Definition of a correlation between microbiological and physical particulate barrier performances for porous medical packaging materials.

PDA J Pharm Sci Technol

Air Dispersions Ltd., Manchester Science Park, Manchester M15 6SE, U.K.

Published: March 2002

An experimental set up, assembled principally from components of commercially available filter test equipment, has allowed assessment of physical particulate barrier performance of porous materials. Employing twelve specially made papers with graded and widely different barrier properties, a physical particulate/microbiological correlation has been derived covering the 50,000 fold range of microbiological barrier performances seen in commercial porous medical packaging materials. The derived correlation has been shown to be independent of sheet structure and is applicable to the diverse structures that comprise commercial materials. A simple measurement of particle penetration is proposed as a means of assessing microbial barrier properties of such materials.

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