ISO 20072 Aerosol drug Delivery Device Design Verification, Requirements and Test Methods

EUROLAB laboratory provides testing and compliance services within the scope of ISO 20072 standard. ISO 20072 applies to the design, labeling, instructions for use, and testing requirements for hand-held single- and multi-use aerosol drug delivery devices (ADDDs) intended to deliver a metered or pre-measured aerosolized drug via:

This International standard applies to both refillable and disposable devices for personal use.

ISO 20072 is designed for device design validation, not pharmaceutical product quality assessment. The purpose of this International standard is to verify by laboratory (in-vitro) testing that the ADDD design consistently meets the manufacturer's design specification, meeting a device functionality profile and system validation testing, both determined and evaluated from a risk assessment.

There are times when this standard is covered by the ISO 27427 standard. The intended use of aerosol drug delivery devices and the risk assessment of the device determine which international standard the manufacturer has chosen for design verification. Briefly, this standard describes the process of determining the design verification of aerosol drug delivery devices along with a risk-based device functionality profile with a drug, placebo, or a representative drug.

EUROLAB assists manufacturers with ISO 20072 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.