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Process Worldwide-PharmaTEC 01-2003
Hot stuff
Effective alternatives to chemical disinfection

Even if a lot of people don’t like hearing it, pharmaceutical water equipment operated at room temperature is generally affected by bacterial attack. Good design can reduce long-term bacterial contamination in the various process steps, but to prevent bacterial contamination in the long-term and to provide process evaluation capability, you need regular maintenance and good monitoring.
Two types of microorganisms cause problems in pharmaceutical water systems: planktonic cells are transported in the water flow and sessile biofilms form on the inner surfaces of pipes and valves, on container walls and on resin or membrane surfaces. When various generally known pharmaceutical aspects are given proper consideration in the design phase, the formation of biofilms can be reduced but not altogether prevented. Options include maintaining high flow rates, using smooth surfaces, designing in valves and pipes that are suitable for pharmaceutical applications, and minimizing dead space and areas with low flow rates. A crucial step in preventing colony formation is sanitizing or disinfecting a system in conjunction with effective monitoring to ensure that action is taken in a timely manner. Periodic, occasional or unexplained high colony counts could be caused by shedding of biofilm, for example.
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