Each May the microbiology society Pharmig organizes a meeting in Ireland on the subject of pharmaceutical and healthcare microbiology, drawing on a mix of international experts and audience participation to enable current topics to be debated and discussed, centered on the safe manufacture of medicines and the importance of meeting regulatory standards. The 2019 conference was chaired by David Keen, who specializes in contamination control and who works for the company Ecolab, and it took place at Portmarnock Hotel & Golf Links, Dublin.
The first presentation was delivered by Andrew Hopkins, who is the Director, Operation Quality, QA Audit and Compliance, AbbVie (and a former medicines inspector at the MHRA). Hopkins looked at the developed of sterile product manufacture guidance and the importance of developing a contamination control strategy. While the concept of a contamination control strategy is not new, the importance of a holistic approach to reducing all forms of contamination is now clearly being spelt out in regulatory guidance documentation. In the presentation it was emphasised that such a document needs to be a ‘living’ document, one that is frequently revised and added to through a review of any changes made to the manufacturing process.
The second presentation of the day was delivered by Tim Sandle (Pharmig) and it focused on the microbiological aspects of cleaning validation. Most cleaning validation strategies look at the ability of a process, through the combination of chemicals and rinses, to remove chemical contamination. Sandle’s presentation looked at the more overlooked area of microbiological risk, especially the risk that time introduces. The longer a process is held for, especially where soil (such as protein) is present, the greater the risk there is of microbial proliferation and the harder it becomes to remove these microorganisms due to the phenomenon of irreversible attachment where extracellular products are excreted and biofilms are formed.
The third talk of the day came from Donald C. Singer, who is a Senior Fellow at GSK and a member of the United States Pharmacopeia Microbiology Expert Committee. The presentation looked at the latest developments related to the committee cycle in terms of microbiology.
Here new guidance chapters are emerging on the testing of bacterial endotoxins (which can cause pyrogenic reactions) and for prions (folded strands of protein that can cause fatal neurodegenerative diseases). Singer also introduced the new monograph on the testing of the bacterium Burkholderia cepacia, which is an objectionable organism that most often causes pneumonia in immunocompromised individuals with underlying lung disease.
Interspaced between these presentations were open forum sessions, allowing the delegates to discuss matters of microbiological interest (chaired by David Keen), rapid microbiological methods (chaired by Edel Fitzmaurice), and bacterial endotoxin (chaired by Tim Sandle).
These sessions led into the fourth presentation of the day, which was delivered by consultant Tony Mayall, who looked at hygienic design in pharmaceutical facilities for manufacturers of both sterile and non-sterile medicines. Mayall looked at common design pitfalls, such as the use of ball-valves (which hold contamination) and dead-legs in pipework which slowdown water velocity and affect turbulence, leading to an increased risk of microbial adhesion.
The fifth presentation was delivered by Sinead Cowman of Lonza, and it looked at digital methods for handling laboratory data so that trends can be detected and problems reacted to before they become adverse events. The importance of data security and data integrity featured strongly in the presentation, including a warning about common software (such as Microsoft Excel) which cannot be easily validated. The emphasis was placed on purpose designed digital laboratory data capture and analysis software packages.
The sixth presentation came from Gordon Farquharson, who is a consultant specializing in cleanrooms and pharmaceutical engineering. Farquharson looked at the importance of understand the science that underpins many of the activities that take place within pharmaceuticals and how this can sometimes be overlooked, leading to myth emerging which are not based on empirical evidence. Several examples were drawn relating to aseptic processing. Farquharson stressed the importance of using barrier technology to product products from contamination, and ultimately patients.
The final presentation of the day was from David Keen and this looked at nudge theory and how this can help to reduce human error and to encourage good operator practices. Starting with examples drawn from wider society, Keen moved on to look at how operators can contaminate healthcare products through becoming distracted or through boredom. Thinking about how people move and act, and keeping them engaged were among the examples put forward to help to reduce human error.
The key messages from the day, which focused on the latest issues being flagged by pharmaceutical regulators like the U.S. Food and Drug Administration (FDA), were the need to stand back and looked at the manufacture process overall and assess how risks are interconnected and then trying tackle these risks head-on rather than simply attempting to score them as inconsequential for even the smallest incidences can become significant and lead to a loss of microbial control.
