YaCheng / PILOTECH YC910 Benchtop Multifunctional Pelletizer and Film Coater

Overview

The YaCheng / PILOTECH YC910 Benchtop Multifunctional Pelletizer and Film Coater is an integrated, laboratory-scale unit engineered for the wet extrusion–spheronization–coating workflow essential in solid oral dosage development. It operates on the principle of controlled mechanical deformation and hydrodynamic spheroidization: powder blends—comprising active pharmaceutical ingredients (APIs), excipients, and aqueous or organic binder solutions—are first extruded through a perforated die plate under precise screw-driven pressure. The resulting cylindrical strands are then fractured and subjected to high-shear rotational forces within a centrifugal spheronization disc, where simultaneous fluid addition and mechanical attrition promote surface plasticization and progressive rounding. The built-in chilled water circulation system actively cools both the extruder barrel and feed hopper, maintaining process temperatures below 30 °C—critical for thermolabile APIs, proteins, probiotics, or amorphous dispersions. This thermal management ensures minimal degradation, preserved crystallinity, and consistent rheological behavior during extrusion, directly supporting ICH Q5C stability requirements and early-phase formulation screening under GLP-compliant conditions.

Key Features

• Integrated wet extrusion, spheronization, and optional film-coating capability in a single compact benchtop platform—eliminating inter-unit transfer and cross-contamination risks.
• Adjustable extrusion screw speed (0–50 rpm) and independently controllable spheronization disc rotation (0–1400 rpm) enable fine-tuned optimization of pellet morphology, density, and friability.
• Built-in recirculating chiller system maintains ≤28 °C at extruder barrel and feed zone—validated for sustained operation with heat-sensitive compounds including peptides, enzymes, and low-melting-point actives.
• Modular sieve plate configuration supports interchangeable die geometries (0.3–1.5 mm aperture), allowing granule size targeting across narrow distributions (span <1.2) without post-processing sieving.
• Gas-assisted spheronization: Clean, filtered air introduced via radial slots beneath the rotating disc induces mild fluidization—reducing inter-particle adhesion and enhancing sphericity (sphericity index >0.92 per USP <1151>).
• Full stainless-steel 316L contact surfaces, IP54-rated enclosure, and tool-free access panels comply with FDA 21 CFR Part 11–ready operational hygiene standards and facilitate rapid cleaning validation (CIP protocols supported).

Sample Compatibility & Compliance

The YC910 accommodates a broad spectrum of formulation matrices—including direct compression blends, melt extrudates (HME preforms), microcrystalline cellulose–based systems, and high-viscosity polymer solutions (e.g., HPMC, Eudragit® dispersions). Its low-volume throughput (1–3 kg/hr) aligns with ICH Q5A–Q5E comparability studies, Phase I/II clinical batch production, and DOE-based formulation scouting. All wet-contact components meet ASME BPE-2021 surface finish specifications (Ra ≤0.4 µm), and documentation packages include material traceability certificates, FAT/SAT reports, and IQ/OQ templates compatible with GMP Annex 15 and EU GMP Annex 15 frameworks. The system supports audit-ready electronic batch records when interfaced with validated LIMS or MES platforms.

Software & Data Management

Equipped with a 7-inch industrial touchscreen HMI running embedded real-time control firmware, the YC910 logs timestamped parameters—including torque, temperature, rpm, air flow rate, and cycle duration—with 100 ms resolution. Data export is available via USB 2.0 or Ethernet (Modbus TCP) into CSV or ASTM E1382-compliant formats. Audit trail functionality records all operator actions, parameter changes, and alarm events with user ID and time stamp—fully compliant with FDA 21 CFR Part 11 electronic signature and record retention requirements. Optional integration with PI System™ or DeltaV DCS enables centralized monitoring across multi-unit labs.

Applications

• Development of immediate-release and modified-release multiparticulate systems (e.g., pH-dependent, time-delayed, or colonic-targeted pellets).
• Scale-down modeling for commercial extrusion–spheronization lines (e.g., GlobeCore, Caleva, or Freund Vector units).
• Formulation feasibility assessment of high-potency APIs (<1% w/w), poorly soluble compounds (BCS II/IV), and combination products.
• GMP-aligned pilot batches for toxicology, stability, and bioequivalence studies per ICH M4, Q1–Q5 guidelines.
• Food-grade functional ingredient encapsulation (e.g., probiotics, omega-3 oils, vitamins) under FSSC 22000 or SQF Level 3 certified environments.

FAQ

Can the YC910 be used for solvent-based extrusion processes?

Yes—the system supports ethanol-, isopropanol-, and acetone-based binder solutions when configured with explosion-proof electrical components and ATEX-certified air handling modules (optional add-on).
Is remote monitoring and control possible?

Standard Ethernet connectivity enables SCADA-level supervision; optional OPC UA server license permits secure cloud-based dashboards and predictive maintenance alerts.
What validation support is provided?

Factory-accepted test (FAT) documentation, IQ/OQ protocol templates, and calibration certificates for all critical sensors (torque, temperature, rpm) are included with shipment.
Does the unit meet cleanroom compatibility requirements?

The YC910 meets ISO 14644-1 Class 7 (10,000) particulate limits when operated inside a laminar flow hood or isolator; full ISO 5 integration requires custom HEPA-integrated canopy (available as turnkey option).