Prevention of coronavirus contamination from the environment using an air-cleaning closed system drug-transfer device

Main Article Content

Maya Amichay
Ortal Shimon
Eitan Raveh https://orcid.org/0000-0001-7102-1261

Keywords

COVID-19, Drug preparation, Viral contamination

Abstract

Background: Closed system drug-transfer devices (CSTD) allow the reconstitution of hazardous drugs into infusion bags, while preserving the sterility of the product and preventing the escape of liquids and aerosols into the environment. Air-cleaning technology CSTD is based on an activated carbon filter and a membrane which enable maintaining the drug sterile by filtration of air entering the vial during pressure equalization. Objective: The study aimed to investigate if an air-cleaning CSTD can prevent liquid viral contamination by human coronavirus OC43 (HCoV-OC43). Methods: ChemfortTM CSTD with (intact) or without (control) a Toxi-Guard system was used to transfer liquids between an IV bag and an empty vial (a total of 5 liquid transfers) inside a sealed glove box contaminated by HCoV-OC43 aerosols. In addition, the vial adaptor was challenged by direct spray of HCoV-OC43 solution on the septum and filter areas. HCoV-OC43 RNA was extracted from samples of the transferred liquid and compared between the devices with or without a Toxi-Guard system. Results: Use of a CSTD with the Toxi-Guard system resulted in non-detectable cycle threshold (CT) values, indicative of no detectable HCoV-OC43RNA in the transferred liquid, even when the septa and filter areas were directly sprayed with HCoV-OC43 stock solution. In contrast, use of the CSTD with no Toxi-Guard system resulted in a detectable CT value of the transferred liquid. Conclusions: Using Chemfort CSTD with integral Toxi-Guard technology can prevent the introduction of microbial and airborne contaminants into the fluid path, thus potentially protecting patients from infection.

