Dose Accuracy verification / Validation Dedicated Testing Facility

MET specialises in testing a variety of infusion devices and prefilled syringes to international FDA Guidance and ISO and IEC standards.

There are a variety of standards which refer to dose accuracy tests, these include:

  • IEC 60601 Medical electrical equipment part 2-24: Particular requirements for the safety of infusion pumps and controllers.
  • Guidance for Industry and FDA Staff:

Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with

Drugs and Biological Products

  • And a number of ISO and national standards.

 

MET has set up a dedicated dose accuracy verification laboratory which uses accurate balances and recording systems, which are linked to data recorders in a controlled atmosphere. These studies are intended to demonstrate that the volume or weight of drug/biological product expelled through the injector is the within allowed tolerances as required for a single dose or multi-dose injectors (variable and random dose patterns) and a wide variety of infusion systems.

 

MET has the facilities to assess the effects of a variety of factors on dosing, these are:

 

  • Sterilization
  • Extreme operating temperature environments (i.e., upper and lower ends of the specification)
  • Extreme storage temperature environments (i.e., upper and lower ends of the specification)
  • Extreme conditions of use testing, when applicable (i.e., upper and lower ends of the specification)
  • Packaging
  • Shipping conditions

 

There are other validation tests apply that apply to pen injectors:

 

  • Force required for assembly
  • Force required to actuate the injector
  • Force required to defeat the needle shield or other safety mechanism
  • Load testing on individual components 
  • Needle bond strength (i.e., force required to pull the needle off the injector) 
  • Needle penetration force (i.e., force available for needle insertion) 
  • Needle retraction

 Pen Injector Dose Accuracy Testing

Contact our helpful and knowledgeable team with you enquiry.