Organized by Pharmig (Pharmaceutical Microbiology Interest Group) the conference took place at the Portmarnock Hotel & Golf Links, Co. Dublin, a picturesque setting close to the Irish sea and the Portmarnock Beach with its wide, expansive sands.
The aim of the conference was to help those tasked with ensuring that both sterile and non-sterile medicines are not placed at risk from microbial contamination. With sterile products (such as biologics injected into the bloodstream) the aim is to have no microorganisms present; with non-sterile products (such as tablets and ointments), the aim is to produce products that are free of pathogenic organisms that are a concern to the way the product is administered.
The conference began with a presentation by Tim Sandle, comparing and contrasting U.S. and European standards and regulations for manufacturing medicines in relation to microbial control. The presentation focused on the strengths of different barrier technologies where, for products produced aseptically, minimizing the impact of people was key (given that people are the biggest source of contamination through the shedding of microbial carrying skin particles). The presentation also covered different ways for the collection and presentation of data.
The second presentation was delivered by Edel Fitzmaurice and it looked at designing an environmental monitoring programme. An environmental monitoring programme indicates whether a pharmaceutical facility is in state of environmental control. Control is achieved through appropriate clean air ventilation; good gowning; personnel following best aseptic techniques; and via a robust cleaning and disinfection program.
The third presentation was delivered by Richard Fitzpatrick and it considered how to approach the identification of microorganisms. There are several reasons why developing this strategy is important. Two called out were, with sterile products, the need to find an origin of the source of contamination; and with non-steriles, in assessing the risk of any objectionable organisms getting into the medicinal product.
The presentations were interspersed with exhibition standard unveiling the latest in microbiological monitoring technology. In recent years there has been a driver for rapid and alternative microbiological methods and several were showcased.
The presentations and exhibition space was located close to the older part of the hotel. The hotel is built on part of the original Jameson family estate. John Jameson and his son (also John Jameson) took ownership of the Bow Street Distillery in Dublin and created the popular blended Irish whiskey ‘Jamesons’. Part of the original building is shown in the photograph below.
The fourth presentation was delivered by Kate Coleman and it focused on investigating high microbial counts and out-of-trend situations. The presentation included several useful tools for conducting such analysis, such as ‘is / is not’ tables and fishbone diagrams.
This was followed by a second presentation by Tim Sandle, which looked at microbial incubation strategies. Classic microbiology is faced by the problem that over 90 percent of the microorganisms in the environment are what are termed ‘active but non-culturable’, meaning that they could cause patient harm if the ended up in the body but microbiologists have difficulty assessing them. This places considerable emphasis upon environmental control. For those organisms that can be cultured, the microbiologist has the dilemma of which agars to use and the appropriate temperature and time to incubate for. The presentation included a case study showing how this might be assessed.
The sixth presentation was from Sinead Cowman and it was on data handling and data integrity. This was become a regulatory ‘hot topic’ in the past couple of years and it centers on the validity and care of collected data. This extends to both computerized systems and manual means for recording results. A useful acronym when considering data integrity is ALCOA; data must be attributable, legible (permanent), contemporaneous, original and accurate.
The final presentation was a second from Richard Fitzpatrick and it looked at bacterial endotoxin (a pyrogenic compounds released by Gram-negative bacteria). The presentation took the form of a case study, safeguarding medical devices before they are released into the market.
Drawing the presentations together, the overriding theme of the conference was on developing a sound contamination control strategy designed to provide meaningful information so that microbial risks can be monitored and, where necessary, quickly and effectively addressed.
