During the 21st annual microbiology conference, which was held in Oxford, UK, more than 100 attendees, speakers and suppliers contributed to lively discussions on what’s happening in the world of pharmaceutical microbiology. The meeting began with an overview of microbiology OOS investigations from a regulatory perspective by Di Morris (ex-MHRA and currently a Consultant Qualified Person). This was followed by Andrew Matthews who expanded on Di’s presentation and provided strategies for effective team investigations.
After an energizing tea and coffee break in the exhibit hall, Barbara Gerten reviewed USP <1117>, microbiology best practices, and supplementation of practical information by ISO standards. She talked about media preparation, storage and shelf life testing, quality control of media, preparation and maintenance of cultures and sample handling.
Next, attendees had an opportunity to attend one of four open discussion sessions, with topics including microbiological containment through garments, questions you always wanted to ask an inspector, rapid methods and biological indicators.
After lunch, I provided an overview of the myths and misconceptions surrounding the implementation of rapid methods. This included discussions on the impact to industry, regulations and regulatory expectations, validation, Quality by Design, changing acceptance levels and return on investment.
Edel Fitzmaurice and Julie Roberts discussed validation, verification, qualification and suitability of microbiological methods. They reviewed Ph. Eur. and USP definitions, when to validate versus verify, and provided case studies to support their recommendations.
Next, John Hutcheson provided practical considerations when dealing with biofilms in water systems. He discussed the risks to water quality, and how to control, remove and measure biofilm in these systems.
Day one closed and the gala dinner and dance began. If you have never been to a Pharmig meeting before, the social event provides for one of the best networking opportunities in the industry! And during the meeting, Dr. Tim Sandle was awarded Pharmig’s highest honors.
Day two began with Stephen McGrath’s review of objectionable organisms, compendial positions, regulatory perspectives and new emerging organisms that have caused issues within the industry.
Tim Sandle then presented examples of fungal contamination in pharma products, contamination recalls, cleanroom and operator sources, environmental monitoring and disinfectant testing.
Next, Paul Newby provided an update on the latest draft of USP <1115>, bioburden control of non sterile drug substances and products. He also shared his views on what should be considered during product development in addition to nonsterile manufacturing.
Following lunch, Simon Richards discussed microbiological issues associated with medical devices, including cleaning validation, risk management and the significance of product bioburden.
The final presentation was from Anthony Hilton, Head of Biology & Biomedical Science, Aston University. Dr. Hilton challenged the “5 second rule,” you know, when you drop food on the floor and as long as you pick it up within 5 seconds it is safe to eat? Well, for the first time, he presented scientific data on the microbiological aspects of what happens when food lands on the floor and carpet, and based on the food itself, we learned what we should be putting in our mouths and what we should avoid. A very stimulating discussion to end the meeting (and right before tea and treats)!
If you missed this meeting I would encourage you to attend future Pharmig conferences. I found the caliber of speakers, the relevant topics and networking opportunities to be among the best being offered today.