{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T04:01:13Z","timestamp":1788321673092,"version":"build-2803163510"},"reference-count":22,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2024,12,10]],"date-time":"2024-12-10T00:00:00Z","timestamp":1733788800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2024,12,10]],"date-time":"2024-12-10T00:00:00Z","timestamp":1733788800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100017412","name":"BD","doi-asserted-by":"publisher","award":["CyberGrant #\/Project: 76223579"],"award-info":[{"award-number":["CyberGrant #\/Project: 76223579"]}],"id":[{"id":"10.13039\/100017412","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Oncol Pharm Pract"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>The purpose of this study was to assess and compare the effectiveness of seven different closed system transfer device (CSTD) product lines following the 2015 NIOSH Vapor Containment Performance Protocol, using a Gasmet\u2122 DX5000 Terra multigas FTIR analyzer.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Seven different CSTD systems were assessed using a two-task evaluation on their capacity to contain the NIOSH-specified challenge agent, 70% isopropyl alcohol (IPA). Task 1 simulated reconstitution and compounding steps while Task 2 simulated compounding and administration steps. Vial adapters, syringe adapters, IV bag adapters, and y-site adapters from each CSTD product line were tested. All tasks were performed in a custom-built environmental test chamber as outlined in the 2015 NIOSH protocol, with isopropyl alcohol (IPA) release detected and measured by a Gasmet\u2122 analyzer.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The BD PhaSeal\u2122 CSTD product line effectively contained IPA vapor during both tasks with a task performance metric of 0.00\u2005ppm for each task. BD PhaSeal\u2122 Optima, Equashield\n                      <jats:sup>\u00ae<\/jats:sup>\n                      , Yukon Medical Arisure\n                      <jats:sup>\u00ae<\/jats:sup>\n                      , ICU Medical ChemoLock\u2122, BD Texium\u2122, and ICU Medical ChemoClave\u2122 non-vented CSTDs demonstrated detectable and quantifiable IPA leakage during each task. The leaks occurred at different steps within the protocol, and the amount of IPA vapor detected varied.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In this study, one CSTD product line (i.e., PhaSeal\u2122) successfully contained IPA vapor below the Gasmet\u2122 analyzer's limit of quantification (LOQ) for IPA of 0.04\u2005ppm for both Tasks 1 and 2, demonstrating it to be a validated closed system per the study protocol. All other CSTD product lines demonstrated some level of IPA leakage with task performance metrics above the analyzer's LOQ. However, these results tell us little about how well CSTDs contain hazardous drugs (HDs), as a universal HD surrogate for effectively assessing the closedness of all types of CSTDs has yet to be identified.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10781552241304638","type":"journal-article","created":{"date-parts":[[2024,12,10]],"date-time":"2024-12-10T06:24:55Z","timestamp":1733811895000},"page":"632-640","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["An assessment of seven closed system transfer devices in accordance with the 2015 NIOSH vapor containment performance protocol"],"prefix":"10.1177","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4680-0156","authenticated-orcid":false,"given":"Lori T.","family":"Armistead","sequence":"first","affiliation":[{"name":"University of North Carolina at Chapel Hill Eshelman School of Pharmacy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Stepanovic","sequence":"additional","affiliation":[{"name":"University of North Carolina at Chapel Hill Eshelman School of Pharmacy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan A.","family":"Earnhart","sequence":"additional","affiliation":[{"name":"University of North Carolina at Chapel Hill Eshelman School of Pharmacy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen F.","family":"Eckel","sequence":"additional","affiliation":[{"name":"University of North Carolina at Chapel Hill Eshelman School of Pharmacy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,12,10]]},"reference":[{"key":"e_1_3_5_2_2","doi-asserted-by":"publisher","DOI":"10.1177\/001857879903401110"},{"key":"e_1_3_5_3_2","first-page":"1","article-title":"The