Case Study

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.

access the Case Study!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Pharmaceutical Online? Subscribe today.

Subscribe to Pharmaceutical Online X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Pharmaceutical Online