20-22 September 2022
Members of the ECA Visual Inspection Board have finished their work on a position paper regarding Container-/Closure-Integrity testing. The new document discusses leak testing of sterile containers and has been released as the uncertainty in the pharmaceutical industry increases, how integrity testing has to be handled in the near future. There is already a number of companies preparing for a 100 % integrity testing, which is already a must for ampoules. But the testing of 100% of a batch does not give a 100% security. It is much more important that the concept of testing is adequate. For example a 100% testing does not answer the question, what tight is, or how tight a container should be. Another question should also be answered, before a testing is done: What kind of leaks or cracks should be detected. And how do artificial leaks correlate with the risk of microbial contamination? As the 100% testing method must be validated, it should also be clear how artificial wholes or cracks can be made in a reproducible way.
The new ECA paper complies with the requirements from the European Pharmacopeia and reflects current industry practice. It will be further developed to a guidance and it will also be harmonised it with the US Pharmacopeia. Further, relevant changes possibly necessary due to the new EU Annex 1, which is under revision at the moment, will also be addressed. The paper will be presented at the upcoming event of the ECA Visual Inspection Group, 10-12 October 2017 in Vienna.
The new paper can be found in the download section of the ECA Visual Inspection Webpage.