Original Event Date: Tuesday, June 4, 2013
Duration: 45 minutes
Presenters: David Exline, Senior Vice President at Gateway Analytical
Host: Shawn Wilhelm, Marketing Coordinator at Gateway Analytical
Highlighted Topics Covered:
- Examples of commonly found contaminants in inhalable drug products
- How these contaminants are introduced into the manufacturing process
- A basic multi-tiered analytical approach to characterize foreign particulate matter
- How to solve particulate contamination issues in inhalable drug products using a scientific approach.
- The importance of taking a pro-active approach to quickly source and manage contaminant issues in the manufacturing process to reduce the risk of future contamination
The overall objective of a solid quality foundation in the evaluation of particle contamination analysis of inhalables is based on many things. The complete evaluation and root cause analysis of foreign particulate matter, as well as the affects of particulate on product quality, are essential when evaluating the processes for developing and implementing an inhalable product. In addition, a methodology for determining acceptable limits and methods for ensuring product quality must be evaluated early on in the development process to ensure the best end product. Finally, the analytical methods utilized to test particulate and determine the particulate source are critical in the success of any testing program.
This webinar was designed for individuals involved in the manufacturing of inhalable drug products, including quality control, optical inspection and process development/engineering personnel. During this webinar, our presenter provided examples of commonly found contaminants in inhalable drug products and how these contaminants are introduced into the manufacturing process. He presented to the audience a basic multi-tiered analytical approach to characterize foreign particulate matter and how to solve particulate contamination issues in inhalable drug products using a scientific approach. The importance of taking a pro-active approach to quickly source and manage contaminant issues in the manufacturing process to reduce the risk of future contamination was also discussed.
David Exline, Senior Vice President
David Exline has more than 18 years of experience in managing and administering analytical laboratory and consulting services. Mr. Exline has helped companies establish cGMP laboratories and assisted pharmaceutical drug manufacturers to ensure that their cGMP facilities are compliant with FDA regulations. He is adept in numerous pharmaceutical-related services and testing methods including: materials characterization, particulate contamination analysis, particle sizing and high-resolution microscopy.Although familiar with analytical practices in several industries, Mr. Exline’s expertise lies in the pharmaceutical, materials science and forensic realms.