Medical Device Testing: Needle sharpness and syringe actuation testing (with 21 CFR Part 11 compliance)

Hypodermic needles are tested to determine their efficacy in piercing elastomer closures on vials and how their design influences the ease of insertion into the patient's skin, influencing pain and skin trauma.

The smooth and consistent operation of the plunger is essential when administering drugs from single-use syringes.

The plunger operation force is the subject of various international test standards that seek to measure the Breakaways and Glide forces to ensure they meet manufacturing standards.

Join this live demonstration to learn more about:

• The importance of needle sharpness and syringe actuation testing
•  Selecting the ideal testing equipment and test fixtures
• Confirming 21 CFR Part 11 compliance
• Running needle sharpness and syringe actuation tests
• Establishing pass/fail criteria
• Troubleshooting inconsistent test results or non-repeatable tests