Issue link: http://www.e-digitaleditions.com/i/579724
measured manually. Switching to surrogate tech- niques, the throughput is several tens of times that of existing, commercially-available robotic impactors, and hundreds of times that of fully-manual impactor use. However, work flow may be increased with existing commercial systems by utilizing fewer stages to gain speed, e.g., by using a two-stage impactor or the Alberta Idealized Throat plus filter or an abbreviated impactor. While the present system and one of the robots are fully automated and deliver either the data or vials ready for analysis, another automated system requires manual work, mainly the handling of the inhaler device. The speed of the present system relies on the use of surrogate parameters, e.g., delivered mass instead of delivered dose or the applicability of laser diffraction for particle size measurements instead of impactor work. The type of inhaler being tested will impact the testing methods available for simplification, as will acceptance by author- ities who determine the success of this quickly develop- ing field of test automation. Conclusions Automated testing is close to ideal for the investigation of consistency and reliability of inhalers and other devices. The robotic system presented here is mainly suited for development purposes because of its designed- in flexibility. Based on its data, inhaler design decisions can be made with greater certainty. As a next step, ele- ments (e.g., modules) of this robot can be transferred to production and may be implemented as process analyti- cal technology, where only a high throughput test sys- tem can provide the necessary testing robustness at an affordable cost. Acknowledgements Part of this work was been presented at RDD 2014 in Puerto Rico, US. Frank Richter's and Andree Jung's contributions to the continuous improvement of the system are gratefully acknowledged. References 1. Gregory Weddle. (2004), Validation Requirements for Building Automation Systems, [https://www.johns oncontrols.com/content/dam/WWW/jci/be/commer cial/capabilities/my_building__vertial/life_sciences/arti cles_and_white/BAS_Validaion_White_Paper.pdf]; Accessed Nov 30, 2014. 2. 21CFR11; Revised as of April 1, 2014; Electronic Records; Electronic Signatures, Revised version avail ble: [http://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfCFR/CFRSearch.cfm?CFRPart=11&showFR =1]. Accessed Nov 30, 2014. 3. Ian Carter, Stephen Lawlor and Malcolm Smith; Addition of an Automated Impactor Leak Test Func- tion to Novi Ictus Automated Aerodynamic Particle Size Distribution Robots to Improve Data Quality; [http://www.aerosol-soc.org.uk/files2/DDL17- 2006/11.Carter.pdf]; Accessed Nov 30, 2014. 4. Paolo Florini and Debora Botturi; Introducing Ser- vice Robotics to the Pharma Industry; Intelligent Service Robotics Journal, Vol. 1, March 2008, 267-280. 5. ICTUS, Automated Andersen Impactor Measure- ments. [http://www.novi.co.uk/inhaler-testing/ictus/]. Accessed Nov 30, 2014. 6. NGI-SRS, Sample Recovery System. [http://www. copleyscientific.com/editorials.asp?c=116&d=3]. Accessed Nov 30, 2014. Further reading • David A. Vogel, Kevin J. Barnes; Ideas for Validating Production Software-High Risk Production Software Doesn't Always Need an Elaborate Testing Program; Medical Design, September 2005. • Kimberly S. Cleaves; Automating R&D; Modern Drug Discovery, June 2004, 37-39. • Nigel North; Implementation of analytical technolo- gies in a pharmaceutical development organization– looking into the next millennium; Journal of Auto- mated Methods and Management in Chemistry, Vol. 22, No. 2 (March-April 2000), 41-45. • Satoshi Saitoh and Takayuki Yoshimori; Fully Auto- mated Laboratory Robotic System for Automating Sample Preparation and Analysis to Reduce Cost and Time in Drug Development Process; Journal of Labo- ratory Automation, Vol. 13, 2008, 265-274. • Alain Bultink and Roger Neville; Regulated Comput- erised Systems – Risk Assessment; Whitepaper [http://www.pstestware.com]; 2006. • Jolyon Mitchell and Mark Copley; Accelerating Inhaled Product Testing, http://www.pharma- mag.com, January/February 2010: 14-17. Available at [http://www.copleyscientific.com/files/ww/news/CO P%20JOB%20098_Accelerating%20inhaled%20pr oduct%20testing.pdf]; Accessed Nov 30, 2014. • 21 CFR Part 11 Compliance for MS Access Databases. [http://www.part11solutions.com/cfr/solutions/access .asp]; Accessed Nov 30, 2014. Herbert Wachtel, PhD is a Senior Principal Scientist in Analytical Development at Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Str. 173, 55216 Ingelheim, Germany, Tel.: +49 (6132) 77-98552, herbert.wacht el@boehringer-ingelheim.com, Website: www.boehringer- ingelheim.com. 20 OCTOBER2015 Inhalation