Workshop at the 22nd A3P Congress: Control of microbiological contamination on a water loop

Samah Ringa Moderator of the workshop

Workshop N°5 organised at the 22nd A3P Congress, October 20th, 21st and 22nd, 2009

Controlling microbial contamination on a water loop requires a comprehensive approach that includes implementing solutions from design to daily operation of the purified water circuit.

In the pharmaceutical industry, water can be used as an excipient, be used as a solvent in the reconstitution of a finished product, participate in synthesis steps or even be used as an agent for cleaning.
The Pharmacopoeias define the qualitative aspects of water and their method of production for each stage of their process. 

To fullfill the requirements of the industry, process requires use of a purified water or highly purified water, according to the USP standards of the European Pharmacopoeia, the exploitation of the water loop should be the subject of a comprehensive approach. The best approach to fight against the risks of microbiological contamination on a water loop is to observe, from the design of the loop to its daily operation, criteria and extremely strict procedures which will guarantee a dynamic control.   During this workshop, speakers, Samah RINGA (Pharma Market Responsible / PERMO) & Eric Petat (Pharmacist Biologist / ACM Pharma) will seek to demonstrate that there exist effective means and processes to put in place to control the microbiological contamination on a water loop.

Beyond the theoretical and operational standards applicable to different categories of pharmaceutical water, real situations of contamination will be subject to the investigative perspicacity of participants.   They will work in group on concrete cases of contamination which will be subjected to them to identify the possible causes and to propose their own corrective and preventive solutions.   In a second time, after examination of the various proposals of solutions given, in the synthesis will be written, through a decisional logigramme, each action necessary to set up to manage and prevent the risk of contamination on an installation of purified water; this will be done step by step from the design to the daily exploitation, including distribution and control operations.   Program