The new Automated Emitted Dose (AED) system from Astech allows for in-line emitted dose testing of inhalers, saving time and money by generating results from the production line which determine whether full batch production should continue.
Traditionally, batch testing has been carried out in isolation, away from the manufacturing environment.
However, the AED addresses 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.
"Our system offers an increased capacity for emitted dose collections without the health and safety issues of manual testing," Anthony Moran, Astech's business development manager said.
"Variations in inhaler design can easily be accommodated by simply changing the module that loads the inhalers making it suitable for any manufacturer."
The AED collection chamber ensures accurate sample collection and recovery due to its small internal volume and unique design, the company said.
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).