Hostname: page-component-84b7d79bbc-x5cpj Total loading time: 0 Render date: 2024-07-30T23:59:15.788Z Has data issue: false hasContentIssue false
  • English
  • Français

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
Get access Rights & Permissions [Opens in a new window]

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

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1.American Society for Testing and Materials. F2097-01: Standard Guide for Design and Evaluation of Primary Packaging for Medical Products. West Conshohocken, PA: American Society for Testing and Materials International; 2002.Google Scholar
2.Alfa, MJ, Oison, N, DeGagne, P, Jackson, M. Evaluation of rapid readout biological indicators for 132°C gravity and 132°C vacuum-assisted steam sterilization cycles a new automated fluorescent reader. Infect Control Hosp Epidemiol 2002;23:388–392.Google Scholar
3.European Committee for Standardization. EN 868-1: Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized— Part 1. General Requirements and Test Methods. Brussels: European Committee for Standardization; 1997.Google Scholar
4.European Committee for Standardization. EN 556-1: Requirements for Medical Devices to Be Designated “STERILE”—Part 1. Requirements for Terminally Sterilized Medical Devices. Brussels: European Committee for Standardization; 2001.Google Scholar
5.Dunkelberg, H, Wedekind, S. A new method for testing the effectiveness of the microbial barrier properties of packaging materials for sterile products. Biomed Tech (Berl) 2002;47:278–284.Google Scholar
6.Normenausschuss Medizin (NA Med): DIN 58953 Teil 10. Berlin: Beuth Verlag; 1987.Google Scholar
7.Kelsey, JC. The myth of surgical sterility. Lancet 1972;2:1301–1303.Google Scholar
8.European Committee for Standardization. EN 554: Sterilization of Medical Devices—Validation and Routine Control of Sterilization by Moist Heat. Brussels: European Committee for Standardization; 1994.Google Scholar
9.Butt, WE, Bradley, DV, Mayhew, RB, Schwartz, RS. Evaluation of the shelf life of sterile instrument packs. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1991;72:650–654.Google Scholar
10.Standard, PG, Mackel, DC, Mallison, GF. Microbial penetration of muslin- and paper-wrapped sterile packs stored on open shelves and in closed cabinets. Appl Microbial 1971;22:432–437.Google Scholar
11.Standard, PG, Mallison, GF, Mackel, DC. Microbial penetration through three types of double wrappers for sterile packs. Appl Microbiol 1973;26:59–62.CrossRefGoogle ScholarPubMed
12.De Bruijn, ACP, Kastelein, J. Single or multiple wrapping of medical devices: procedure assessment through research. Zentral Sterilisation 1999;7:292–303.Google Scholar
13.Junghannβ, U, Winterfeld, S, Gabele, L, Kulow, U. Hygienic-microbiological and technical testing of sterilizer container Systems. Zentral Sterilisation 1999;7:154–162.Google Scholar