Lighthouse

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.

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

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.

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.

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.


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.




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.

Webcasts

Webinar Date/Time: Wed, Mar 13, 2024 11:00 AM EDT




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

Learn practical steps to achieve compliance to the container closure requirements in the new EU GMP Annex 1.

https://www.pharmtech.com/pt_w/practical-road-map

The new EU GMP Annex 1 contains new requirements for the container closure of sterile pharmaceutical products. These requirements will trigger new best industry practices in the area of container closure integrity. This webinar will review the new requirements and describe a practical road map enabling compliance:

Implement a deterministic analytical method for container closure integrity testing.

Such a method enables generation of robust science-based packaging data as required by the new Annex 1.

Design packaging studies which a) demonstrate the achievement and maintenance of good container closure, and b) enable the design of an appropriate testing strategy.

Learn how to interpret the new container closure requirements in the new EU GMP Annex 1.

Understand how to develop deterministic analytical methods for container closure integrity testing.

Understanding how to design packaging studies that generate robust science-based data demonstrating good container closure integrity.

Manufacturing representatives responsible for compliance to the EU GMP Annex 1

QC representatives responsible for container closure integrity testing

Packaging and process development representatives

 began his career at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He moved into industry holding Product & Application Development positions. Currently 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, lyo chamber moisture mapping, and automated media fill inspection.



Webinar Date/Time: Tuesday, April 4th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST


A Practical Road Map for Compliance to the Container Closure Requirements in the New EU GMP Annex 1

Live viral vaccines and gene and cell-based therapies sometimes require deep cold storage temperatures (-80 ˚C down to cryo) to maintain the activity and efficacy of the formulations. Studies have shown that these deep cold storage temperatures can introduce risk to the sealing performance and container closure integrity (CCI) of the packaging components.

An introduction to the effects of deep cold storage on CCI

How robust development work can be done in a holistic framework to choose the appropriate packaging components and to qualify the sealing process such that the risk of CCI issues during deep cold storage and transport is minimized.

Gain insight into the risk to container closure integrity (CCI) during deep cold storage.

Identify appropriate analytical tools, to generate robust data to characterize and mitigate the risk to CCI.

How the generation of robust data will enable you to perform proper risk assessments and design risk mitigation strategies.


Director Product Line
LIGHTHOUSE Instruments BV


Dr. Duncan began his career at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He moved into industry holding Product & Application Development positions. Currently at LIGHTHOUSE since 2003, Dr. Duncan is responsible for developing applications for process monitoring and finished product inspection.

Thursday, October 21, 2021 at 4pm CEST |10am EDT| 7am PDT| 3pm BST
Protect not only your valuable product but also public health by ensuring correct storage choices.  Gain insight into the effects of deep cold storage and a holistic approach to ensure Container Closure Integrity of sterile pharmaceuticals. 

Container Closure Integrity of Product Requiring Deep Cold Storage

Articles


• Container closure integrity testing is vital for sterile injectable products.
 

• The Headspace Gas Ingress method is a robust detection method of critical leaks.
 

• This method is an upgrade to the blue dye test and can be scientifically validated.