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Infection Control & Hospital Epidemiology Infection Control & Hospital Epidemiology

Article contents

Preliminary Results for a New Final Package Test to Assess the Quality of Sterile Package Systems

Published online by Cambridge University Press:  02 January 2015

Hartmut Dunkelberg  and
Silke Wedekind
Hartmut Dunkelberg*
Affiliation:
Medical Institute of General Hygiene and Environmental Health, University of Goettingen, Goettingen, Germany
Silke Wedekind
Affiliation:
Medical Institute of General Hygiene and Environmental Health, University of Goettingen, Goettingen, Germany
*
Medical Institute of General Hygiene and Environmental Health, University of Goettingen, Windausweg 2, D-37073 Goettingen, Germany
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Abstract

Objectives:

To develop a microbial test method to ascertain the passage of airborne bacteria through the medical device packaging System after sterilization, and to apply this test method to flexible packages under mechanical pressure changes.

Methods:

Petri dishes filled with nutrient agar were integrated into the packaging unit prior to sterilization. We examined paper packaging consisting of 1 (single-paper packaging [P]), 2 (double-paper packaging [PP] and textile and paper double packaging [TP]), and 3 (double packaging with transport packaging [TPP]) layers. After sterilization, the test packages were pressed five times per minute for 1 or 3 hours by a mechanical device weighing 1 kg. This exposure took place in rooms with an average airborne bacterial count of 35 (room 1) or 440 (room 2) CFU/m3. The packaging was opened following culture at 37° C for 48 hours to determine the number of colonies formed.

Results:

The proportion of contaminated packages rose with the duration of mechanical stress and increased airborne bacteria concentration. Thus, mechanical pressure change for 3 hours resulted in the contamination of 60% (P), 15% (PP), 0% (TP), and 0% (TPP) of the packages in room 1, whereas 100% (P), 65% (PP), 73% (TP), and 0% (TPP) of the packages in room 2 were contaminated.

Conclusions:

This test method allows sterile packaging Systems to be tested for contamination under practical conditions without extensive laboratory preparation. Contamination as a resuit of laboratory errors can be ruled out almost certainly.

Type
Original Articles
Information
Infection Control & Hospital Epidemiology , Volume 25 , Issue 1 , January 2004 , pp. 26 - 29
Copyright
Copyright © The Society for Healthcare Epidemiology of America 2004

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References

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