Module 3 2019

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?

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The Organisation for Professionals in Regulatory Affairs