A critique of the statistical protocol in ISO 20072 for aerosol drug delivery device design verification.

Working Paper
Change log
MacKay, David 
Christescu, MS 
Tirlea, MA 

ISO 20072 is an international standard detailing the methods and testing protocols required to ensure the quality of aerosol drug delivery devices (ADDDs), for use in humans [1]. Our paper examined the pitfalls and errors in this standard, and the difficulties in its application to ADDD-producing factories. We find that the likelihood of many imperfect factories which satisfy the requirements listed in the standard actually passing the prescribed testing is minuscule. We suggest other testing protocols, which achieve the stated goals of the standard. In the specific example we consider, they also reduce the workload by around 25-fold compared with the methods specified in ISO 20072, as well as giving crucial additional advantages.

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