Pen Injector & Insulin Pen Testing

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Pen Injector & Insulin Pen Testing

Testing pen injectors, insulin pens and other auto-injectors is an important step in determining the quality and performance of the product.

What are the industry standards for testing pen injectors and insulin pens?

  • ISO 11608 needle-based injection systems for medical use

What is ISO 11608?

  • ISO 11608-1: Needle-based injection systems
  • ISO 11608-2: Needles
  • ISO 11608-3: Finished containers (referenced in USP <1382> and <USP 382>
  • ISO 11608-4: Needle-based injection systems containing electronics
  • ISO 11608-5: Automated functions
  • ISO 11608-6: On-body delivery systems
  • ISO 11608-3: Breakaway force, glide force, and leak tightness

What tests are required for auto-injectors?

  • Force to remove the safety cap
  • Activation force and displacement
  • Weight of the drug volume
  • Effective length of the needle during injection using an optical micrometer
  • Force to displace the needle guard