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    Test method for the microbiological barrier properties of wrapping materials ; new approach

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    Authors
    Bruijn ACP de
    Wagner P
    Series/Report no.
    RIVM Rapport 319011007
    Type
    Report
    Language
    en
    
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    Title
    Test method for the microbiological barrier properties of wrapping materials ; new approach
    Translated Title
    [Testmethode voor de microbiologische barriere eigenschappen van verpakkingsmaterialen ; nieuwe aanpak.]
    Publiekssamenvatting
    The study shows that the new approach, as proposed by CEN TC102 wg4, for the development of a test method for the determination the microbial barrier properties of packaging materials for medical devices does not give the expected advances over the in 1990 presented LGM test method (RIVM-report 919000001, June 1990). The material qualification obtained by means of a materials test does not provide any relevant information about the expected performance of the material when formed into a final pack. The authors recognize the desirability for a materials test in the production of medical devices but the results show that the design of every type of packaging concept must be validated by means of a final pack test. This does however not exclude the use of a materials test for the purpose of in process control in the field of production. Once both the concept and the forming of the pack is validated a materials test will be very usefull to check whether the quality of the wrapping material is identical to the quality of the materials used in the validated packaging concept.
    Publisher
    Rijksinstituut voor Volksgezondheid en Milieu RIVM
    URI
    http://hdl.handle.net/10029/9990
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