Lighthouse Instruments

Articles

Container Closure Integrity and Deep Cold Storage

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

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

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.

Dr. Derek Duncan, Director Product Line, Lighthouse Instruments

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



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

Webcasts

***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***

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

	Pharmaceutical solids can come in contact with water during processing and are susceptible to water exchange with the surrounding environment during storage. Because this can lead to adverse effects on the pharmaceutical material, it is important to characterize and control the moisture present in the material.

	Standard moisture determination methods determine the total water content. However, water activity determination is increasingly being used in the pharmaceutical industry as evidenced by a new 

draft chapter <922> Water Activity.  This new 

 chapter is motivated by the fact that a water activity measurement differentiates between tightly bound and free or loosely bound water. Free or loosely bound water is more freely available to participate in chemical, biochemical, or physicochemical reactions.

	This webcast presents how a water activity measurement can be implemented to give insight into the impact of these reactions on critical product quality attributes including stability, dissolution rate, and physical properties of tablets, pills, and capsules, and other solid pharmaceutical material.

		Learn how water activity can impact crystalline form, degradation rate, dissolution rate, and physical properties of oral solid dosage forms

		Learn the key method development and method validation requirements detailed in the new 

		See how a laser-based water activity analyzer provides rapid, accurate, and precise measurements

Mike Lally, Application and Validation Specialist, Lighthouse Instruments, LLC.

Tuesday, Oct. 22, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

	On demand available after airing until Oct. 22, 2020

The pharmaceutical industry has used Karl Fisher titration to measure total water content in oral solid dosage forms for 30-years. Learn how USP , a new compendium for water activity measurements, recommends water activity methods for providing unique data and insights into formulation development, packaging selection, manufacturing, and long-term stability of pharmaceutical solids. 
Live: Tuesday, Oct. 22, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
On demand available after airing until Oct. 22, 2020 
Register free


New Draft USP  Chapter for Water Activity Measurement

	For oxygen-sensitive formulations, the headspace gas composition in sterile pharmaceutical product containers is critical. Monitoring and controlling headspace oxygen levels throughout the product life cycle becomes necessary to determine accurate stability specifications, monitor nitrogen purging processes during filling, and to assure product stability throughout shelf life.

	This webcast presents case studies that demonstrate how laser-based non-destructive headspace oxygen analyzer platforms can replace destructive electrochemical and gas chromatography (GC) methods for the analysis of oxygen-sensitive formulations in the following activities:

 A rapid non-destructive headspace oxygen analysis method enables streamlined stability studies and saves high-value material during the development phase

 In production, laser-based headspace analyzers are implemented at-line for optimizing, validating, and controlling the nitrogen purging process

 A GxP database software solution meets strict data integrity requirements for release testing in the QC environment

		Learn how to improve the stability of oxygen-sensitive formulations

		Learn how to optimize packaging to protect oxygen-sensitive formulations

		Learn how to monitor and control filling processes of oxygen-sensitive product

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

Tuesday, Sept. 24, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

	On demand available after airing until Sept. 24, 2020

Is your parenteral drug oxygen sensitive? Non-destructive headspace oxygen analysis methods can be used to help protect oxygen-sensitive formulations throughout the product life cycle.

Live: Tuesday, Sept. 24, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST 

On demand available after airing until Sept. 24, 2020

Register free
