Core Philosophy of the Modular Universal Platform

Pharmaceutical research and development (R&D) laboratories, Galenic formulation departments, and pilot plants frequently encounter severe constraints, including limited benchtop footprint, high capital expenditure (CAPEX) for standalone equipment, and laborious cleaning validation associated with frequent active pharmaceutical ingredient (API) changeovers.

The Pharmag Pilot Plant System from the German Pharma Test Group addresses these challenges by implementing the proven architecture of a Universal Drive Unit coupled with Plug-and-Play Processing Modules:

• P-UAM Universal Drive Motor: Delivers highly stable and precise variable-speed driving power from 50 to 450 rpm (with a speed accuracy of ±1 rpm) driven by a robust 600W motor.

• UGD Universal Gear Drive: Features a 1:10 reduction ratio, delivering high-torque output at low rotational speeds from 5 to 45 rpm (nominal torque approx. 60 Nm). The output angle can be freely adjusted by 90 degrees, specifically engineered for high-viscosity wet mass kneading and heavy-duty extrusion granulation.

• Tool-Free Quick-Lock Flange: Every processing module is equipped with a standardized quick-docking flange interface. Operators can rapidly swap between mixing, granulating, spheronizing, dosing, or tableting modules within minutes without specialized tools, maximizing laboratory space efficiency and significantly streamlining cleaning validation.

Complete Oral Solid Dosage (OSD) Granulation Process Chain

A comprehensive pilot-scale granulation and validation process chain consists of four core unit operations:

• Stage 1: Dry Blending & Wet Mass Kneading (utilizing the P-PM-4 or PSM-8)

• Stage 2: Wet Extrusion Granulation & Post-Drying Sizing/Milling (utilizing the WG-30 paired with the UGD Gearbox)

• Stage 3: Centrifugal Spheronization for Specialty Formulations (utilizing the optional PLT module)

• Stage 4: Particle Size Distribution (PSD) QC Qualification & Compressibility Validation (utilizing the AS-200 Sieve Shaker and Riva MiniPress Tableting series)

Detailed Core Equipment Models and Selection Criteria

1. P-PM-4 Planetary Shear Mixer (Primary Choice for Wet Mass Kneading)

• Operating Principle: Utilizes planetary revolution and high-speed self-rotation to generate intensive axial and radial shear forces. Materials undergo continuous shearing, folding, and recombining within the bowl, completely eliminating dead zones.

• Key Specifications: Total volume of 4.0 L with a maximum working capacity of up to 2.5 L. Operating speed ranges from 50 to 450 rpm (directly driven by the P-UAM drive unit). Contact parts are fabricated from mirror-polished AISI 316 or 304 stainless steel, and the top cover comes standard with a magnetic reed safety interlock switch.

• Target Applications: Critical pre-treatment for wet granulation. Homogeneously incorporates APIs, excipients, and liquid binders into an ideal wet mass achieving the benchmark "lump upon squeezing, crumble upon light pressure" consistency.

2. PSM-8 Double Ribbon Shear Mixer (Optimal for Large-Volume Dry Blending)

• Operating Principle: Employs bidirectional counter-current helical ribbons to induce continuous convective mixing with gentle shear, effectively preserving native crystal forms and fragile particle structures.

• Key Specifications: Total volume of 8.0 L with a maximum operating capacity of up to 5.0 L.

• Target Applications: Ideal for larger-batch powder dry blending, ensuring high dispersion homogeneity of low-dose active ingredients within high-ratio excipient matrices.

3. WG-30 Oscillating Granulator and Sizing Module (Flagship Core of the Workflow)

• Operating Principle: Driven by the oscillating rotor's bidirectional reciprocating motion, material is gently and uniformly extruded or sized through an arc-shaped stainless steel sieve screen.

• Key Specifications: Maximum throughput up to 30 kg/h. Sieve apertures range from 0.5 mm to 3.0 mm, secured by a quick-clamp tensioning mechanism. Must be powered via the UGD reduction gearbox (operating speed 5 to 45 rpm). All product-wetted parts are manufactured from pharma-grade AISI 316L stainless steel, fully compatible with steam autoclave sterilization.

• Dual Process Functionality:

  • Wet Extrusion Granulation: Forces kneaded wet mass through the screen into uniform cylindrical extrudates, preventing agglomeration and massive caking during subsequent drying.

  • Dry Milling & Sizing: De-agglomerates and uniformly sizes dried granules or compacted slugs, eliminating oversized clusters while strictly minimizing the generation of excessive fines to provide optimum powder flowability for downstream tablet compression or encapsulation.

4. PLT Spheronizer Module (Dedicated to Pellets and Modified-Release Formulations)

• Operating Principle: Utilizes the centrifugal force generated by an inclined rotating friction plate combined with precision-machined surface cross-hatches. Materials tumble, self-rotate, and collide at high velocity to achieve uniform spherical rounding.

• Key Specifications: Both inclination angle and rotational speed can be precisely modulated; interior walls feature high-grade mirror polishing to prevent material sticking.

• Target Applications: Formulation development of Multiple Unit Pellet Systems (MUPS) and controlled-release coated pellets. Rapidly rounds cylindrical wet extrudates from the WG-30 into spherical pellets with high sphericity (> 0.9).

