Module 3 Presentations

07/05/2024

Example: Pre-Filled syringe

Is a light protection required? Is the permeability appropriate? Are there any interactions with the glass or rubber materials?

 Sorption of drug components into the materials?

 Diffusion of material components (e.g. additives) into the drug?

 Are there any reaction products? Are there any influences by the silicone oil used for rubber lubrication? Are the packaging materials safe? Is the break-loose/gliding force acceptable for the intended use? It container closure integrity ensured? Is sterility ensured, even after air transportation? …

The Organisation for Professionals in Regulatory Affairs

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Suitability of a container closure system

Potentially the container closure system is able to modify the properties of a drug product (quality  efficacy  safety), therefore it is an important part of the drug product.

The Organisation for Professionals in Regulatory Affairs

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