Pharmaceuticals: Syringe & Closure Integrity

The Compliance Challenge: USP <1104> & ChP 4015

For Prefilled Syringes (PFS) and Cartridges, mechanical performance is a patient safety issue.

- Break-loose Force: The initial force required to start the plunger movement. If too high, it causes the "stick-slip" phenomenon, leading to dosage errors.

- Gliding Force: The sustained force during injection. It must remain smooth and flat.

KHT Technical Solution (MED Series)

Standard tensile testers often miss the "Break-loose Peak" because their sampling rate is too low. The KHT MED-01 utilizes a High-Frequency Sampling Algorithm to capture this millisecond event.

Key Test Parameters:

- Sensor Capacity: 50N (Optimized for 0-10N range)

- Force Accuracy: ±0.25N (Strictly per ChP 2025 General Chapter 4015)

- Test Speed: 100 mm/min (Syringe) / 200 mm/min (Puncture)

Beyond Syringes: Luer Lock Adaptors

With the introduction of ChP 4043, the "Adaptor Cap Pull-out Force" is now mandatory. KHT provides the specific fixture (Figure 2 in standard) and locks the test speed at exactly 20 mm/min, preventing operator error in speed settings.