Examining the Effect of Secondary Packaging on Microbial Penetration into Sterile Medical Device Trays

Authors

Ondrea Kassarjian Kassarjian, Michigan State UniversityFollow
Nora Bello, Kansas State UniversityFollow
Laura Bix, Michigan State UniversityFollow
Gary Burgess, Michigan State UniversityFollow
John Linz, Michigan State UniversityFollow

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This work is licensed under a Creative Commons Attribution 3.0 License.

Abstract

device trays was examined. Sterile device trays were aseptically filled with growth medium, exposed to microbial challenge, incubated, and inspected for growth. During microbial challenge, all package systems were subjected to a pressure differential that simulated those experienced during distribution. Penetration rates were significantly decreased (P = 0.01) when unlidded trays were packaged in pouches (0/39), compared to those in cartons (37/39). Similarly, the number of colony forming units (CFU) present was greater for unlidded trays packaged in cartons, compared to those in pouches (P = 0.03). To further explore the efficacy of cartons as a barrier to microbial ingress, lidded trays with a single 100 μm breach were packaged in cartons and subjected to the same methodologies; approximately 15% exhibited growth. When compared to unlidded trays, penetration rates (P

Erratum

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Recommended Citation

Kassarjian, Ondrea Kassarjian; Bello, Nora; Bix, Laura; Burgess, Gary; and Linz, John (2014) "Examining the Effect of Secondary Packaging on Microbial Penetration into Sterile Medical Device Trays," Journal of Applied Packaging Research: Vol. 6: No. 1, Article 2.
DOI: 10.14448/japr.01.0001
Available at: https://repository.rit.edu/japr/vol6/iss1/2