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Utilizing our extensive knowledge in pharmaceutical glass primary packaging, we convert your ideas into reality.
Working hand in hand with customers, we develop, manufacture and deliver a wide variety of drug containment solutions that have been designed to meet specific market needs. Improved mechanical resistance, excellent cosmetic appearance, tight dimensional tolerances, consistent surface performance and maximum device compatibility are the key aspects that define our pharmaceutical glass primary packaging product lines – Fina®, Nexa®, Alba®.
Alba® represents a best-in-class solution to address the development of sensitive biologics, such as highly concentrated drugs prone to silicone aggression and ophthalmic drugs. Medicines are particularly sensitive to all the components of the primary packaging they are in contact with, which might impair the compatibility between drug products and the container closure system.
Alba® platform comprises pre-fillable syringes and vials*, featured by a cross-linked coating technology based on standard silicone, significantly reducing potential interaction between drug product and container surface, thereby providing a superior packaging solution for sensitive ingredients. Due to the excellent properties of the layer, Alba® specifically addresses drug formulations with high sensitivity with silicone oil emulsification, drug and surface interaction, extractables, delamination and pH shift.
*Under development.
Alba® addresses some of the key requirements of silicone aggressive drugs and helps biopharmaceutical companies to reach compliance with the latest guidelines coming from regulatory bodies, such as USP <787> and <788> for parenteral formulations.
Stabilized silicone layer
Alba® ensures increased stability of the functional performances (gliding and break-loose forces), assuring an optimized drug administration through auto-injectors.
Ultra-low particles released
Alba® features an internal layer, standard silicone oil, which is cross-linked with the glass surface. Alba® prevents silicone migration, drastically reducing sub-visible particles release.
Minimized extractables
Alba® coating technology acts as a barrier between the drug and the glass, substantially reducing inorganic extractables.
Mitigated delamination risk
Alba® creates a barrier effect preventing the occurrence of pH shift and delamination.
Nexa® platform is a state-of-the-art solution when high-quality and outstanding performance are required.
Nexa® containers are superior in terms of functionality and performance compared to standard market solutions. Designed specifically for high-value drug products, Nexa® provides excellent mechanical resistance (up to three times higher than a standard container) and superior cosmetic quality. A 100% camera inspection guarantees consistent levels of quality.
Available in 27 gauge and 29 gauge, our ½” needle with a 5B tip, has an enlarged internal channel diameter to optimize the delivery of highly viscous drug formulations without the need for bigger needles. It has been designed to meet the requirements of Nexa® and Alba® performance levels in terms of dimension, cosmetics, penetration, and breakage resistance.
We have widened our syringes portfolio to include the state-of-the-art Nexa FlexTM pre-sterilized polymer syringe. Available both in COP (Cyclic Olefin Polymer) and COC (Cyclic Olefin Copolymer) material, customers can now benefit from an unmatched offering on both glass and polymer solutions.
Stevanato Group’s experience in glass processing led to the development of a higher class of containers capable of combining customer needs for customization and quality.
Fina® is the right solution when high cosmetic quality and tight dimensional controls are required. It also allows for a high degree of customization, where a fully-tailored solution is required.
The quality levels of Fina® have been obtained by optimizing the forming process with improved cosmetic and dimensional controls.
