Prevention of Coronavirus Contamination from the Environment Using an Air-cleaning Closed System Drug-transfer Device

Overview

Journal Pharm Pract (Granada)

Date 2022 Apr 27

PMID 35474646

Authors

Maya Amichay

Ortal Shimon

Eitan Raveh

Affiliations

Soon will be listed here.

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: Chemfort™ 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.

References

Vijgen L, Keyaerts E, Moes E, Thoelen I, Wollants E, Lemey P . Complete genomic sequence of human coronavirus OC43: molecular clock analysis suggests a relatively recent zoonotic coronavirus transmission event. J Virol. 2005; 79(3):1595-604. PMC: 544107. DOI: 10.1128/JVI.79.3.1595-1604.2005. View

Guo Z, Wang Z, Zhang S, Li X, Li L, Li C . Aerosol and Surface Distribution of Severe Acute Respiratory Syndrome Coronavirus 2 in Hospital Wards, Wuhan, China, 2020. Emerg Infect Dis. 2020; 26(7):1583-1591. PMC: 7323510. DOI: 10.3201/eid2607.200885. View

Fears A, Klimstra W, Duprex P, Hartman A, Weaver S, Plante K . Persistence of Severe Acute Respiratory Syndrome Coronavirus 2 in Aerosol Suspensions. Emerg Infect Dis. 2020; 26(9). PMC: 7454081. DOI: 10.3201/eid2609.201806. View

Sessink P, Connor T, Jorgenson J, Tyler T . Reduction in surface contamination with antineoplastic drugs in 22 hospital pharmacies in the US following implementation of a closed-system drug transfer device. J Oncol Pharm Pract. 2010; 17(1):39-48. PMC: 4627487. DOI: 10.1177/1078155210361431. View

Besheer A, Burton L, Galas Jr R, Gokhale K, Goldbach P, Hu Q . An Industry Perspective on Compatibility Assessment of Closed System Drug-Transfer Devices for Biologics. J Pharm Sci. 2020; 110(2):610-614. DOI: 10.1016/j.xphs.2020.10.047. View

Vonberg R, Gastmeier P . Hospital-acquired infections related to contaminated substances. J Hosp Infect. 2006; 65(1):15-23. DOI: 10.1016/j.jhin.2006.09.018. View

Sessink P, Nyulasi T, Haraldsson E, Rebic B . 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(4):459-467. DOI: 10.1093/annweh/wxz010. View

Bartel S, Tyler T, Power L . 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(4):199-211. DOI: 10.2146/ajhp160948. View

Lednicky J, Shankar S, Elbadry M, Gibson J, Alam M, Stephenson C . 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. 2021; 20(6):1167-1171. PMC: 7792982. DOI: 10.4209/aaqr.2020.02.0202. View

10.

Macias A, Ponce de Leon S, Huertas M, Maravilla E, Romero C, Montoya T . Endemic infusate contamination and related bacteremia. Am J Infect Control. 2008; 36(1):48-53. DOI: 10.1016/j.ajic.2007.02.003. View

11.

Santarpia J, Rivera D, Herrera V, Morwitzer M, Creager H, Santarpia G . Aerosol and surface contamination of SARS-CoV-2 observed in quarantine and isolation care. Sci Rep. 2020; 10(1):12732. PMC: 7391640. DOI: 10.1038/s41598-020-69286-3. View

12.

Valero S, Lopez-Briz E, Vila N, Solana A, Melero M, Poveda J . 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; 95:1-7. DOI: 10.1016/j.yrtph.2018.03.001. View

13.

Liu Y, Ning Z, Chen Y, Guo M, Liu Y, Gali N . Aerodynamic analysis of SARS-CoV-2 in two Wuhan hospitals. Nature. 2020; 582(7813):557-560. DOI: 10.1038/s41586-020-2271-3. View

14.

Hernandez-Ramos I, Gaitan-Meza J . Extrinsic contamination of intravenous infusates administered to hospitalized children in Mexico. Pediatr Infect Dis J. 2000; 19(9):888-90. DOI: 10.1097/00006454-200009000-00017. View

15.

Levin G, Sessink P . Validation of chemotherapy drug vapor containment of an air cleaning closed-system drug transfer device. J Oncol Pharm Pract. 2021; 28(7):1508-1515. PMC: 9465531. DOI: 10.1177/10781552211030682. View

16.

Muller A, Huisman I, Roos P, Rietveld A, Klein J, Harbers J . Outbreak of severe sepsis due to contaminated propofol: lessons to learn. J Hosp Infect. 2010; 76(3):225-30. DOI: 10.1016/j.jhin.2010.06.003. View

17.

Soubieux A, Tanguay C, Bussieres J . Review of studies examining microbial contamination of vials used for preparations done with closed-system drug transfer devices. Eur J Hosp Pharm. 2021; 28(2):65-70. PMC: 7907703. DOI: 10.1136/ejhpharm-2019-001913. View

18.

Azhar E, Hashem A, El-Kafrawy S, Sohrab S, Aburizaiza A, Farraj S . 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(4):e01450-14. PMC: 4120199. DOI: 10.1128/mBio.01450-14. View

19.

Harrison B, Peters B, Bing M . 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(18):1736-44. DOI: 10.2146/ajhp050258. View

20.

Chia P, Coleman K, Tan Y, Ong S, Gum M, Lau S . Detection of air and surface contamination by SARS-CoV-2 in hospital rooms of infected patients. Nat Commun. 2020; 11(1):2800. PMC: 7260225. DOI: 10.1038/s41467-020-16670-2. View