Prefilled Syringe Testing
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Abstract
Prefilled syringes are used for many therapeutic biologic formulations, and are a good option for ophthalmic injections that require very low volumes of the drug product. They are useful for biologics and other expensive drug products because the overfill volume for the syringe is much lower than the volume required for products filled into vials. Another advantage of a prefilled syringe is their ease of use. They are suitable for self-delivery by the patient and reduce the risk of contamination when compared to the multiple steps required for withdrawing a dose from a vial. They are, however, challenging to manufacture with respect to filling, sealing, inspecting, and conducting testing that is specific to the primary packaging.
STEMart provides manufacturers of prefilled syringe with the leading programme for comprehensive design validation testing, including all aspects of the relevant ISO syringe standards plus usability studies and measurement of bio-availability.
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