Attend this innovative webinar introducing the new USP<922> general chapter that provides a clear regulatory justification for implementing water activity testing. Water activity measurements provide a comprehensive understanding of the root cause of the chemical, physical and microbial changes that can cause product stability failures.
There is strong scientific evidence to document that water activity rather than total water content is the variable that impacts multiple critical quality attributes (CQAs). This webinar includes published studies that show how elevated humidity increases the water activity of tablets and capsules that are packaged in bottles and blister packs. As the relative humidity inside the primary packaging increases, the water activity of the product increases. It is this increased water activity that will drive chemical degradation reactions, impact the dissolution rate and create an environment where microbial growth can all create product quality failures.
Join this webinar to get insights on how implementing the USP<922> water activity testing during the formulation development, process development and packaging selection projects will help optimize the selection of excipients, process conditions and primary packaging materials.
Mike Lally, Application & Validation Specialist, Lighthouse Instruments
For the past decade, Mike Lally has worked with pharmaceutical research, manufacturing and QC groups who have implemented water activity testing into their quality programs. Prior to joining Lighthouse Instruments, Mike had 30 years of experience in analytical and preparative HPLC. Mike received his BSc in Chemical Engineering from Arizona State University.
Who Should Attend?
This webinar will appeal to professionals in the following fields:
- Formulation development
- Process development
- Packaging development
- Stability testing
- Microbial limit testing
- Quality control
- Regulatory affairs
What You Will Learn
Attendees will gain insights into:
- Learn it is water activity not total water content that correlates to the quality and stability of oral solid dose pharmaceuticals
- Water activity provides data that traditional Karl Fischer titrations cannot supply, and therefore provide valuable insights into your CQA
- Water activity testing is now a compendium method, and the data should be included in all regulatory filings
LIGHTHOUSE is the leading global provider of laser-based headspace analysis systems and measurement services. Headspace applications include container closure integrity testing, monitoring of headspace oxygen during filling and for stability studies, water activity determination, lyo cycle optimization and chamber moisture mapping, and automated media fill inspection. LIGHTHOUSE offers a range of benchtop and in-line platforms with patented laser sensor technology commercialized with the help of funding from the Food and Drug Administration. In addition, analytical services are delivered from laboratory facilities in Amsterdam and Charlottesville, Virginia and include method development and analytical process and product studies.