Many devices administer pharmaceuticals or fluids to patients. MET has a dedicated laboratory for testing a variety of infusion devices, inhalers, oral dosage forms, sustained release products, droppers, creams, and sprays, all 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 multi-dose 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 dose accuracy verification laboratory at MET uses a wide variety of techniques: gravimetric, concentration measurement, spray footprint, dissolution, chromatography and others.
In our gravimetric laboratory, accurate balances are linked to data recorders in a controlled atmosphere. 21 CFR part 11 data security is also available. 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, including a specified area for cytotoxic materials.