Following on from Day one, for the second day of the conference, the speakers had a tough act to follow!
Steve Ward was up next, Ward is a Consultant for T-SQUARED Validair, as well as being Chair of LBI/30 Cleanroom Technology BSI committee and acting as UK technical expert for ISO/TC209 Working Groups 3, 4 and 7 (updates to ISO 14644-3, 14644-4 and 14644-7). Ward used his talk to discuss a new important term making the rounds in airflow testing; “source strength”. His talk covered when air change rates are relevant, but also, when they are not. Sometimes a high air change rate doesn’t help, and Ward explained: “What you don’t want is air moving very quickly and to other parts very slowly.”
Dennis Smeijer, Business Unit Director Cleanroom at cleanroom laundry expert ELIS, then delivered a talk on achieving the Annex 1 objective of 0 CFU in grade A manufacturing using correct gowning regimes. With regard to what has changed with Annex 1, Smeijer emphasised timing and socks. “We know that cleanroom socks are now in focus in Annex 1. It is no longer compliant to wear your outside socks,” he explains. But he also reminded the delegates that "It is not just about what you wear, it’s about when”.
We know that cleanroom socks are now in focus in Annex 1. It is no longer compliant to wear your outside socks
Ulrich Dudel, Senior Engineer Front End Design at Pharmadule Morimatsu, gave a talk covering process flexibility through modularisation in drug manufacturing. A fascinating trend in the cleanroom sector for many of the delegates involved with drug production.
Switching gears to a contamination control case study, Morgan Polen, a microbiology consultant for Microrite, walked the delegates through every step of trying to get a cleanroom compliant. He discussed data integrity, fungal contamination, macro particle sampling and smoke studies. “Smoke studies revealed problematic air patterns, facility design flaws, and facility maintenance issues,” Polen explained. Two different problems he identified were short circuits in airflow patters and decoupling RABS from cleanroom HEPA filters. The fascinating case study was a highlight of the day for the attendees, with videos and photos showing everything discussed.
There is a lot of news online about ISO 14644-21, but this is not published yet
Tim Triggs, the Day one chair, then spoke about filter leak testing, airflow measurement and particle counting. He explained that cleanroom testers can be certified either by associate level or professional level, an interesting concept for the delegates. Training is something that needs to be understood to make sure the staff you have know what they are doing.
Conor Murray then gave a talk about new developments in microbiological monitoring, specifically talking about RMM and Annex 1.
LWS’ Solmaz then gave a talk about the other side of monitoring; particles. Solmaz specifically spoke about the new ISO14644-21. “There is a lot of news online about ISO 14644-21, but this is not published yet,” he said. Giving the delegates the warning to keep their eye out for it!
The day finished up with another new addition to the conference… the Exhibitor Showcase! This entails 20 exhibitors from the conference giving a 30-second round-up of what they do. Leaving the delegates with a good roundup of what there is on offer to help them reach their contamination control goals!
Looking ahead to 2024, Cleanroom Technology Conference will certainly be back in Singapore! The enthusiasm of delegates and exhibitors alike has been a great joy to see, and is already getting us excited to be back!
