SOP: Luer Lock Adaptor Pull-out (ChP 4043)
A step-by-step guide to measuring the adaptor cap secureness of prefilled syringes using the KHT specialized fixture.
The New Requirement
Prefilled syringes with Luer Lock adaptors face a specific risk: the adaptor cap can detach during needle removal.
• Regulation: ChP 2025 General Chapter 4043 introduces the "Adaptor Cap Pull-out Force" test.
• Critical Parameter: The test speed must be extremely slow: 20mm/min.
Step-by-Step with KHT MED Series
Step 1: Install the Fixture
• Mount the KHT Syringe Barrel Fixture (Lower) and the Pull-out Clamp (Upper). This setup corresponds to Figure 2 in the standard.
Step 2: Positioning
• Insert the syringe barrel into the lower holder.
• Clamp the Luer Lock adaptor cap with the upper grip. Ensure vertical alignment to avoid shear forces.
Step 3: The Test
• Select the "Adaptor Pull" program on the touchscreen.
• The machine moves at precisely 20mm/min.
Step 4: Analysis
• The system records the peak force required to separate the cap.
• Pass Criteria: Ensure the peak force meets the specified Newton limit for your syringe size (e.g., 1ml Long vs 1ml Standard).
