BONAPACE INCAP Automated Laboratory Capsule Filler (Dual- and Tri-Component Configuration)
| Brand | BONAPACE |
|---|---|
| Origin | Italy |
| Manufacturer Type | Authorized Distributor |
| Product Origin | Imported |
| Model | INCAP |
| Pricing | Available Upon Request |
Overview
The BONAPACE INCAP is an automated laboratory-scale capsule filler engineered for high-precision, flexible formulation development in pharmaceutical R&D, preclinical manufacturing, and quality control environments. Designed around a modular dosing architecture, the system implements volumetric filling principles using synchronized positive-displacement dosators—each independently actuated and calibrated—to deliver accurate, repeatable fill weights across heterogeneous dosage forms. Unlike conventional single-mode fillers, the INCAP supports dual- and tri-component co-filling in a single operation cycle, enabling rapid prototyping of combination capsules (e.g., immediate-release + modified-release components) without equipment reconfiguration or manual intervention. Its closed-system design minimizes operator exposure and environmental contamination, supporting compliance with ISO 14644-1 Class 7 cleanroom requirements when integrated into controlled environments.
Key Features
- Modular multi-dosator configuration: Supports up to three independent filling stations—each equipped with interchangeable dosing heads optimized for powders, granules, pellets, tablets, or low-viscosity liquids (e.g., oils, suspensions).
- Programmable co-filling logic: Enables simultaneous or sequential deposition of two or three distinct materials per capsule shell, including combinations such as pellet + powder, pellet + liquid, pellet + tablet + pellet, or triple-pellet blends.
- Real-time fill weight monitoring: Integrated load-cell-based verification at the dosing station ensures batch-level consistency; deviation alerts trigger automatic rejection of out-of-spec capsules.
- Touchscreen HMI with recipe management: Stores and recalls validated filling protocols—including dosator speed, tamping force, vacuum level, and dwell time—with user-level access control and audit trail logging.
- Tool-less changeover design: Capsule size adaptation (sizes 00–5) and material-specific dosator swaps completed in under 15 minutes without specialized tools or calibration recalibration.
- CE-marked mechanical platform with stainless-steel 316L contact surfaces and IP54-rated enclosure for compatibility with GMP-aligned facility infrastructure.
Sample Compatibility & Compliance
The INCAP accommodates a broad spectrum of solid and semi-solid dosage forms relevant to early-phase formulation studies. Powders and granules must exhibit flowability (Hausner ratio ≤ 1.4) and moisture content < 5% w/w to ensure consistent volumetric displacement. Pellets (0.5–3.0 mm diameter) and microtablets (2–5 mm) are handled via gravity-assisted alignment and positive mechanical indexing. Low-viscosity liquids (≤ 500 mPa·s) are filled using precision piston pumps with PTFE-sealed cylinders and solvent-resistant wetted parts (e.g., Hastelloy C-276). The system conforms to ICH Q5C stability guidance for equipment qualification and supports IQ/OQ documentation packages aligned with EU Annex 15 and ASTM E2500-13. Optional 21 CFR Part 11-compliant software add-on provides electronic signatures, role-based permissions, and immutable audit trails for regulated workflows.
Software & Data Management
Control firmware runs on a deterministic real-time OS with deterministic cycle timing (< ±10 ms jitter). The embedded software suite includes batch record generation (PDF/XLS export), trend analysis of fill weight standard deviation (σ), and SPC charting (X-bar/R) per lot. All operational data—including dosator position feedback, vacuum pressure logs, and capsule ejection timestamps—are timestamped with UTC synchronization and stored locally on encrypted industrial SSD. Remote diagnostics via secure TLS 1.3 tunnel enables authorized service engineers to perform predictive maintenance assessments without compromising data integrity. Data exports comply with CDISC SDTM standards for seamless integration into clinical trial supply chain databases.
Applications
- Rapid screening of multi-layered or multi-release capsule formulations during preformulation and Phase I/II clinical supply manufacturing.
- Stability-indicating capsule batches for accelerated and long-term storage studies (ICH Q1A–Q1E).
- Comparative dissolution testing of co-filled vs. separately filled reference products.
- GMP-compliant small-batch production (≤ 5,000 capsules/batch) for toxicology, bioavailability, and regulatory submission batches.
- Process characterization studies supporting Quality by Design (QbD) frameworks, including DoE-driven evaluation of dosator speed, tamping force, and shell humidity effects on content uniformity.
FAQ
What capsule sizes does the INCAP support?
Standard configurations cover gelatin and HPMC capsule shells from size 00 to size 5, with optional adapters for specialty formats (e.g., pullulan, enteric-coated).
Can the system handle heat-sensitive or hygroscopic actives?
Yes—optional inert gas purging (N₂ or Ar) and temperature-controlled dosing hoppers (15–25°C) mitigate degradation and moisture uptake during processing.
Is cleaning validation support available?
Comprehensive CIP documentation templates—including swab recovery studies, rinse sample protocols, and residue acceptance criteria aligned with ICH Q5A—are provided with the validation package.
Does the INCAP integrate with MES or LIMS platforms?
Native OPC UA server interface enables bidirectional communication with major MES (e.g., Siemens Opcenter, Rockwell FactoryTalk) and LIMS (e.g., LabVantage, Thermo SampleManager) systems via configurable tag mapping.
