Nitrogen Purging Process Development For Oxygen Sensitive Formulations In Pre-Filled Syringes

A new biological product, in pre-filled glass syringes, had demonstrated oxygen sensitivity in stability studies. Therefore, the headspace was purged with nitrogen during filling, and the client wanted to validate the batch production process and assess the nitrogen purge efficiency. As part of their manufacturing control strategy, the client decided to generate as much data as possible before commercial launch by performing a 100% inspection on the engineering batches using non-destructive headspace oxygen analysis. In this study we demonstrate how rapid and non-destructive 100% headspace inspection can be used to generate statistical product and process data of finished product.