Coronavirus (COVID-19) FAQs for Tyvek® Medical & Pharmaceutical Packaging

Article
Coronavirus (COVID-19) FAQs for Tyvek Medical & Pharmaceutical Packaging
 
 
 

Updated: April 8, 2020

As we continue to monitor the spread of COVID-19, we recognize that our value chain partners have questions pertaining to packaging made from Tyvek® Medical & Pharmaceutical Packaging (MPP) styles. We are working to ensure that healthcare professionals and customers have up-to-date information.

See also: Latest news and DuPont™ response to Coronavirus (COVID-19) prevention and control

Can Tyvek® packaging be disinfected on the outside with isopropanol (IPA) or ethanol?

NO. Based on the information currently available, this is not recommended. Both IPA and ethanol have low surface tension and will permeate through the Tyvek® sheet which could potentially allow for microorganisms to penetrate the packaging (e.g. bacterial endospores, which are not inactivated by alcohol[1]). 

If emergency disinfection measures are necessary before opening medical packages to control the risk of SARS-CoV-2 contamination, wiping with aqueous disinfectants such as 0.5% hydrogen peroxide or 0.1% sodium hypochlorite is preferred. Due to the hydrophobic nature of Tyvek®, water-based disinfectants will not penetrate through the Tyvek® sheet as readily as alcohol. Application with spray is not recommended.

It is recommended to use double or triple entry packaging to help reduce the risk of contamination of outside package surfaces to control the risk of further potential contamination during aseptic opening.

See also references for further information [2-4].

How long can the SARS-CoV-2 virus survive on a Tyvek® surface?

DuPont has not conducted studies on survival of the SARS-CoV-2 virus on Tyvek®.

According to a recent study published in March 2020 by the New England Journal of Medicine[5], SARS-CoV-2 can survive on various surfaces for a period of a few hours to multiple days depending on the material. Based on this study, viable virus was detected for up to 3 days on a plastic surface. Tyvek® is a porous material made of high-density polyethylene (HDPE). Viruses have been shown to transfer less efficiently from porous surfaces compared to non-porous surfaces[6].

See also references for further information [3-5, 7-9].

Can Tyvek® be re-sterilized?

Re-sterilization of products packaged in Tyvek® is routinely done if validated by the medical device manufacturer. Packaging and device functionality can be adversely affected by repeat exposures if performed outside the medical device manufacturer’s stated claims or number of uses. Please refer to the Tyvek® Technical Reference Guide (page 33) for sterilization compatibility, and the medical device instructions for Use (IFU).

Can Tyvek® be subjected to UV- Sterilization/disinfection?

DuPont does not have efficacy or performance data on Ultraviolet germicidal irradiation (UVGI) exposure to Tyvek®. 

UVGI using short-wavelength ultraviolet (UV-C) light has been used for many years[12]. Studies show that UV-C is able to inactivate Coronaviruses[11].  Tyvek® is made of high-density polyethylene (HDPE). Care should be taken as HDPE is susceptible over time to UV degradation and compatibility should be assessed following requirements of ISO 11607-1 to understand long-term stability.  

Can Tyvek® Medical & Pharmaceutical Packaging or other styles be used for face masks?

DuPont has a wide range of commercial Tyvek® styles to meet different needs; however, none of our Tyvek® styles are fit for use in a respiratory protection application.

DuPont does have another nonwoven material (DuPont™ Xavan®) that is used as a stiffener and support layer for the filter media for respiratory face masks. If you are interested in more information about this material, contact: Katja.gross@dupont.com

Are Tyvek® styles for Healthcare packaging applications offering adequate protection against SARS-CoV-2 ?

DuPont™ Tyvek® is made up of a dense web of randomly oriented, continuous filaments of high-density polyethylene (HDPE) that provides an excellent microbial barrier performance. Tyvek® is also hydrophobic and holds out water until a fairly high pressure (see misc properties).

DuPont™ Tyvek® styles for medical and pharmaceutical packaging applications have not been specifically tested for the penetration of viruses, blood and body fluids using protective clothing test methods like ASTM F1670[13] and ASTM F1671[14] nor for ISO 16603[15] and ISO 16604[16] because these liquid based tests are not applicable to medical packaging. Tyvek® microbial barrier properties are tested using aerosolized bacterial spores according to ASTM F1608[17] or with particles according ASTM F2638[18]. The use of ASTM F2638, a physical test method, is based on research by Alan Tallentire and Colin Sinclair. The research concluded that the filtration of microorganisms follows the same mechanisms as particle filtration[19]. Research on face mask test methods has shown that the viral filtration efficiencies (VFE method) and bacterial filtration efficiencies (BFE method) yield similar results[20]

 
 
 

References

1. Centers for Desease Control and Prevention (CDC). Chemical Disinfectants - Guideline for Disinfection and Sterilization in Healthcare Facilities (2008). 2008  3 Apr 2020]; Available from: https://www.cdc.gov/infectioncontrol/guidelines/disinfection/disinfection-methods/chemical.html.

