Email
Password
Remember meForgot password?
    Log in with Twitter

article imageMicrobiologists 'colonize' Nottingham to discuss hot topics Special

By Tim Sandle     Nov 13, 2019 in Science
Nottingham - Each November pharmaceutical microbiologists converge for the annual Pharmig conference to discuss medicinal safety and the latest developments in all-things microbiology. On day one of year's event pharmaceutical regulators outlined their expectations.
The annual conference of the Pharmaceutical Microbiology Interest Group (Pharmig) is the most important global event of the year for pharmaceutical microbiologists, providing a platform for expert speakers to present on key topics and providing an open and interactive forum for discussion and debate for delegates.
Pharmig committee members at the Pharmig stand  welcoming conference delegates.
Pharmig committee members at the Pharmig stand, welcoming conference delegates.
The 2019 conference, the 27th, took place in Nottingham, U.K. The opening presentation was delivered by Phil Rose of the U.K. pharmaceutical regulatory agency (the Medicines and Healthcare products Regulatory Agency, MHRA). Rose, a Good Distribution and Manufacturing Practice inspector, provided a survey of hot topics from visits made by inspectors to pharmaceutical facilities. The most important message conveyed was in relation to risk assessments, where Rose cautioned that risk assessments need to be science based and they should not be constructed in such a way that they jump to conclusions. He added that low risk should mean low risk, and that risk prioritisation is a necessary step so that the most important risks can be tackled first.
READ MORE: Microbiologists become more 'cultured' after annual conference
MHRA GDMP inspector Phil Rose addressing the Pharmig conference on contamination control.
MHRA GDMP inspector Phil Rose addressing the Pharmig conference on contamination control.
Rose also pointed out some pitfalls with the contamination control monitoring plans in use in many pharmaceutical facilities and called for a logical and process-based approach; this was based upon understanding what is happening during manufacturing an orientating environmental monitoring samples appropriately so that they are signalling information that means something in relation to the risk of pharmaceutical product contamination.
Delegates meandering among the exhibition stands at the Pharmig 2019 conference.
Delegates meandering among the exhibition stands at the Pharmig 2019 conference.
The second presentation of the day was delivered by Kim Moorwood of MGS Laboratories and this looked at how chemical disinfectants are evaluated. The presentation covered differences between efficacy methods and forthcoming changes. Qualifying disinfectants in important, as this provides valuable data in terms of how effective a given disinfectant is in terms of reducing a microbial population. Moorwood made an important point about ensuing that surface to which a disinfectant is applied remain wet for the required contact times - the time that I necessary to ensure that the disinfectant traverses the microbial cell wall in order to initiate cellular destruction.
Alternative shot of the Pharmig conference delegate all  where a range of microbiological applicatio...
Alternative shot of the Pharmig conference delegate all, where a range of microbiological applications are on display.
The third talk of the day was about barrier technology, which creates a clean space in order to ensure that when medicinal products are dispensed the possibility of microorganisms getting in is significantly reduced. The talk was delivered by Mark Hodgson of GlaxoSmithKiline (GSK). In his talk, Hodgson, a process manager, placed an important emphasis upon controlling the variables of temperature and humidity. He also addressed the challenges around glove leakage.
Conference room at the Pharmig event  where over 100 delegates attended to discuss important microbi...
Conference room at the Pharmig event, where over 100 delegates attended to discuss important microbiology topics.
Donald Singer, who serves on the microbiology committee of the United States Pharmacopeia, provided an overview of developments that the committee has worked on (such as a new chapter for the objectionable microorganism and potential contaminant of inhalation products - Burkholderia cepacia) and forthcoming changes, including new sterilization technologies.
Robert Smith introduced the microbiological concerns impacting on the development of advanced therapy medicinal products, looking at practical challenges and considering the appropriate rapid microbiological methods that can help to establish sterility assurance during manufacturing. Smith sees that the final product quality is linked to quality of the starting material, in terms of ensuring microbial control.
A cleanroom suit  designed for an aseptic processing area cleanroom on show at the Pharmig event.
A cleanroom suit, designed for an aseptic processing area cleanroom on show at the Pharmig event.
The sixth presentation came from Professor Willy Verstraete (Ghent University), which considered how the aerobic fermentation of microbial biomass can offer a low carbon means to provide animal feed, as well as a potential food source that is environmentally sustainable. In June 2018 Professor Verstraete received from the Flemish Government the Great Award Distinction for his contributions to science and scientific governance.
Technology for the microbiological monitoring of cleanrooms  including a particle counter.
Technology for the microbiological monitoring of cleanrooms, including a particle counter.
The seventh and final presentation of the day was delivered by global subject matter expert Jeanne Moldenhauer, and this provided a detailed overview of the requirements for contamination control strategy, based on quality risk management. A holistic approach to contamination control was recommended, extending to in-coming raw material supply and out through the distribution chain in terms of container-closure security.
Exhibitors at the 2019 Pharmig conference.
Exhibitors at the 2019 Pharmig conference.
Throughout day on several interactive open discussion sessions took place, supported by a range of suppliers offering the latest contamination control technologies.
Read about day 2 of the conference, here.
More about pharmig, regulatory, Medicine, Microbiology, Pharmaceuticals
More news from
Latest News
Top News