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Pharmaceutical Manufacturing and Packing Sourcer
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A lot of time and money is spent removing contamination within cleanroom environments. But is enough being done to prevent contamination entering the cleanroom in the first place? And would a different procedure necessarily take more time?
"The transfer of materials into and out of the unit is one of the greatest potential sources of contamination", MCA Rules & Guidance for Pharmaceutical Manufacturers and Distributors 2002. The need for better transfer and disinfection procedures has been highlighted by studies looking into the bioburden on a range of items passed into pharmaceutical isolators (1). This work showed that around 60 per cent of items ready for transfer were contaminated with bacteria prior to disinfection. More significantly, 40 per cent of items were contaminated with bacterial spores that would not be removed by spraying with alcohol alone (see Table 1).
Further work was then carried out to assess the effectiveness of different liquid disinfection techniques (1) (see Table 2). Spraying and wiping was found to be the most effective method of transfer disinfection - especially against spores - because bacteria and spores can create a protective biofilm and therefore require the surface to be agitated by wiping to remove them.
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
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