and sensor calibration verification—is achievable within 15 minutes using standardized quick-release fittings and pre-validated alignment fixtures.
Does Glatt provide validation documentation for the VG10?

Yes—comprehensive IQ/OQ documentation packages, including test protocols, raw data templates, and summary reports, are supplied as part of the commissioning service; PQ support is available upon request.