Non-destructive Moisture Determination for Lyophilization Process Development and Product Quality Testing

Lighthouse Instruments
Sponsored Content

***Live: Wednesday, Oct. 21, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST*** Non-destructive moisture determination of freeze-dried product saves valuable samples and enables efficient robust data generation supporting lyophilization cycle development and freeze-dryer qualification activities. Join this webcast to hear case study data demonstrating these applications. ***On demand available after final airing until Oct. 21, 2021***

Register free: https://www.pharmtech.com/pt_w/quality_testing

Event Overview:

Determining the residual moisture content of a lyophilized pharmaceutical product is important for several reasons. First, the amount of residual moisture content is related to the stability of the formulation over the shelf life of the product. Second, moisture analysis of a statistically relevant sample set can give insight into the freeze-drying process itself.

Residual moisture determination can be used as a tool in process studies to confirm the efficiency, consistency, and robustness of a specific freeze-drying cycle that has been designed for a particular drug formulation. Unfortunately, the destructive nature of the traditional moisture determination methods (Karl Fischer titration and thermogravimetric methods) is a limitation that can lead to increased costs and limited insight into the stability and quality of freeze-dried product and drying cycles. Non-destructive moisture analysis can enable:

  • Efficient analysis of statistical sample sets
  • Ability to design and qualify drying processes in a less costly and more efficient manner based on robust statistical data
  • Ability to directly correlate moisture to other critical product quality parameters

Key Learning Objectives:

  • Learn how to use non-destructive headspace analysis for the moisture determination of freeze-dried product.
  • Review case-study data showing how the headspace analysis approach to moisture determination enables lyophilization chamber moisture mapping, efficient lyophilization cycle development, and freeze-dryer performance qualification.
  • Learn how this moisture analysis technique can be seen as a water activity measurement with general application to all dry pharmaceutical products.

Speaker: Dr. Derek Duncan, Director Product Line, Lighthouse Instruments

Time and Date: Wednesday, Oct. 21, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST

On demand available after final airing until Oct. 21, 2021

Sponsor: Lighthouse Instruments

Register free: https://www.pharmtech.com/pt_w/quality_testing