KY-20 Particle Strength Tester by Keyuan Instruments
| Brand | Keyuan Instruments |
|---|---|
| Origin | Jiangsu, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | KY-20 |
| Force Range Options | 0–100 N / 0–200 N / 0–500 N (user-selectable) |
| Sensitivity | 0.1 N |
| Accuracy | ≤0.5% F.S. ± 0.1 N |
| Particle Diameter Capacity | 0–20 mm (granules) |
Overview
The KY-20 Particle Strength Tester is a precision mechanical compression testing instrument engineered for quantitative assessment of mechanical integrity in discrete solid dosage forms and agricultural or food-grade particulates. It operates on the fundamental principle of uniaxial compressive loading—applying controlled, gradually increasing force perpendicular to the particle’s major axis until structural failure (crushing, cracking, or deformation beyond defined thresholds) occurs. The system captures peak load at failure as the primary strength metric, expressed in newtons (N), enabling direct comparison across formulation batches, raw material lots, or post-processing stability studies. Designed specifically for pharmaceutical, agrochemical, and food quality control laboratories, the KY-20 complies with core mechanical testing paradigms referenced in USP “Mechanical Testing of Solid Dosage Forms”, ISO 8503-2 (surface profile roughness correlation to coating adhesion), and ASTM D6182 (compressive strength of granular fertilizers). Its robust architecture supports routine QC workflows requiring high reproducibility under GLP-compliant documentation protocols.
Key Features
- Triple-range selectable load cell configuration (0–100 N, 0–200 N, or 0–500 N) enables optimal resolution across diverse sample classes—from low-strength coated tablets to high-density fertilizer pellets.
- High-resolution force transduction with 0.1 N sensitivity ensures detection of subtle inter-batch variations in tablet hardness or granule friability.
- Dual-diameter sample stage accommodates both standard pharmaceutical granules (Ø 0–20 mm) and larger horticultural specimens (Ø 20–200 mm), eliminating need for auxiliary fixtures.
- Motor-driven, programmable platen displacement with real-time force–displacement curve acquisition supports advanced failure mode analysis beyond simple peak load reporting.
- Stainless steel test chamber and corrosion-resistant load train components ensure long-term dimensional stability and resistance to chemical exposure during cleaning validation cycles.
- Integrated overload protection and emergency stop circuitry meet IEC 61000-6-2 electromagnetic compatibility and functional safety requirements for laboratory instrumentation.
Sample Compatibility & Compliance
The KY-20 is validated for use with compressed tablets, extruded granules, spheroidized pellets, coated beads, fertilizer prills, and whole fruits (e.g., apples, citrus, berries) where mechanical resilience correlates directly with shelf-life, handling durability, or consumer acceptability. Sample geometry must be approximately spherical or cylindrical to ensure consistent load distribution; irregular shapes require orientation standardization per SOP. The instrument satisfies essential regulatory expectations for equipment qualification: Installation Qualification (IQ) templates and Operational Qualification (OQ) test protocols—including linearity verification across all three ranges, repeatability assessment (n ≥ 10 at 50% and 90% of full scale), and zero drift monitoring—are provided with delivery. Data output conforms to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) when paired with compliant data management practices.
Software & Data Management
The KY-20 interfaces via USB 2.0 with Keyuan’s proprietary PC-based software (v3.2+), which supports real-time force–time and force–displacement visualization, automatic peak detection, statistical summary (mean, SD, RSD, min/max), and export to CSV, PDF, or XML formats. Audit trail functionality records all user actions—including method changes, calibration events, and result deletions—with timestamp, operator ID, and reason for change. When deployed in regulated environments, the software may be configured to comply with FDA 21 CFR Part 11 requirements through optional electronic signature modules and role-based access control (RBAC). Raw data files are stored in non-proprietary binary format with embedded metadata (test date, operator, sample ID, range setting, environmental temperature/humidity if logged externally), facilitating third-party analysis or integration into LIMS platforms.
Applications
- Pharmaceutical: Quantifying tablet hardness pre- and post-coating; evaluating granule crush resistance after fluid-bed drying; assessing binder efficacy in direct compression formulations.
- Agricultural Chemistry: Measuring mechanical stability of NPK compound fertilizers during bulk transport and pneumatic conveying; validating pellet integrity under simulated storage compression loads.
- Food Science: Determining firmness thresholds for minimally processed fruits; correlating crushing force with ripeness indices or post-harvest storage duration.
- Material Science: Screening excipient–API compaction behavior; benchmarking alternative granulation technologies (e.g., hot-melt vs. wet granulation) based on interparticulate bonding strength.
- Regulatory Support: Generating data for ANDA submissions requiring mechanical property justification; supporting stability protocol development per ICH Q1/Q5 guidelines.
FAQ
What standards does the KY-20 comply with for pharmaceutical testing?
The KY-20 aligns with measurement principles outlined in USP , EP 2.9.8, and JP 17 General Chapter 2.98, particularly regarding apparatus geometry, platen speed, and force reporting conventions.
Can the instrument be calibrated in-house using traceable weights?
Yes—calibration is performed using NIST-traceable deadweight standards applied directly to the load cell; full calibration certificates (including uncertainty budgets) are issued upon request.
Is the software validated for GMP environments?
The base software is 21 CFR Part 11–ready; formal validation packages (IQ/OQ/PQ) and CSV documentation are available as optional add-ons.
How is sample alignment ensured during testing?
A precision V-groove positioning fixture (included) centers cylindrical or spherical samples reproducibly; custom jigs for irregular geometries can be fabricated upon request.
Does the KY-20 support automated batch testing?
Yes—via scriptable test sequences in the software, enabling unattended execution of up to 99 samples with auto-incrementing IDs and pass/fail logic based on user-defined limits.
