Keeping up to date with current topics and developments in microbiology
The annual Pharmig conference took place at the Nottingham on the 25th and 26th November 2016. For those who haven’t been to this event it is a mix of presentations by leading industry figures and open discussion sessions covering the latest “hot topics” where delegates can share experiences and discuss the latest regulatory information. There were also a large number of trade stands selling everything the pharmaceutical microbiologist may require.
Cherwell Laboratories were well represented, Andrew Barrow and Sandra Hulme on our trade stand, Harshad Joshi and myself - on only my third day working for Cherwell Laboratories representing us as delegates looking to expand our knowledge. Our MD Andrew Whittard was also present making sure we all behaved ourselves (he was on the stand also)! Quite a start to my life as the new Microbiology Product Specialist.
There were seventeen talks, in the interest of keeping this blog entry concise I won’t cover them all. Of interest to me personally from my production background there were talks on the operating of aging facilities - how they change with age and how to ensure they continue to comply with current regulatory requirements. To ensure they do comply, a robust environmental monitoring program is essential. The control of biofilms was also a fascinating topic of which I have seen the consequences first hand so could fully sympathise with manufacturing facilities encountering that problem.
From the perspective of my new role the talk about Environmental Monitoring and the Lean approach from Tim Sandle of the UK Bio Products Laboratories was extremely informative. This included advice on how to choose environmental monitoring locations based on HACCP and using the lean approach to reduce the number of settle plates used in lower grade cleanrooms based on data analysis from that cleanroom.
From a regulatory perspective, Andrew Hopkins, senior GMP inspector from the MHRA bookended the conference with talks about data integrity and proposed updates to Annex 1 of the EU GMP guide. Annex 1 is being updated to incorporate new and emerging technologies, to educate emerging countries where knowledge has not evolved due to lack of experience and also for areas not currently covered such as media fills, new BFS (Blow Fill Seal) technologies and closed systems.
On the stand we displayed a wide range of our plates in many different combinations of packaging, a wide range of bottles, vials and ampoules, the SAS Duo 360 and Isolator air samplers plus a rolling video of the Minncare Dry Fog 2 system for the decontamination of cleanrooms. As I write this Andrew Barrow is dealing with the many queries and potential orders received during the two days.
A mention as well about the gala dinner which took place on the evening of the first day. It is quite amazing how much you can learn from your peers over a few drinks in a relaxed environment!
This is my first blog for Cherwell Laboratories. I hope you found it useful and informative. If you have any suggestions for content we are always open to feedback, so please get in contact. Equally if you like what you read, please feel to comment.
Microbiology Product Specialist,
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?