Medical devices play a pivotal role in drug delivery by enhancing the effectiveness of life-saving therapies. However, their efficacy is contingent upon maintaining sterility en route to the patient, which entails inherent challenges. Different medical devices and packaging materials require versatile testing methods; meanwhile, limited regulatory guidance often results in misguided testing strategies. Recent revisions to the United States Pharmacopeia (USP) Chapter <1207>, which provides guidance on container closure integrity (CCI) testing, recommended a shift towards deterministic testing to meet the stringent criteria for maintaining package integrity.
This entails a notable pivot in the industry, which has historically relied on probabilistic technologies like dye ingress and bubble emission. However, deterministic technologies yield objective, quantitative data, increasing their reliability and accuracy. Download the full article to learn more about two deterministic platforms – airborne ultrasound (ABUS) and vacuum decay – which can be used to assess seal quality and package integrity for a variety of medical device packages.