Advanced features include a fully automated in situ cascade impactor leak testing function and extensive data reporting capabilities
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 two 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, 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.