A Rapid Non-destructive Approach for Moisture Determination of Lyophilized Product

The new USP <922> Water Activity chapter recommends certain techniques for improved moisture determination of dry pharmaceutical product. This webinar will cover practical case studies demonstrating how rapid non-destructive headspace moisture analysis can generate statistical science-based moisture data in various product life cycle activities involving freeze-dried pharmaceutical product.

Register Free: https://www.pharmtech.com/pt_w/moisture-determination

Event Overview:

Traditional moisture analysis techniques for pharmaceutical lyophilized product employ gravimetric or Karl Fischer (KF) titration methods. The new USP <922> Water Activity chapter recommends other techniques for improved moisture determination of dry pharmaceutical product. Residual moisture content, often defined as a critical quality parameter for freeze-dried pharmaceutical product, exists in different forms. Only the relatively “free” in contrast to the more “bound” water is capable of inducing degradation events within the product. However, the traditional moisture analysis techniques are unable to distinguish between the different water states. Furthermore, these methods are time intensive, involve chemical reagents, and destroy the sample, limiting their utility to generate statistically relevant data. Laser-based headspace analysis measures the water vapor partial pressure in the product container headspace, providing a measure of the thermodynamic activity of the “free” water in the pharmaceutical sample. This webinar will describe practical case studies demonstrating how rapid non-destructive headspace moisture analysis can generate statistical science-based moisture data in various product life cycle activities involving freeze-dried pharmaceutical product.

Key Learning Objectives:

• Learn how water activity measurements using laser-based headspace analysis can be used for lyophilization cycle optimization, lyophilization chamber moisture mapping and validation, and for QC moisture testing of lyophilized pharmaceutical products.
• Learn about the key method development and method validation requirements detailed in the new USP <922> Water Activity chapter.
• Understand how a laser-based water activity analyzer provides rapid, accurate, and precise measurements in a non-destructive manner.

Who Should Attend:

• Scientists and process engineers responsible for developing, optimizing, and validating lyophilization cycles.
• Formulation development scientists who select excipients and develop the freeze-dried formulations.
• QC lab scientists responsible for implementing and validating moisture determination methods.

Speakers:

Derek Duncan, PhD
Director
Lighthouse Instruments

Dr. Derek Duncan began his career at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He moved into industry holding product & application development positions. Having been at LIGHTHOUSE since 2003, Dr. Duncan is responsible for developing applications for process monitoring and finished product inspection. These include using headspace analysis for 100% container closure integrity testing, lyophilization chamber moisture mapping, and automated media fill inspection.

Paula Bracco, PhD
Sr. Study Manager
Lighthouse Instruments B.V.

Dr. Paula is a chemist with a PhD in biotechnology, responsible for the Analytical Service laboratory in Amsterdam, its analysts and customer projects. In her role, she designs studies and manages part of the customer portfolio within Europe, including pharmaceutical companies and packaging suppliers. Paula has particular interest in research and development projects for customers and, in particular, involving moisture determination by headspace water activity analysis.

Register Free: https://www.pharmtech.com/pt_w/moisture-determination