Dose Accuracy verification / Validation Dedicated Testing Facility
Many devices administer pharmaceuticals or fluids to patients. MET has a dedicated laboratory for a variety of infusion devices, sustained release products, prefilled syringes, creams and sprays, to international FDA Guidance and ISO and IEC standards.
There are a variety of standards guidance and pharmacopeia monographs 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
- USP <698> Deliverable Volume
- USP <755> Minimum Fill
- USP <905> Uniformity of Dosage Units
- Ph.Eur. 2.9.27. Uniformity of mass of delivered doses from multidose containers
And a number of ISO and national standards, examples are:
- ISO 28620 Medical devices — Non-electrically driven portable infusion devices
- ISO 11608: Needle-based Injections for Medical Use
- ISO 8536: Infusion equipment for medical use
- The requirement applies to dispensers for sprays, creams and oral doses, syringes and injectors, droppers and inhalers.
MET has set up a dedicated dose accuracy verification laboratory which uses a wide variety of techniques: gravimetric, concentration measurement, spray footprint, dissolution, chromatography and more.
In our gravimetric laboratory, accurate balances are linked to data recorders in a controlled atmosphere. These studies can be applied to syringe pumps, pens and prefilled syringes.
MET also has the facilities to assess the effects of temperature, humidity and vibration on dosing