Downloads

Download data is not yet available.
Abstract 427 | pdf Downloads 266

References

1. Hernandez-Ramos I, Gaitan-Meza J, Garcia-Gaitan E, et al. Extrinsic contamination of intravenous infusates administered to hospitalized children in Mexico. Pediatr Infect Dis J. 2000;19:8-90. https://doi.org/10.1097/00006454-200009000-00017
2. Macias AE, de Leon SP, Huertas M, et al. Endemic infusate contamination and related bacteremia. Am J Infect Control. 2008;36:48-53. https://doi.org/10.1016/j.ajic.2007.02.003
3. Macias AE, Huertas M, de Leon SP, et al. Contamination of intravenous fluids: a continuing cause of hospital bacteremia. Am J Infect Control. 2010;38:217-21. https://doi.org/10.1016/j.ajic.2009.08.015
4. Muller AE, Huisman I, Roos PJ, et al. Outbreak of severe sepsis due to contaminated propofol: lessons to learn. J Hosp Infect. 2010;76:225-30. https://doi.org/10.1016/j.jhin.2010.06.003
5. Vonberg RP, Gastmeier P. Hospital-acquired infections related to contaminated substances. J Hosp Infect. 2007;65:15-23. https://doi.org/10.1016/j.jhin.2006.09.018
6. Barone PW, Wiebe ME, Leung JC, et al. Viral contamination in biologic manufacture and implications for emerging therapies. Nature Biotechnology. 2010;38:563-72. https://doi.org/10.1038/s41587-020-0507-2
7. Merten OW. Virus contaminations of cell cultures - A biotechnological view. Cytotechnology. 2002; 39:91-116. https://doi.org/10.1023/A:1022969101804
8. Besheer A, Burton L, Galas RJ, et al. An Industry Perspective on Compatibility Assessment of Closed System Drug-Transfer Devices for Biologics. J Pharm Sci. 2021;110:610-4. https://doi.org/10.1016/j.xphs.2020.10.047
9. NIOSH. Preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings. 2004
10. Levin G, Sessink PJ. . Validation of chemotherapy drug vapor containment of an air cleaning closed-system drug transfer device. J Oncol Pharm Pract. 10781552211030682. https://doi.org/10.1177/10781552211030682
11. Sessink PJM, Nyulasi T, Haraldsson ELM, et al. Reduction of Contamination with Antibiotics on Surfaces and in Environmental Air in Three European Hospitals Following Implementation of a Closed-System Drug Transfer Device. Ann Work Expo Health. 2019;63:459-67. https://doi.org/10.1093/annweh/wxz010
12. Sellaoui L, Badawi M, Monari A, et al. Make it clean, make it safe: A review on virus elimination via adsorption. Chemical engineering journal (Lausanne, Switzerland : 1996). 2021;412:128682. https://doi.org/10.1016/j.cej.2021.128682
13. Health Protection Agency, UK, Antiviral Testing Of FlexzorbTM, data on file, 2009
14. Bartel SB, Tyler TG, Power LA. Multicenter evaluation of a new closed system drug-transfer device in reducing surface contamination by antineoplastic hazardous drugs. Am J Health Syst Pharm. 2018;75:199-211. https://doi.org/10.2146/ajhp160948
15. Harrison BR, Peters BG, Bing MR. Comparison of surface contamination with cyclophosphamide and fluorouracil using a closed-system drug transfer device versus standard preparation techniques. Am J Health Syst Pharm. 2006;63:1736-44. https://doi.org/10.2146/ajhp050258
16. Sessink PJ, Connor TH, Jorgenson JA, et al. Reduction in surface contamination with antineoplastic drugs in 22 hospital pharmacies in the US following implementation of a closed-system drug transfer device. Journal of Oncology Pharmacy Practice. 2011;17:39-48. https://doi.org/10.1177/1078155210361431
17. Valero S, Lopez-Briz E, Vila N, et al. Pre and post intervention study of antiblastic drugs contamination surface levels at a Pharmacy Department Compounding Area using a closed system drug transfer device and a decontamination process. Regul Toxicol Pharmacol. 2018;95. https://doi.org/10.1016/j.yrtph.2018.03.001
18. Mills A, Yousef M. Sterility testing using a closed system transfer device in oncology medication compounding: a novel method for testing partially used vials. Drugs & Therapy Perspectives. 2021;37: 206-11. https://doi.org/10.1007/s40267-021-00823-4
19. Soubieux A, Tanguay C, Bussieres JF. Review of studies examining microbial contamination of vials used for preparations done with closed-system drug transfer devices. Eur J Hosp Pharm. 2021;28:65-70. https://doi.org/10.1136/ejhpharm-2019-001913
20. Azhar EI, Hashem AM, El-Kafrawy SA, et al. Detection of the Middle East respiratory syndrome coronavirus genome in an air sample originating from a camel barn owned by an infected patient. mBio. 2014;5:e01450-14. https://doi.org/10.1128/mBio.01450-14
21. Chia PY, Coleman KK, Tan YK, et al. Detection of air and surface contamination by SARS-CoV-2 in hospital rooms of infected patients. Nat Commun. 2020;11:2800. https://doi.org/10.1038/s41467-020-16670-2
22. Guo ZD, Wang ZY, Zhang SF, et al. Aerosol and Surface Distribution of Severe Acute Respiratory Syndrome Coronavirus 2 in Hospital Wards, Wuhan, China, 2020. Emerg Infect Dis. 2020;26:1583-91. https://doi.org/10.3201/eid2607.200885
23. Lednicky JA, Shankar SN, Elbadry MA, et al. Collection of SARS-CoV-2 Virus from the Air of a Clinic Within a University Student Health Care Center and Analyses of the Viral Genomic Sequence. Aerosol Air Qual Res. 2020;20:1167-71. https://doi.org/10.4209/aaqr.2020.02.0202
24. Liu Y, Ning Z, Chen Y, et al. Aerodynamic analysis of SARS-CoV-2 in two Wuhan hospitals. Nature. 2020;582:557-60. https://doi.org/10.1038/s41586-020-2271-3
25. Santarpia JL, Rivera DN, Herrera VL, etal. Aerosol and surface contamination of SARS-CoV-2 observed in quarantine and isolation care. Scientific Reports. 2020;10:12732. https://doi.org/10.1038/s41598-020-69286-3
26. Wilson NM, Norton A, Young FP, et al. Airborne transmission of severe acute respiratory syndrome coronavirus-2 to healthcare workers: a narrative review. Anaesthesia. 2020;75:1086-95. https://doi.org/10.1111/anae.15093
27. Fears AC, Klimstra WB, Duprex P, et al. Persistence of Severe Acute Respiratory Syndrome Coronavirus 2 in Aerosol Suspensions. Emerg Infect Dis. 2020;26. https://doi.org/10.3201/eid2609.201806
28. Lee BU. Minimum Sizes of Respiratory Particles Carrying SARS-CoV-2 and the Possibility of Aerosol Generation. Int J Environ Res Public Health. 2020;17. https://doi.org/10.3390/ijerph17196960
29. Liu DX, Liang JQ, Fung TS.nHuman Coronavirus-229E, -OC43, -NL63, and -HKU1 (Coronaviridae). Encyclopedia of Virology. 2021;428-40. https://doi.org/10.1016/B978-0-12-809633-8.21501-X
30. Vijgen L, Keyaerts E, Moes E, et al. Complete genomic sequence of human coronavirus OC43: molecular clock analysis suggests a relatively recent zoonotic coronavirus transmission event. J Virol. 2005;79:1595-604. https://doi.org/10.1128/JVI.79.3.1595-1604.2005