Sterilisation Wrap or Rigid Sterilisation Containers?


New study1 shows that after terminal sterilisation 100% of the packages wrapped in HALYARD* sterilisation wrap are free of bacterial contamination.

A recent study showed – after terminal sterilisation – that 100%1 of the sterilised packaged wrapped in HALYARD* sterilisation wrap remained sterile whereas 87%1 of rigid sterilisation containers did not maintain sterility through transport and handling.

Surprisingly also 72%1 of new sterilisation containers showed contamination.

You may want to learn more about the bacterial barrier performance of HALYARD* Sterilisation wrap and/or the performance of rigid containers: this web page provides you with summaries of clinical, peer reviewed publications.

HC407_Icon  Single or multiple wrapping of medical devices: procedure assessment through research.
A.C.P. de Bruijn and J. Kastelein; Zentralsterilisation, 7, Jahrgang 1999.
In this study, various types of packaging material, including containers are challenged with latex particles. This study is performed by TNO who developed the so called final pack test. The study confirms the efficiency of the Halyard One-Step packaging technique.
HC477_Icon Influence of prion sterilisation cycle on the bacterial barrier performance of sterilisation wrap according to the final pack test
J. Kastelein et al; Zentralsterilisation, 2013; 21 (4): 277–284.
Using the final pack test after an 18 minutes sterilisation cycle the study demonstrates that HALYARD* sterilisation wrap is not affected by the prion cycle. The study also includes results 3 months post sterilisation. This study was funded by Kimberly-Clark, predecessor corporation to Halyard Health, Inc
PPT_Icon Measurement of the microbial barrier effectiveness of sterilisation containers in terms of the log reduction value for prevention of nosocomial infections.
Hartmut Dunkelberg, MD, Friederike Fleitmann-Glende, MS; Am J Infect Control 2006;34:285-9. The author of this study challenges a number of sterilised containers using S cerevisiae. To download a free copy, please click here
HC486_Icon Sterility maintenance study: dynamic evaluation of sterilised rigid containers and wrapped instruments to prevent bacterial ingress.
Harry L. Shaffer, MS et al. Am J, Infect Control. 2015 Dec;43(12)1336–1341.
This is a head to head comparison of rigid containers and package wrapped in HALYARD sterilisation wrap using a bio aerosol.


After reading the summary, would you like to review the full clinical paper? Do not hesitate to let us know and we will provide you a digital copy of the study. 


1 Harry L. Shaffer MS†, Delbert A. Harnish MS†, Michael McDonald MS, Reid A. Vernon BS, Brian K. Heimbuch MS†. Sterility maintenance study: Dynamic evaluation of sterilised rigid containers and wrapped instrument trays to prevent bacterial ingress. Am J Infect Control. 2015 Dec;43(12)1336–1341. 

Research for the sterility maintenance study was funded by Halyard Health, Inc., a manufacturer of sterilisation wrap.

161 wrapped trays were tested.

111 rigid containers were tested. Out of 111 rigid containers tested, 14 (12.6%) had no bacterial ingress, 25 (22.5%) had ingress of 1-9 CFU, 52 (46.8%) had ingress of 10-99 CFU, and 20 (18.0%) had ingress >100 CFU.

72% of unused containers showed bacterial ingress.

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