It was great to attend our first conference of the year, The Cleanroom Technology Conference, over 25th and 26th May. The conference was solely for those that could physically attend and was not a hybrid that offered attendance virtually, as it was the previous year.
This provided a larger attendance of delegates compared to the previous year, that wasn’t as well attended, due to obvious reasons. Not only were there more attendants, but there was a positive and interactive atmosphere around the conference hall, with people really enjoying the discussion with exhibitors and the presentations being delivered.
The agenda largely focused on Annex 1, with the final version rumoured to be released by the end of the year with only a short time for the industry to become compliant. One presentation - Annex 1 and its impacts on innovation and new technology adoption, by Edward Webber from Microgenetics, discussed the impact on innovation and new technology as Annex 1 has written in a component that encourages the GMP industry to consider new technology for the future. This looked at continuous bioburden monitoring for facilities, as part of the continuous monitoring in the new Annex 1. The presentation included the identification of challenges such as the 14-day sterility test, where possible technologies and better environmental monitoring can aid in the more rapid release of product.
Contamination Control Strategy (CCS) was also a hot topic driven by proposed changes in the new Annex 1; where there should be an understanding of the environmental risk across product, process, and facility, having a more holistic view and approach, and where the EM influences or provides information that can be used as part of your CCS.
In all, the 2 days were a great success with good attendance and relaxed interaction, without the concerns of COVID preying on the mind, it was something to be considered as normal. The experience I hope will be replicated not only in the next Cleanroom Technology Conference but also in other conferences to come.
The Environmental Monitoring Processes and Validation Guide
Understand the key changes and challenges of the EU GMP Annex 1 draft revision.
What will it mean for your environmental monitoring processes?