The sensitivity of drug formulations to one or more elements of their primary packaging has always been a potential problem for the pharmaceutical industry. Biologics in particular are highly sensitive, leading to a higher risk of incompatibility between them and their containers.
This potential incompatibility - and the subsequent instability of formulations - may have multiple causes such as silicone oil droplets, or to interaction between the drug and the surface of the primary container, leading to the protein aggregation phenomenon, or instead to the particles generated by the rubber in the closure system, such as plungers, stoppers, etc. or glass delamination.
Based on these considerations, Ompi decided to initiate a development project with the main purpose of creating a primary packaging platform focusing on addressing the problems associated with the interaction between drugs and their primary packaging.
The result of this development has been the EZ-fill® Alba product range, a sterile glass container platform including vials, cartridges, and syringes.
All the Alba products have the same internal treatment, based on the standard silicone oil, Dow Corning 360, which is cross-linked to the surface of the glass.
Alba treatment is a new technologythat creates a lubricant layer. This ensures that the number of silicon particles present is normally lower than on the same container where standard siliconization technologies have been used.
It simultaneously ensures high performances in terms of gliding and break-loose forces for syringes and cartridges.
Alba treatment creates a barrier between the drug and the glass that makes it possible to reduce the amount of inorganic extractables, which is a very good indicator of the container’s propensity to delaminate.
Moreover, thanks to extremely low level of particles the Alba syringe compliant with USP789, the highest standard required for containers used in ophthalmology drug products.
Finally, having the same treatment among the different primary containers used during drug product life-cycle, Alba platform is a perfect solution to de-risking the development process, saving on costs and securing a fast introduction to the market.
The components for the syringe system are selected, produced and designed to ease the functionality and compatibility of the full system
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