5. AS-200 Laboratory Vibratory Sieve Shaker (Standard for Particle Size Distribution Qualification)

• Operating Principle: Incorporates patented 3D throwing action technology. The electromagnetic drive creates a three-dimensional throwing and rotational vortex motion across the sieve surface, preventing sieve mesh blinding.

• Key Specifications: Measuring range from 20 µm to 25 mm, with a single-batch sample load capacity of up to 3 kg. Accommodates up to 9 standard sieve frames (Ø 200 mm, height 50 mm). Fully compliant with ISO 3310-1 and ASTM E11 standards.

• Target Applications: Particle size distribution (PSD) qualification following granulation. Accurately monitors D10, D50, D90 percentiles and fines percentage, providing statutory particle distribution data required for ANDA / NDA regulatory filings.

6. Riva MiniPress M II Eccentric Single Punch Tablet Press (Small-Scale Feasibility Validation)

• Operating Principle: Features an eccentric single-punch mechanical design where a gravity feed shoe is driven back and forth by a central crankshaft, executing continuous single-station tablet compression.

• Key Specifications: Maximum main compression force up to 60 kN (6 tons). Maximum output up to 6,000 tablets/h. Upper punch penetration is continuously adjustable from 3 to 14 mm; lower punch filling depth reaches up to 18 mm. Supports maximum tablet diameters of 24 mm (round) and 10 x 25 mm (shaped). Single-phase 230V, motor rating 1.5 kW.

• Target Applications: Requires only tens to hundreds of grams of granulated sample to initiate compression trials. Rapidly evaluates granule flowability, die fill weight uniformity, compressibility profiles (Heckel plots), and tablet tensile strength.

7. MiniPress II Fully Automated Rotary Tablet Press (Benchmark for Scale-Up Process Simulation)

• Operating Principle: Fully automated rotary multi-station continuous compression equipped with dedicated pre-compression and main compression rollers, accompanied by an integrated overload protection system.

• Key Specifications: Maximum pre-compression force up to 20 kN; maximum main compression force up to 60 kN. Turret speed is continuously adjustable from 12 to 32 rpm via variable-frequency drive. Turret configurations include Mono Tooling D (8 stations, up to 15,000 tablets/h), B (10 stations, up to 19,000 tablets/h), BB (12 stations, up to 19,000 tablets/h), and multi-tooling hybrid setups. Equipped with a motorized Force Feeder as standard.

• Target Applications: Pilot-scale batch manufacturing and commercial scale-up parameter simulation. Accurately characterizes de-aeration efficiency under high-speed filling conditions, eliminating common industrial tableting defects such as capping and lamination.

Pharmaceutical R&D Scenarios and Recommended System Configurations

Package A: Standard Solid Dosage R&D & Compression Pilot Workstation (The Classic R&D Setup)

• Target Application: Routine oral solid dosage (OSD) formulation screening, wet granulation optimization, and compression parameter mapping.

• Recommended Configuration:

  • Drive Unit: P-UAM Universal Drive Motor

  • Reduction Gear: UGD Universal Gear Drive

  • Wet Mass Kneading: P-PM-4 Planetary Mixer (4.0 L)

  • Granulation & Sizing: WG-30 Oscillating Granulator (standard with 0.8 mm, 1.2 mm, and 1.8 mm SS screens)

  • Compression Validation: Riva MiniPress M II Single Punch Tablet Press

• Package Synergy: A single universal drive unit seamlessly powers both wet mass kneading and granulating/sizing operations. Compared to purchasing multiple standalone units, it delivers up to 60% CAPEX savings and drastically conserves laboratory footprint, representing the most cost-effective investment for OSD formulation labs.

Package B: Pilot Pellet & Modified-Release Granule Workstation (Dedicated to MUPS & Pellets)

• Target Application: Development of enteric-coated pellets, sustained-release beads, Multiple Unit Pellet Systems (MUPS), and high-potency encapsulated spheroids.

• Recommended Configuration:

  • Drive & Extrusion: P-UAM Universal Drive Unit + UGD Universal Gear Drive + WG-30 Oscillating Granulator (for wet mass extrusion)

  • Spheronizing Module: PLT Spheronizer Module (for transforming extrudates into high-sphericity beads)

  • Fractionation & Grading: AS-200 Laboratory Vibratory Sieve Shaker (strictly fractionating oversized beads and fines to guarantee a uniform substrate for fluid bed coating)

• Package Synergy: Yields high-specification pellets with sphericity exceeding 0.9 directly on a benchtop laboratory scale, bypassing the substantial energy consumption, equipment footprint, and costly API losses associated with running large pilot fluid bed systems during early-stage formulation.

Professional Technical Consultation & Online Sample Trial Scheduling

Visit the official Chin-Wei Technology website or submit an online inquiry. Our factory-certified technical specialists are ready to provide tailored regulatory compliance support and equipment sizing solutions for your laboratory:

• Official Website: www.dissolution.com.tw

• Product Portal: Tablet & Capsule Formulation Pilot Systems

• Technical Consultation Hotline: +886-4-2241-1607