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Container Closure Integrity of a Glass Prefillable Syringe in Deep Frozen Storage Conditions.

Jessica Baseggio¹, Anton Zverev², Odra Pinato¹

¹EMEA Technology Excellence Center, Stevanato Group, Piombino Dese, Italy.

Journal of Pharmaceutical Sciences

|December 9, 2023

Summary

Container closure integrity (CCI) for frozen pharmaceutical storage is challenging. A new dye ingress test and CO2 headspace analysis reveal glass prefillable syringes fail below -70°C due to plunger-barrel seal issues.

Keywords:

Container closure integrity Deep frozen storage Dye ingress Frozen drug product Prefillable syringe Primary packaging

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Freezing, Thawing, and Packaging Cells for Transport

Freezing, Thawing, and Packaging Cells for Transport

Published on: July 2, 2008

Area of Science:

Pharmaceutical packaging
Low-temperature storage science
Container closure integrity

Background:

Novel drug modalities require reliable frozen storage and transport.
Assessing container closure integrity (CCI) at low temperatures is difficult.
Current low-temperature container closure systems (CCS) are limited to vials, despite the rise of prefillable syringes (PFS).

Purpose of the Study:

To develop and validate a new low-temperature dye ingress test for container closure systems.
To evaluate the CCI of glass prefillable syringes (PFS) at deep-frozen temperatures.
To compare the new dye ingress method with an orthogonal technique for CCI assessment.

Main Methods:

Development of a novel low-temperature dye ingress test method.
Application of the dye ingress test to glass PFS across a range of deep-frozen temperatures (-50°C to -80°C).
Orthogonal evaluation using laser-based CO2 headspace gas analysis.

Main Results:

The new dye ingress method demonstrated versatility for various CCS formats and temperatures, including -80°C.
Both dye ingress and CO2 headspace analysis indicated consistent CCI failure in glass PFS below -70°C.
The primary failure mode was the plunger-to-barrel interface, linked to thermal dimensional changes and reduced elasticity.

Conclusions:

Glass PFS exhibit temperature-dependent CCI behavior, failing at deep-frozen conditions.
Thorough characterization of package integrity is crucial for deep-frozen drug products.
The developed dye ingress method offers a viable solution for low-temperature CCI assessment.