Ireland Lyophilisation Community of Practice meeting 15 November, UL

Posted on Thu, 5th December 2019

Ireland Lyophilisation Community of Practice meeting 15 November 2019, UL
After our successful initial meeting and setup of the Ireland Lyo CoP in May this year, we have met together again in UL last Friday. Thank you to all our participants from Industry and academia who were able to make it.

The Community
The day began with a welcome note from PMTC director Sarah Hayes on the Lyo CoP so far and using the CoP feedback, the group explored topics of interest for future discussion.

Eoin O’Sullivan of Astellas presented a case study on how involvement with the PMTC helped the site transition from manual to 100% automated visual inspection of a parenteral product. This case study explored the project challenges, methodology and ultimately the impact to the business both from a throughput and quality perspective this project has proven to be transformative for the Astellas site.

After the first Lyo CoP meeting, a survey of PAT use and Data in member’s processes was undertaken. Dr David Egan outlined the results of this survey to the group.

People and Training
For the Breakout session on this occasion, Training within the Lyo industry was undertaken as a substitute for the planned session on regulatory risks. Groups discussed the different training requirement of Scientists / Engineers, Production operators as well as for management. The results will be sent out to the wider group in the coming days. The objective of the exercise was to understanding the Industry needs with respect to training is that the PMTC will aim to respond by signposting and or delivering the required training and or supporting PMTC members to leverage opportunities to access Skillnets funding to deliver the required training.

Actions taken:
The group agreed to establish a core CoP group, like an acting committee or champions. Those interested please revert to David Egan. The role of the Committee will be to propose the format and frequency for engagement as well as suggested topics to be addressed by the CoP through 2020.
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