Coated primary glass containers families: a shortcut solution to reduce time to market for biotech drugs
Pharmaceutical market requirements are increasing due to regulatory pressure for higher standard in safety and integrity of drugs and the rising of new drug delivery system.
This is affecting directly the existing glass prefillable syringes characteristics and functionality even if the request is to not introduce new materials of contact between the drug and the primary packaging.
This paper is illustrating a new generation of high performances syringes as outcome of a manufacturing process that guarantees optimized dimensions and tolerances for autoinjector compatibility, low tungsten level and high cosmetic quality.
These characteristics are taken to the next level thanks to the application of a specific silicone oil based internal coating, which leads to an extra low particle level, reduced extractable and leachable, limited pH drift and very good functional performances.
A methodical approach including a precise selection of rubber closures guarantees the creation of a full system able to answer to the need of low particles and best in class performances.
These characterization allows to define the best choice of syringes suitable for the new high-demanding drugs, avoiding issues related to the interaction between the product and the primary container, thus entering on the market in a definitely shorter time than usual.