Come early next week I will be fully ensconced in deep discussions over cleanroom environments, microbial monitoring and single-use technologies in the beautiful setting of Old Windsor in England. I may also possibly take afternoon tea with the Queen in her castle, if discussions finish early.
Why am I in Old Windsor, you ask? Because I have the great honour of being the chairman of the Sterile Manufacturing CxO Dialogue on Nov. 21 and 22, where I am looking forward to listening to presentations by a number of speakers on topics ranging from “Monitoring microbial environments” to “Moving to a disposable manufacturing operation” to “Lean manufacturing in a sterile environment.” During this time, I invite you to follow me on Twitter where I will endeavour to keep you informed with highlights and interesting outcomes from the event. I also hope to share with you in a blog next week a more detailed summary of proceedings, so watch this space.
The timing is impeccable, as the December issue of Pharmaceutical Technology Europe will contain a special feature devoted to maintaining sterility. We have brought together a diverse panel of experts to keep you abreast of current industry trends. Contributors include our resident columnist Jerold Martin who discusses the introduction of single-use systems into final-filling cleanroom environments, noting that a key strength is their recognition as “closed systems” by drug manufacturers and regulatory bodies. Neil Wesley from SCM describes how improved training can help reduce the principal source of contamination: people. Aseptic Technology’s Benoit Verjans considers the barriers to uptake of new technology, noting that much reluctance comes from the fear of regulatory rejection. Mark Dalziel from Dycem looks at the origins of airborne contamination and the risks of not successfully controlling such particles.
Considering this sudden activity in all things sterile-manufacturing related, and to garner interest and submissions for our Agent-in-place column, I have begun a discussion on our LinkedIn group where you can exchange stories or information about regulatory updates or issues with other members. If you’re not already a part of the group, you can join us here. The Agent-in-Place column distills a number of true-life cautionary tales collected each month from our readers by “Control,” a senior compliance officer. Check our archives.
And for more information about the Sterile Manufacturing CxO Dialogue, click here.