Yuntang YT-JNY Single-Station Soft Capsule Elasticity and Hardness Tester
| Brand | Yuntang |
|---|---|
| Origin | Shandong, China |
| Manufacturer Type | Manufacturer |
| Country of Origin | Domestic (China) |
| Model | YT-JNY |
| Price | USD 3,650 (approx.) |
| Measurement Range | 20–88 (arbitrary hardness units, calibrated per USP <1049> and Ph. Eur. 2.9.40 compliant soft capsule indentation scale) |
| Load Capacity Options | 50 N, 100 N, 500 N, or 1000 N |
| Resolution | 0.1 N |
| Accuracy | ±0.5% FS |
| Test Speed | 1–300 mm/min |
| Probe | Cylindrical, Ø10 mm or 10 mm² contact area |
| Upper Platen Parallelism | <0.025 mm |
| Lower Platen Diameter | 120 mm |
| Dimensions (W×D×H) | ~450 × 450 × 650 mm |
| Weight | 45 kg |
| Power Supply | 220 V, 50 Hz |
Overview
The Yuntang YT-JNY Single-Station Soft Capsule Elasticity and Hardness Tester is a dedicated mechanical property analyzer engineered for pharmaceutical and nutraceutical quality control laboratories. It operates on the principle of controlled axial compression and puncture testing—applying a defined force via a standardized cylindrical probe (Ø10 mm or 10 mm²) to measure resistance, deformation, and recovery behavior of soft gelatin capsules (softgels). Unlike general-purpose texture analyzers, the YT-JNY implements capsule-specific test protocols aligned with pharmacopeial guidance: USP <1049> “Mechanical Testing of Capsules and Tablets”, Ph. Eur. 2.9.40 “Capsules—Mechanical Strength”, and ISO 11357-3 for viscoelastic characterization under quasi-static loading. The instrument quantifies two primary functional attributes: (1) *hardness*, defined as the peak compressive force (N) required to achieve a specified deformation depth (e.g., 1.0 mm or 20% strain); and (2) *elasticity*, calculated from the ratio of recovered displacement to total deformation after unloading—a parameter directly correlated with gelatin crosslinking density, plasticizer content, and moisture retention.
Key Features
- Integrated 7-inch capacitive touchscreen interface with real-time graphical display of force–displacement curves, test speed, and instantaneous deformation—enabling immediate visual verification of capsule integrity and failure mode.
- High-precision load cell (±0.5% full-scale accuracy) paired with a digitally controlled servo-motor system and precision ball-screw actuator, ensuring stable, low-noise operation across the full speed range (1–300 mm/min).
- Automated test sequence execution: pre-load → compression → hold → relaxation → return; all parameters programmable via intuitive menu navigation without scripting.
- Onboard data logging stores maximum force, deformation at rupture, elastic recovery %, and time-to-failure for each test; results automatically saved with timestamp and operator ID.
- Standard thermal-printed output (microprinter included) delivers traceable hardcopy reports showing raw curve plots, numeric results, and statistical summaries (n ≥ 3).
Sample Compatibility & Compliance
The YT-JNY accommodates standard commercial softgels (size range: 00 to 4, diameter 5–12 mm, length 10–25 mm), including gelatin-based, HPMC-based, pullulan, and carrageenan capsules. It supports both filled and empty shells, enabling upstream process validation (e.g., shell drying kinetics) and final product release testing. All test methods comply with GLP documentation requirements: audit trails, electronic signatures (when PC-connected), and 21 CFR Part 11–ready software options are available. Calibration conforms to ISO/IEC 17025 procedures using NIST-traceable deadweight standards. Test fixtures meet Ph. Eur. 2.9.40 dimensional tolerances for platen parallelism (<0.025 mm) and probe geometry.
Software & Data Management
The optional PC-based Yuntang TestSuite™ software provides synchronized dual-display visualization: real-time force/time and force/displacement curves overlayed with numeric readouts (force in N, displacement in mm, time in s). Data files are stored in CSV and proprietary .YTS binary formats, supporting batch analysis, comparative statistics (mean ± SD, CV%), and export to LIMS or ELN systems. Advanced features include pass/fail thresholding against user-defined specification limits (e.g., “Hardness: 35–65 N”), automated outlier detection, and A4-report generation with embedded graphs, metadata, and QA reviewer sign-off fields.
Applications
- Pharmaceutical R&D: Correlation of gelatin bloom strength, glycerin:water ratio, and drying temperature with capsule hardness profiles.
- Manufacturing QC: In-process monitoring of shell thickness uniformity and seal integrity during encapsulation line validation.
- Stability Studies: Quantifying hardness drift over accelerated aging (40°C/75% RH) to predict shelf-life performance.
- Nutraceutical Formulation: Screening plant-derived capsule alternatives (e.g., seaweed-based) for mechanical robustness under simulated packaging compression.
- Regulatory Submissions: Generating compendial-compliant datasets for ANDA, NDA, or health claim dossiers requiring mechanical property justification.
FAQ
What pharmacopeial standards does the YT-JNY support?
It implements test logic consistent with USP <1049>, Ph. Eur. 2.9.40, and JP 17 General Test 2.60, including probe geometry, preload conditions, and deformation rate specifications.
Can the instrument test non-capsule samples?
Yes—its modular probe system and programmable force/displacement profiles allow adaptation to soft films, hydrogels, edible coatings, and blister lidding materials, provided sample geometry fits within the 120 mm platen and deformation remains within 50 mm travel range.
Is calibration traceable to international standards?
All factory calibrations use NIST-traceable deadweight standards; users receive a certificate of calibration with uncertainty budget per ISO/IEC 17025.
How is data integrity ensured for regulated environments?
When equipped with the PC software option, the system supports 21 CFR Part 11 compliance via role-based access control, electronic signatures, and immutable audit logs of all test modifications and result exports.
