Automated inhaler tester accommodates any design
The new Automated Emitted Dose (AED) system introduced by UK company Astech Projects addresses both the demand for in-line high throughout inhaler testing as well as all variations in device design.
The new Automated Emitted Dose (AED) system introduced by UK company Astech Projects addresses both the demand for in-line high throughout inhaler testing as well as all variations in device design.
Used to verify consistent dose delivery, this modular and scalable AED system incorporates sophisticated software for random sample collection, analysis and tracking using bar code technology.
Traditionally, batch testing has been carried out in isolation, away from the manufacturing environment. However, Astech's AED system could could provide a time- and cost-efficient alternative by allowing in-line emitted dose testing where results generated from devices picked off the production line would determine whether full batch production should continue.
The small internal volume and unique design of the AED collection chamber ensures accurate sample collection and recovery due, the company says. The active pharmaceutical ingredient can be recovered using as little as 25ml of solvent, even after rinsing. The AED system also incorporates a fully automated HPLC vial collection module with capacity for up to 400 HPLC vials.
Advanced software allows tight control of the dose actuation parameters including number of doses, device weighing, duration between shots and actuation speed. Dose firing parameters and device performance checks are also controlled in this manner.
The AED system with integrated software has been produced for both r&d development and manufacturing quality control following Good Practice and Compliance for Electronic Records and Signature, Part 2 and is fully compliant with 21 CFR Part 11 and Good Automated Manufacturing Practice (GAMP).
"Our system offers an increased capacity for emitted dose collections without the health and safety issues of manual testing," said Anthony Moran, Astech's business development manager. "Variations in inhaler design can easily be accommodated by simply changing the module that loads the inhalers making it suitable for any manufacturer."