Cargando…

Validation of chemotherapy drug vapor containment of an air cleaning closed-system drug transfer device

PURPOSE: The purpose of this study was to test the efficacy of ChemfortTM, an air filtration closed-system drug transfer device to prevent release of chemotherapy drug vapors and aerosols under extreme conditions. The air cleaning system is based on the adsorption of drug vapors by an activated carb...

Descripción completa

Detalles Bibliográficos
Autores principales: Levin, Galit, Sessink, Paul JM
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9465531/
https://www.ncbi.nlm.nih.gov/pubmed/34229499
http://dx.doi.org/10.1177/10781552211030682
_version_ 1784787818539646976
author Levin, Galit
Sessink, Paul JM
author_facet Levin, Galit
Sessink, Paul JM
author_sort Levin, Galit
collection PubMed
description PURPOSE: The purpose of this study was to test the efficacy of ChemfortTM, an air filtration closed-system drug transfer device to prevent release of chemotherapy drug vapors and aerosols under extreme conditions. The air cleaning system is based on the adsorption of drug vapors by an activated carbon filter in the Vial Adaptor before the air is released out of the drug vial. The functionality of the carbon filter was also tested at the end of device’s shelf life, and after a contact period with drug vapors for 7 days. Cyclophosphamide and 5-fluorouracil were the chemotherapy drugs tested. METHODS: The Vial Adaptor was attached to a drug vial and both were placed in a glass vessel. A needle was punctured through the vessel stopper and the Vial Adaptor septum to allow nitrogen gas to flow into the vial and to exit the vial via the air filter into the glass vessel which was connected to a cold trap. Potential contaminated surfaces in the trap system were wiped or rinsed to collect the escaped drug. Samples were analyzed using liquid chromatography tandem mass spectrometry. RESULTS: Cyclophosphamide and 5-fluorouracil were detected on most surfaces inside the trap system for all Vial Adaptors without an activated carbon filter. Contamination did not differ between the Vial Adaptors with and without membrane filter indicating no effect of the membrane filter. The results show no release of either drug for the Vial Adaptors with an activated carbon filter even after 3 years of simulated aging and 7 days of exposure to drug vapors. CONCLUSIONS: Validation of air cleaning CSTDs is important to secure vapor and aerosol containment of chemotherapy and other hazardous drugs. The presented test method has proven to be appropriate for the validation of ChemfortTM Vial Adaptors. No release of cyclophosphamide and 5- fluorouracil was found even for Vial Adaptors after 3 years of simulated aging and 7 days of exposure to drug vapors.
format Online
Article
Text
id pubmed-9465531
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher SAGE Publications
record_format MEDLINE/PubMed
spelling pubmed-94655312022-09-13 Validation of chemotherapy drug vapor containment of an air cleaning closed-system drug transfer device Levin, Galit Sessink, Paul JM J Oncol Pharm Pract Original Articles PURPOSE: The purpose of this study was to test the efficacy of ChemfortTM, an air filtration closed-system drug transfer device to prevent release of chemotherapy drug vapors and aerosols under extreme conditions. The air cleaning system is based on the adsorption of drug vapors by an activated carbon filter in the Vial Adaptor before the air is released out of the drug vial. The functionality of the carbon filter was also tested at the end of device’s shelf life, and after a contact period with drug vapors for 7 days. Cyclophosphamide and 5-fluorouracil were the chemotherapy drugs tested. METHODS: The Vial Adaptor was attached to a drug vial and both were placed in a glass vessel. A needle was punctured through the vessel stopper and the Vial Adaptor septum to allow nitrogen gas to flow into the vial and to exit the vial via the air filter into the glass vessel which was connected to a cold trap. Potential contaminated surfaces in the trap system were wiped or rinsed to collect the escaped drug. Samples were analyzed using liquid chromatography tandem mass spectrometry. RESULTS: Cyclophosphamide and 5-fluorouracil were detected on most surfaces inside the trap system for all Vial Adaptors without an activated carbon filter. Contamination did not differ between the Vial Adaptors with and without membrane filter indicating no effect of the membrane filter. The results show no release of either drug for the Vial Adaptors with an activated carbon filter even after 3 years of simulated aging and 7 days of exposure to drug vapors. CONCLUSIONS: Validation of air cleaning CSTDs is important to secure vapor and aerosol containment of chemotherapy and other hazardous drugs. The presented test method has proven to be appropriate for the validation of ChemfortTM Vial Adaptors. No release of cyclophosphamide and 5- fluorouracil was found even for Vial Adaptors after 3 years of simulated aging and 7 days of exposure to drug vapors. SAGE Publications 2021-07-06 2022-10 /pmc/articles/PMC9465531/ /pubmed/34229499 http://dx.doi.org/10.1177/10781552211030682 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Original Articles
Levin, Galit
Sessink, Paul JM
Validation of chemotherapy drug vapor containment of an air cleaning closed-system drug transfer device
title Validation of chemotherapy drug vapor containment of an air cleaning closed-system drug transfer device
title_full Validation of chemotherapy drug vapor containment of an air cleaning closed-system drug transfer device
title_fullStr Validation of chemotherapy drug vapor containment of an air cleaning closed-system drug transfer device
title_full_unstemmed Validation of chemotherapy drug vapor containment of an air cleaning closed-system drug transfer device
title_short Validation of chemotherapy drug vapor containment of an air cleaning closed-system drug transfer device
title_sort validation of chemotherapy drug vapor containment of an air cleaning closed-system drug transfer device
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9465531/
https://www.ncbi.nlm.nih.gov/pubmed/34229499
http://dx.doi.org/10.1177/10781552211030682
work_keys_str_mv AT levingalit validationofchemotherapydrugvaporcontainmentofanaircleaningclosedsystemdrugtransferdevice
AT sessinkpauljm validationofchemotherapydrugvaporcontainmentofanaircleaningclosedsystemdrugtransferdevice