The definitive solution for ChP 2025 and USP <1104> compliance. Specialized for Syringe Gliding, Rubber Stopper Puncture, and Ampoule Breaking with ±0.25N high-precision accuracy and GMP-ready software.
Selection Guide: Need to test rigid medical devices like syringes or ampoules? Choose the MED Series. Its rigid single-column frame and bi-directional sensors are optimized for puncture and compression tests, unlike standard film testers.
The KHT MED-01 is a dedicated compliance station for the pharmaceutical industry. Engineered to meet the stringent requirements of China Pharmacopoeia 2025 (General Chapters 4015, 4043) and USP <1104>, it eliminates the risk of non-compliance in GMP audits.
Precision Where It Matters: While standard testers struggle with low forces, the MED-01 excels. Equipped with a 50N High-Precision Sensor, it achieves the ±0.25N accuracy mandated by ChP 4015. It also supports the 20mm/min ultra-low speed required for the new 'Luer Lock Adaptor Pull-out' test.
| Parameter | Value |
|---|---|
| Test Range | 0-250N (Standard) / 50N (High Precision Option) |
| Load Cell Accuracy | 0.5 Class (±0.5% of reading) |
| Force Resolution | 0.001N (Critical for ChP 4015 compliance) |
| Stroke Effective | 400 mm (Optimized for Medical Devices) |
| Test Speed | 1 - 500 mm/min (Stepless) |
| Speed Accuracy | ±0.5% (Pre-set speeds: 20, 50, 100 mm/min) |
| Control System | Embedded Computer with 7-inch Touchscreen |
| Data Output | RS232 / USB / Integrated Micro-Printer |
| Dimensions | 400 × 340 × 800 mm |
| Net Weight | 28 kg |
| Application | Description |
|---|---|
| Pharma Packaging | Validating rubber stopper puncture force (ChP 4015). |
| Drug Delivery | Measuring syringe plunger gliding smoothness (USP 1104). |
| Medical Glass | Testing breaking strength of glass ampoules (GB 2637). |
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