Following on from Pharmig’s Irish conference (which focused on hot topics and current innovations for the microbiological assessment of pharmaceutical and hospital environments), Pharmig hosted a one -day meeting on pharmaceutical water systems. The quality of water used to formulate pharmaceuticals and to clean the equipment needs to be of the highest quality, both in terms of chemical purity and in relation to the permissible numbers and types of microorganisms and their cellular byproducts.
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The event was chaired by Tim Sandle and it took place at the Portmarnock Hotel & Golf Links, Dublin.
The first presentation was delivered, not by a microbiologist, but by a pharmaceutical engineer – Gordon Farquharson – Managing Director, Critical Systems Ltd. This presentation looked at the regulations surrounds pharmaceutical water systems (the GMPs – Good Manufacturing Practices) and how these differed and to a degree did not always provide the necessary clarity. The presentation moved on to look at some design issues required to keep water in a state of microbiological control, covering aspects like the need for water to move at a sufficient velocity through a pipe so that the shear forces were sufficient to prevent microbial surface attachment and the formation of a biofilm.
The second talk was from Andrew Gravett, who is an Associate Director at the Global Quality Audit Group for AstraZeneca. Gravett drew on his years of experience of auditing different pharmaceutical facilities to outline the requirements and expectations to audit against, including how to best structure a water system audit and to detail the common findings.
The third presentation was from Tim Sandle and it looked at bacterial endotoxin risks to water systems. Endotoxins are complexes released from the cell walls of Gram-negative bacteria (an organism morphological type associated with water). In sufficient concentration these toxins can, if they entered the human blood system, trigger a pyrogenic response (fever) or endotoxic shock (sepsis). Sandle described three case studies where poorly designed or maintained systems presented a contamination risk.
The fourth address to the meeting came from David Keen, who is a contamination control consultant at the disinfectant supplier Ecolab. This presentation looked at a grade of pharmaceutical water called purified water, focusing on its manufacture and associated risks. Keen spent time on the filtration process used to create appropriately graded water, demonstrating how water flows through numerous filtration systems made of sand, charcoal and gravel. This removes contaminants like dust, bacteria, chemicals and viruses.
Keen, in a separate presentation, looked at biofilms and the risk these complex structures pose to water systems. The requirements for biofilm formation reads like a simple recipe: a given concentration of planktonic bacteria, plus water, plus a surface, plus available nutrients (including a carbon source). The nutrient levels need only be relatively low. However, once present these communities can lead to continual recontamination through cells being siphoned off and biofilms, as Keen explained, are very difficult to remove requiring a combination of high heat and chemicals (and sometimes the removal of an entire branch of pipework).
This was followed by a presentation from Edel Fitzmaurice (Quality Director,Fitzmaurice Scientific Ltd.) which looked at ‘hot topics’ relating to water microbiology. This included discussion around a group of bacteria called Burkholderia cepacia complex, which is of concern to regulators especially to the U.S. Food and Drug Administration (FDA) due to the risk of causing pneumonia in immunocompromised individuals (especially when introduced into the air passages of a susceptible population, which can happen through medicines contaminated with pharmaceutical grade water of poor microbial quality).
The day ended with an interactive exercise where the delegates were presented with a series of engineering designs relating to a failing water system and attempted to solve a microbial contamination issue. The exercise bought together the main themes of the event, focusing on the importance of good design and maintaining control.
