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Advancing Metered-Dose Inhaler Testing
Copley Scientific Launches BAC™ 2100 Breath Actuation Controller
Capitalising on the success of the Critical Flow Controller Model TPK™ 2100 for dry powder inhalers (DPIs), Copley Scientific has launched the BAC™ 2100, an advanced Breath Actuation Controller to help automate flow control when testing metered - dose inhalers (MDIs) for delivered dose uniformity and aerodynamic particle size distribution.
The new BAC™ 2100, which replaces its predecessor, the BAC™ 2000, provides flow control for a range of MDI applications, including a time delay feature for the actuation of MDIs when used with spacers and valved holding chambers (VHCs) according to new USP Chapter <1602>. It can also be used for flow volume control when testing regular MDIs according to USP Chapter <601> and for the automatic actuation of breath-actuated MDIs. Advanced features include a fully automated in situ cascade impactor leak testing function and extensive data reporting capabilities, with the choice of outputting data to a printer or computer. Test duration is calculated automatically from the required flow volume – typically 2 litres in the case of MDIs – based on the measured flow rate, derived from a connected flow meter. The menu system has further been enhanced to guide the user through the required steps to ensure consistency and error free completion of the test method.
As an optional accessory to the BAC™ 2100, a new MDI Actuation Sensor has been made available; a discrete device that clips onto the MDI canister, it senses the manual actuation of the MDI and precisely triggers the BAC™ 2100 for subsequent time delay and/or flow volume control, simplifying testing for the user and enhancing reproducibility of testing.
Anna Sipitanou, Business Development Manager at Copley Scientific, comments: “After the successful launch of our new TPK™ 2100 we identified the value of transferring much of the technology across to MDIs, where recent additions to the USP chapters relating to MDIs call for a range of parameters to be controlled and monitored, like for DPIs. This need led us to the creation of BAC™ 2100 which has been designed specifically for assisting analysts to perform MDI testing in a consistent and reproducible manner, but also eases the process of moving a drug application forward by satisfying regulators with robust data reporting functions. We can see the BAC™ 2100 becoming the new benchmark for MDI testing.”
In addition to the launch of the new BAC™ 2100, a new BAC™ 2100-R is being release in parallel. This is a modified version where the flow inlet and outlets are reversed to allow for different arrangements of the test equipment to be located on the laboratory bench.