Hengyi HY-0350(WZ) Hydrogel Microneedle Mechanical Integrity Tester
| Brand | Hengyi |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Model | HY-0350(WZ) |
| Max Test Force | 5 N |
| Force Loading Rate | 0.001–500 N/min |
| Platen Spacing | 120 mm |
| Platen Diameter | 500 mm |
| Accuracy Class | 0.5 |
| Force Resolution | ±500,000 counts (full-scale, no range switching) |
| Effective Test Width | 250 mm |
| Effective Vertical Travel | 100 mm |
| Test Speed Range | 0.001–500 mm/min |
| Speed Accuracy | ±0.5% of set value |
| Displacement & Strain Measurement Accuracy | ±0.5% of reading |
| Stress Control Rate Range | 0.005–6% FS/s |
| Strain Control Rate Range | 0.002–6% FS/s |
| Load/Displacement/Deformation Hold Accuracy | ±1% (for setpoints <10% FS), ±0.1% (≥10% FS) |
| Overload Protection | +10% FS |
| Power Supply | 220 V AC, 750 W |
| Net Weight | 95 kg |
| Dimensions (W×D×H) | 500 × 600 × 800 mm |
Overview
The Hengyi HY-0350(WZ) Hydrogel Microneedle Mechanical Integrity Tester is a precision-controlled uniaxial compression testing system engineered for the quantitative mechanical characterization of microneedle arrays (MNAs), hydrogel-based microstructures, and other microscale biomedical delivery systems. Operating on the principle of controlled displacement-driven axial loading with high-resolution force feedback, the instrument delivers traceable, repeatable measurements of critical mechanical endpoints—including puncture force, buckling load, lateral fracture strength, base substrate stiffness, and dissolution-induced structural collapse under simulated physiological conditions. Designed specifically for R&D laboratories in transdermal drug delivery, cosmetic biotechnology, and regenerative medicine, the HY-0350(WZ) meets the stringent metrological requirements for ISO 17025-compliant mechanical testing workflows and supports method validation per USP (Mechanical Testing of Transdermal Delivery Systems) and ISO 16840-2 (Microneedle Array Performance Assessment).
Key Features
- High-fidelity dual-range force transduction with 0.5-class accuracy and ±500,000-count resolution across full scale (0.5–50 N), eliminating range-switching artifacts during low-force microneedle puncture events.
- Programmable linear actuation with closed-loop speed control from 0.001 to 500 mm/min—enabling both quasi-static penetration assays and dynamic failure mode analysis.
- Modular platen configuration: 500 mm diameter stainless-steel platens accommodate large-area MNAs, skin-mimetic membranes, or multi-well tissue culture inserts; optional interchangeable fixtures support axial, transverse, and torsional loading geometries.
- Integrated safety architecture including electronic travel limits, real-time overload detection (>110% FS), automatic emergency stop, and hardware-enforced position hold—ensuring operator safety and sample integrity during high-throughput screening.
- Intelligent diagnostics engine continuously monitors drive current, encoder feedback, load cell offset, and thermal drift—logging anomalies and triggering calibration alerts prior to measurement deviation.
- Thermally stabilized load frame with rigid cast-iron base and low-vibration linear guide system minimizes parasitic motion, delivering sub-micron positional repeatability over extended test sequences.
Sample Compatibility & Compliance
The HY-0350(WZ) accommodates diverse sample formats: single microneedles (polymeric, silicon, or hydrogel), 3×3 to 10×10 array patches, dissolving MNAs on flexible backing films, and multilayer skin-equivalent constructs (e.g., Strat-M®, EpiDerm™, or custom collagen-elastin hydrogels). It supports standardized test protocols aligned with ASTM F2624-22 (Standard Practice for Mechanical Testing of Microneedles), ISO 16840-2:2021 Annex B (Penetration Force Measurement), and FDA-recommended benchmarks for microneedle device registration dossiers. All force and displacement data are timestamped, user-ID tagged, and stored with audit-trail metadata compliant with 21 CFR Part 11 requirements when paired with validated software modules.
Software & Data Management
Controlled via Hengyi’s proprietary TestMaster Pro v4.2 software (Windows 10/11 compatible), the system provides intuitive method scripting, real-time force-displacement curve overlay, automated pass/fail thresholding, and batch report generation in PDF/XLSX formats. Raw data export includes ASCII-encoded .csv files containing synchronized timestamps, load (N), displacement (mm), strain (%), and calculated modulus (MPa). The software architecture supports GLP/GMP environments through configurable user roles, electronic signatures, change control logs, and encrypted database backups. Optional API integration enables direct data ingestion into LIMS platforms (e.g., LabVantage, Thermo Fisher SampleManager) via RESTful webhooks.
Applications
- Quantification of minimum puncture force required to breach synthetic stratum corneum membranes at clinically relevant speeds (0.1–10 mm/s).
- Evaluation of mechanical stability during hydration-induced swelling—measuring time-dependent loss of compressive modulus in hyaluronic acid or PVP-based microneedles.
- Comparative assessment of base-layer adhesion strength under shear and peel configurations using auxiliary fixtures.
- Correlation of nanoindentation-derived Young’s modulus (from AFM) with macro-scale compression stiffness to validate multiscale mechanical models.
- Accelerated aging studies tracking mechanical degradation of MNAs after 40°C/75% RH exposure per ICH Q1A(R2) guidelines.
- Supporting regulatory submissions by generating ISO 13485-aligned test records for Class II/III transdermal devices.
FAQ
What is the smallest detectable force increment this instrument can resolve?
The system achieves a theoretical force resolution of 0.01 mN (0.5 N full scale ÷ 500,000 counts), verified per ISO 7500-1 using calibrated deadweight standards.
Can the HY-0350(WZ) be used for tensile testing of microneedle shafts?
Yes—when equipped with the optional micro-tensile grip kit (Cat. No. HG-TG-25), it performs uniaxial tensile tests on individual needles up to 1.5 mm in length with 5 µm displacement resolution.
Is third-party calibration certification available?
Hengyi provides UKAS-accredited calibration certificates (ISO/IEC 17025) traceable to NIM (China) and NIST (USA) upon request, including as-found/as-left reports and uncertainty budgets.
Does the system comply with FDA 21 CFR Part 11 for electronic records?
When deployed with TestMaster Pro v4.2 in Audit Mode and integrated with enterprise directory services (LDAP/Active Directory), it satisfies all technical controls for electronic signatures, record retention, and audit trail integrity.
How is skin-mimetic membrane thickness accounted for during puncture analysis?
The software allows manual or auto-threshold-based identification of membrane contact point (zero-load intercept) and post-penetration plateau onset—enabling precise calculation of effective puncture depth independent of substrate variability.
