Newsletter | September 8, 2021

09.08.21 -- Considerations For Moisture Analysis In Lyophilized Pharmaceuticals

Headspace Moisture Analysis For Determination Of Residual Moisture Content in Lyophilized Pharmaceutical Products

Headspace moisture analysis is a rapid nondestructive analytical method that addresses the limitations of traditional methods used for residual moisture determination. Learn how rapid nondestructive headspace moisture determination enables the generation of data for product life cycle activities related to lyo cycle optimization, lyo chamber moisture mapping, freeze dryer qualification, formulation development, and product stability studies.

Comparing Methods For Residual Moisture Analysis Of Lyophilized Products

The residual moisture content after freeze drying is a critical product parameter that should be optimized per product formulation and, ideally, a residual moisture determination method should be available for these activities that enables efficient analysis of statistical sample sets. This article explores the different analysis techniques that can be used to determine the residual moisture levels of freeze-dried product.

Lyo Chamber Moisture Mapping

The applications of headspace moisture analysis take advantage of the fact that it is straightforward to analyze the headspace moisture content of all vials in a statistically relevant sample set. Rapid nondestructive headspace moisture analysis enables fast moisture determination of statistical numbers of lyo samples.

Moisture Headspace Analysis For Efficient Scale-Up Of Freeze-Drying Capacity And Validation

A vaccine production facility needed to replace an old freeze dryer in an existing facility during running operations. Activity involved a scale-up of freeze-drying capacity from 14 m2 to 28 m2. With the application of nondestructive headspace moisture analysis, small-scale proof-of-concept studies were used to minimize project risk and the number of full-scale runs in the freeze-drying validation process.

FMS-Moisture/Pressure Headspace Analyzer

The FMS-Moisture/Pressure is a nondestructive headspace moisture and pressure analyzer from LIGHTHOUSE, the industry leader in laser-based headspace analysis. The compact benchtop instrument utilizes a patented laser absorption technique developed with funding from the Food and Drug Administration. This rapid and versatile technology addresses a wide range of applications that span the full product life cycle.

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