http://www.digitaljournal.com/tech-and-science/science/microbiologists-assess-ways-to-lower-medicine-contamination-risks/article/493488

Microbiologists assess ways to lower medicine contamination risks Special

Posted May 25, 2017 by Tim Sandle
Microbiologists from a range of pharmaceutical and healthcare companies convened in Dublin to attend a conference discussing how to effectively monitor the built environment for risks in relation to drug product manufacturing.
Microbiologists discussing the latest technologies for contamination control at the exhibition part ...
Microbiologists discussing the latest technologies for contamination control at the exhibition part of Pharmig's Irish conference.
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 Portmarnock Hotel & Golf Links  Co. Dublin  a hotel by the sea.
The Portmarnock Hotel & Golf Links, Co. Dublin, a hotel by the sea.
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.
Conference delegates socializing the evening before the study day.
Conference delegates socializing the evening before the study day.
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.
Speaker Richard Fitzpatrick addresses the delegates at the Pharmig event.
Speaker Richard Fitzpatrick addresses the delegates at the Pharmig event.
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.
Conference delegates discussing the latest microbiological technology at the Pharmig event.
Conference delegates discussing the latest microbiological technology at the Pharmig event.
Microbial technology for assessing the sterility of medicinal products on show.
Microbial technology for assessing the sterility of medicinal products on show.
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.
A peak into the old part of the Portmarnock Hotel & Golf Links  Co. Dublin  where parts of the origi...
A peak into the old part of the Portmarnock Hotel & Golf Links, Co. Dublin, where parts of the original Jameson estate are to be found.
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.
Sinead Cowman delivering her lecture at the Pharmig conference on data integrity.
Sinead Cowman delivering her lecture at the Pharmig conference on data integrity.
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.
A closing shot of the Portmarnock Hotel & Golf Links  Co. Dublin  and one of its interesting gardens...
A closing shot of the Portmarnock Hotel & Golf Links, Co. Dublin, and one of its interesting gardens.