Syringe Testing

Smithers Pira is experienced in performing standard and non-standard testing on syringes and their accessory components to ensure they are safe to use and fit for purpose.

We support clients with testing as part of product development testing or to show conformance with appropriate standard requirements and/or demonstrate that the functional performance of the product satisfies the design requirements.

We perform testing on a variety of syringe types, including:

  • Hypodermic syringes
  • Oral delivery syringes: ISO 3221-7
  • Prefilled syringes
  • Glass syringes
  • Plastic syringes
  • Auto injectors
  • Needle less injectors
Syringe testing services offered include:
Dimensions
  • Barrel – inner & outer diameter, length, finger flange
  • Stopper and plunger dimensions
  • Label and graduation line spacing

 

Performance
  • Glide Force
  • Break-loose Force
  • Dead Space
  • Dose Accuracy
  • Injection force necessary to depress the plunger and eject the drug content
  • Piston seal blowback
Component Compatibility
  • Ease of Assembly
  • Resistance to Overriding
  • Stress Cracking
  • Separation Force
  • Unscrewing Torque
  • Coring Needle Test
  • Anti-needle stick (safety needle) mechanism
  • Tip cap removal force
  • Assessment of compatibility with intended devices
  • Connection incompatibility with inappropriate devices
Integrity
  • Container closure integrity
  • Dye penetration
  • Blister seal strength
  • Leakage
  • Plunger stopper movement
Resistance to breakage
  • Bite forces
  • Crush test
  • Drop test
  • Flange breakage
  • Tip breakage
  • Needle bond strength

 

Shelf-life studies
  • Real time aging
  • Accelerated aging
  • Environmental conditioning

 

Transport simulations
  • Vibration
  • Pressure
  • Thermal conditioning

​Typical standards include: ISO 11040-4, ISO 11040-5, ISO 7886-1, ISO 8537, ISO 594-1, ISO 594-2, ISO 80369-1, ISO 80369-20, BS EN 1707 and ISO 3221-7.


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