Medical Devices – Syringe & Needle Testing Fundamentals

Mecmesin - Webinar event
Moses Da Rocha

Vial sealing is a critical step in the process of ‘fill and finish’ operations for vaccines and medications, as it defines the seal quality of the final product, ensuring sterility and preventing leakage. The final strength test associated with the vial involves characterizing the force required for a hypodermic syringe needle to pass through the elastomeric closure in accordance with ISO 8362-7.

Plastic single use manual syringes require the evaluation of the force profile associated with expelling fluid from the syringe barrel. The most common test is the breakaway and glide force measurement. Breakaway force measures the initial peak force required to begin plunger movement while glide force is the average force required to continue depressing the plunger (ISO 7886-1 Annex E)

In this webinar you’ll learn an overview of the standards associated with force testing needle and syringes, calculating penetration force, and syringe plunger force, setting up actuation tests, and establishing pass/fail criteria. 

What You’ll Learn:

  • General Overview of the Needle Penetration Test
  • Calculating the needle penetration force
  • Setting up a Syringe Actuation Tests
  • Calculating the peak and average syringe plunger force
  • Establishing Pass/Fail Criteria

Who should attend? 

Manufacturing, Production and Quality Managers and Engineers involved in: 

  • Pharmaceuticals
  • Medical Device