Dose Accuracy verification / Validation Dedicated Testing Facility
Dec 23, 2016
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:
- 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)
- 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
Contact our helpful and knowledgeable team with you enquiry.
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