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

Our syringe testing services include:

Dimensions

  • Barrel – inner and 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

  • Dye penetration
  • Blister seal strength
  • Leakage

 

Resistance to breakage

  • Bite forces
  • Crush test
  • Drop test

 

Shelf-life studies

  • Real-time aging
  • Accelerated aging
  • Environmental conditioning

 

Transport simulations

  • Vibration
  • Pressure
  • Thermal conditioning

Standards

​Typical standards we test to 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.

Our expert team can also create bespoke test methods in order to quantifiably assess properties which might not otherwise be evaluated within the boundaries of standard testing.

Quality and Accreditation 

Our laboratories are UKAS accredited to ISO 17025, and we can undertake activities with GMP compliance if required.

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