Astech Raise the Bar of Inhaler Testing

Leading automated drug delivery testing system provider Astech Projects has developed a unique, fully automated solution for the Andersen Cascade Impactor inhaler test, the Xelize^®. Using its extensive industry and automation expertise, Astech has developed the fastest and most robust system on the market which can greatly reduce time spent on labour-intensive processes and minimise errors associated with manual systems. The Astech Xelize is designed around the traditional Andersen Cascade Impactor system but can be tailored to the specific needs of the tester and device, and as a true high throughput system, can significantly improve the accuracy and efficiency of the inhaler testing and particle size determination (PSD) process.

PSD has always been considered one of the most labour-intensive of the regulatory tests for inhaled pharmaceutical products. The new fully automated Xelize is the first system anticipated to achieve a throughput of 40 Andersen impactions per day, a potential 10 fold increase over some manual methods. Astech Projects’ Sales and Marketing Director, Anthony Moran said, “Throughput is vastly improved with this system as we have moved away from the standard recovery method, i.e. one stage and plate at a time, in series. Instead we have designed the Xelize for parallel operation and recovery of all stages and plates, significantly speeding up the testing process.”

The Xelize provides high capacity storage for up to 200 devices, minimising time spent on manual load. Sophisticated device handling controlled by advanced software, allows easy and precise device manipulation and actuation, with tight control of the dose actuation parameters, greatly improving repeatability of results. Additionally, sample preparation for HPLC analysis can be fully automated avoiding inconsistencies associated with manual methods. Company-specific coating techniques for Andersen plates, such as fine film spraying, are easily accommodated and fully automated, allowing faster repetition of coating, sample capture, retrieval and analysis cycles. Additionally, sealed recovery stations improve user safety and prevent test cross-contamination.

Astech’s Xelize system with integrated software is protected by patent applications in the UK and overseas, and has been produced for both R&D and manufacturing quality control following Good Practice and Compliance for Electronic Records and Signature, Part 2, and is fully compliant with 21 CFR 11 and Good Automated Manufacturing Practice (GAMP).

The Xelize system is just one of a range of high quality automated systems produced by Astech Projects and complements its portfolio of innovative systems engineered for drug delivery testing.

For more information please click on the 'article webpage' or visit Stand #2 at Drug Delivery to the Lungs (DDL), Edinburgh International Conference Centre, December 12th -14th 2007.