Application Note

Correlating Stopper Height To Container Closure Integrity

By Qianru Zuo


Gain a thorough understanding of how to comply with EU Annex 1 Section 8.28. Which information guides you in establishing the parameters for your automated raised stopper height platform?

The EU Annex 1 Section 8.28 emphasizes the necessity of having "appropriately qualified, automated methods for stopper height detection" for aseptically filled sterile products capped under Grade A air. To qualify these automated systems, it is imperative to generate data that correlates stopper height with the probability of compromising container closure integrity. Here, we describe a typical raised-stopper investigation and demonstrate how to generate scientifically robust data using headspace analysis to allow for the qualification of an automated stopper position sensor with a suitable height reject limit.

access the Application Note!

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