2. Centers for Desease Control and Prevention (CDC). List N: Disinfectants for Use Against SARS-CoV-2. 2020; Available from: https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2.

3. Kampf, G., et al., Persistence of coronaviruses on inanimate surfaces and their inactivation with biocidal agents. Journal of Hospital Infection, 2020. 104(3): p. 246-251.

4. Kampf, G., Potential role of inanimate surfaces for the spread of coronaviruses and their inactivation with disinfectant agents. Infection Prevention in Practice, 2020. 2(2): p. 100044.

5. van Doremalen, N., et al., Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. New England Journal of Medicine, 2020.

6. Lopez, G.U., et al., Transfer efficiency of bacteria and viruses from porous and nonporous fomites to fingers under different relative humidity conditions. Applied and environmental microbiology, 2013. 79(18): p. 5728-5734.

7. Bean, B., et al., Survival of Influenza Viruses on Environmental Surfaces. The Journal of Infectious Diseases, 1982. 146(1): p. 47-51.

8. Firquet, S., et al., Survival of Enveloped and Non-Enveloped Viruses on Inanimate Surfaces. Microbes and environments, 2015. 30(2): p. 140-144.

9. Centers for Desease Control and Prevention (CDC). How Coronavirus Spreads. 2020  2 April 2020]; Available from: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html.

10. Rabenau, H., et al., Stability and inactivation of SARS coronavirus. Medical microbiology and immunology, 2005. 194: p. 1-6.

11. Darnell, M., et al., Inactivation of the coronavirus that induces severe acute respiratory syndrome, SARS-CoV. Journal of virological methods, 2004. 121: p. 85-91.

12. Centers for Desease Control and Prevention (CDC). Miscellaneous Inactivating Agents - Guideline for Disinfection and Sterilization in Healthcare Facilities (2008). 2008  2 April 2020]; Available from: https://www.cdc.gov/infectioncontrol/guidelines/disinfection/disinfection-methods/miscellaneous.html.

13. ASTM International, ASTM F1670 / F1670M - 17a - Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood (https://www.astm.org/Standards/F1670.htm). 2017.

14. ASTM International, ASTM F1671 / F1671M - 13 -Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System (https://www.astm.org/Standards/F1671.htm). 2013.

15. International Organization for Standardization, ISO 16603:2004 - Clothing for protection against contact with blood and body fluids — Determination of the resistance of protective clothing materials to penetration by blood and body fluids — Test method using synthetic blood. 2004.

16. International Organization for Standardization, ISO 16604:2004 - Clothing for protection against contact with blood and body fluids — Determination of resistance of protective clothing materials to penetration by blood-borne pathogens — Test method using Phi-X 174 bacteriophage. 2004.

17. ASTM International, ASTM F1608-16: Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method). 2016.

18. ASTM International, ASTM F2638 - 18: Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier 2018: West Conshohocken - PA 19428-2959, United States.

19. Sinclair, C.S. and A. Tallentire, Definition of a Correlation Between Microbiological and Physical Particulate Barrier Performances for Porous Medical Packaging Materials. PDA Journal of Pharmaceutical Science and Technology, 2002. 56(1): p. 11-19.

20. Rengasamy, S., et al., A comparison of facemask and respirator filtration test methods. Journal of Occupational and Environmental Hygiene, 2017. 14(2): p. 92-103.

 
 
 

This information is based on technical data DuPont believes to be reliable. It is subject to revision as additional knowledge and experience are gained. It is not intended as a substitute for any testing you may conduct to determine for yourself the suitability of our products for your particular purpose. Since conditions of use are outside the Company’s control, DuPont makes no warranties, express or implied, and assumes no liability in connection with any use of this information. DuPont™, the DuPont Oval Logo, and all trademarks and service marks denoted with TM, SM or ® are owned by affiliates of DuPont de Nemours, Inc. unless otherwise noted. © 2020 DuPont. (04/20)