Blogs

Development of vaccines for COVID-19 and its variants continues to present challenges such as accelerated timelines. Since there is not the usual time available for selection, evaluation, and qualification of the package and delivery systems, risks must be mitigated at every phase. For vaccines packaged in prefilled syringes, use of an elastomer plunger laminated with FluroTec^® film can help.

Beginning in 1998, when an increase in the incidence of pure red cell aplasia (PRCA) was observed in patients with chronic renal failure and associated with the subcutaneous use of Eprex^® (epoetin alpha), the U.S Food and Drug Administration (FDA) and European regulatory agencies have paid special attention to leachables in drug products especially resulting from uncoated primary elastomer components.