The challenge
Kindeva Drug Delivery, formerly known as 3M Health Care, require traceability of a component of their asthma inhalers. NPL calibrate an artefact for them to use in manufacturing the pressurised metered dose inhaler (pMDI). Calibration is carried out regularly, with the frequency dependent on the amount of use and the environmental conditions under which the artefact is used. If the artefact is not calibrated, Kindeva Drug Delivery cannot check the quality of their product or release their products.
At the start of the COVID-19 crisis Kindeva Drug Delivery were informed about changes to NPL’s operational activities due to unprecedented challenge and the closing of some of the NPL site.They were also asked whether the artefact was used to support the effort to mitigate COVID-19 impact.
Kindeva Drug Delivery confirmed that the artefact is used in manufacturing asthma inhaler components and was required as soon as possible to meet the expected increase in demand during the pandemic.Therefore, this work became one of the critical services that were provided by NPL during the COVID-19 period.
The solution
The pMDI are metal inhalers made up of a metering valve, which delivers a precise amount of dosage of the medication, and the canister component, which holds all the medication.The canister components are usually aluminium and manufactured in an engineering environment, and after manufacturing they are thoroughly cleaned to eliminate manufacturing oils and other contact materials.
These medical devices have strict regulatory requirements that must be met in terms of residual contact materials, one of which is related to the level of foreign particulate matter (FPM), which must be controlled.
One of the ways to control FPM is to carry out release testing using a microscope to count particles above a certain size. Release test means collecting the particles from the canister component by filling the canister with de-ionised water and follow a specific method to collect these extracts on to a filter paper which can be measured and counted using the microscope. This test must be carried out before the canister components can proceed to further downstream processes.
The NPL Reference Stage Graticule (RSG) is key to this process. Before every test, the microscope that is used to count the particles from the release test needs to be verified using the RSG. If the microscope does not meet the required system suitability criteria, it is re-calibrated using the artefact from NPL.
The benefit
NPL was able to respond to the customer and complete the artefact calibration, as well as deliver the artefact on time. Kindeva Drug Delivery was able to inspect asthma inhaler components with traceability and release the product without any delay to meet increased demand during the COVID-19 pandemic.