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.