19/01/2020 Determination Of Moisture Permeation During Product Shelf Life

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Case Study

Determination Of Moisture Permeation During Product Shelf Life

Source: Lighthouse Instruments
Background:

Dry pharmaceutical product needs to be protected from moisture to achieve

an optimal shelf life.
Sterile injectable products such as freeze dried formulations or dry powders
are often sealed in stoppered vials under dry nitrogen.
Over the shelf life of the product it is possible for moisture to permeate into
the vial. This can be measured with laser-based headspace analysis.

Experiment: Moisture Permeation Results

Two blind sets of lyophilized product were delivered for analysis. One set was
recently manufactured and the other set had reached its end of shelf life.
Headspace moisture and oxygen were analyzed in each sample.

Conclusions:

The old and new lyo product samples were easily distinguishable using the headspace measurements.
The end of shelf life samples showed a 2x increase of headspace moisture due to permeation through and desorption from the
stopper.
The end of shelf life samples also showed a 4x increase of headspace oxygen due to permeation through the stopper.
Knowledge of the headspace dynamics over time contributes to better assessment of shelf life and could possibly drive
improvements in the primary packaging.

The LIGHTHOUSE method for non-destructive headspace analysis enables headspace monitoring over the full shelf life in a single vial.
This in turn enables very accurate determination of permeation rates of potentially reactive gases such as water vapor and oxygen during
the product shelf life. Such information can be critical for QC groups performing stability studies, or for packaging development groups
responsible for choosing the optimal primary packaging configuration.

Lighthouse Instruments
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19/01/2020 Determination Of Moisture Permeation During Product Shelf Life

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