The Board of the ECA Visual Inspection Group published a new position paper on leak testing of sterile containers. The background is the growing uncertainty among pharmaceutical companies, how to proceed with the integrity testing of sterile containers in the future. The number of companies preparing for a 100% testing, as already required for ampoules, is increasing. Frequently, however, it is overlooked here that a 100% testing does not mean 100% security if the underlying concept is not consistent. So, at first a new 100% testing leads to new questions, such as: what is tight? What kind of cracks or leaks must be detected? How do artificial leaks correlate with the risk of microbial contamination? And how can these be generated reproducibly? Also, the question of whether a high voltage lead detection is really a deterministic testing is still under discussion.
The new ECA paper is in line with the current requirements of the European Pharmacopeia and reflects the current industry practice. The paper will also be presented at the upcoming event of the group from 10-12 October 2017 in Vienna, Austria. It is planned to develop the position paper to a Guideline and also to get feedback from the group members and the US USP. The developments of the EU Annex 1, which is currently in the process of revision, will also play a role.
Members of the ECA Visual Inspection Group can download the paper free of charge on the ECA Visual Inspection Group website.