evolution of the CSTD","volume":"12","author":"Massoomi F","year":"2015","unstructured":"Massoomi F. The evolution of the CSTD. Pharm Purch Prod 2015; 12: 1. https:\/\/www.pppmag.com\/article\/1638","journal-title":"Pharm Purch Prod"},{"key":"e_1_3_5_4_2","unstructured":"Hirst D Mead K. A vapor containment performance protocol for closed system transfer devices used during pharmacy compounding and administration of hazardous drugs: Draft. National Institute for Occupational Safety and Health. August 2015 https:\/\/www.cdc.gov\/niosh\/docket\/review\/docket288\/pdfs\/a-vapor-containment-performance-protocol-for-closed-system-transfer-devices.pdf (2015 accessed 7 November 2024)."},{"key":"e_1_3_5_5_2","unstructured":"Hospital Pharmacy Europe website. Barrier-based CSTD versus filter-based systems: A review https:\/\/hospitalpharmacyeurope.com\/clinical-zones\/oncology\/barrier-based-cstd-versus-filter-based-systems-a-review\/ (10 December 2018 accessed 7 November 2024)."},{"key":"e_1_3_5_6_2","unstructured":"Clark C. Understanding closed system transfer devices. Hospital Pharmacy Europe website. 2017; 85 https:\/\/hospitalpharmacyeurope.com\/clinical-zones\/medicines-safety\/understanding-closed-system-transfer-devices\/ (9 May 2017 accessed 7 November 2024)."},{"key":"e_1_3_5_7_2","first-page":"10","article-title":"Guidelines for CSTD evaluation and implementation","volume":"20","author":"Shay B","year":"2023","unstructured":"Shay B, Eckel SF. Guidelines for CSTD evaluation and implementation. Pharm Purch Prod 2023; 20: 10. https:\/\/www.pppmag.com\/article\/3033","journal-title":"Pharm Purch Prod"},{"key":"e_1_3_5_8_2","volume-title":"Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings","author":"NIOSH","year":"2004","unstructured":"NIOSH. Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004\u2013165, https:\/\/www.cdc.gov\/niosh\/docs\/2004-165\/default.html (2004, accessed November 7, 2024)."},{"key":"e_1_3_5_9_2","unstructured":"The U.S. Pharmacopeia (USP). USP general chapter <800>: Hazardous drugs\u2014handling in healthcare settings www.usp.org\/compounding\/general-chapter-hazardous-drugs-handling-healthcare (accessed 7 November 2024)."},{"key":"e_1_3_5_10_2","doi-asserted-by":"publisher","DOI":"10.1177\/1078155213498630"},{"issue":"4","key":"e_1_3_5_11_2","first-page":"18","article-title":"State regulations impact USP <797>compliance","volume":"9","author":"Douglass K","year":"2012","unstructured":"Douglass K, Kastango E, Cantor P. State regulations impact USP <797>compliance. Pharm Purch & Prod 2012; 9(4): 18. https:\/\/www.pppmag.com\/article\/3033","journal-title":"Pharm Purch & Prod"},{"key":"e_1_3_5_12_2","unstructured":"Department of Health and Human Services. Docket Number CDC\u20132015\u20130075; NIOSH\u2013 288. Request for information on development of a performance test protocol for closed system transfer devices that incorporate air-cleaning technology to provide worker protection during pharmacy compounding and administration of hazardous drugs https:\/\/www.cdc.gov\/niosh\/docket\/review\/docket288\/pdfs\/federalregisternotice2016-00827.pdf (2015 accessed November 7 2024)."},{"key":"e_1_3_5_13_2","unstructured":"Department of Health and Human Services. Docket Number CDC\u20132016\u20130090; NIOSH\u2013 288-A. A vapor containment performance protocol for closed system transfer devices used during pharmacy compounding and administration of hazardous drugs https:\/\/www.cdc.gov\/niosh\/docket\/review\/docket288a\/pdfs\/288-afrnotice9-15-16.pdf (2016 accessed 7 November 2024)."},{"key":"e_1_3_5_14_2","first-page":"148","article-title":"Safe cytotoxic drug preparation using closed-system transfer device: technical and practical evaluation of a new device (vialshield\/texium) comparatively to a reference on (phaseal)","volume":"20","author":"Garrigue P","year":"2016","unstructured":"Garrigue P, Montana M, Ventre C, et al. Safe cytotoxic drug preparation using closed-system transfer device: technical and practical evaluation of a new device (vialshield\/texium) comparatively to a reference on (phaseal). IJPC 2016; 20: 148\u2013154.","journal-title":"IJPC"},{"key":"e_1_3_5_15_2","doi-asserted-by":"publisher","DOI":"10.1310\/hpj4309-723"},{"key":"e_1_3_5_16_2","doi-asserted-by":"publisher","DOI":"10.2146\/ajhp110678"},{"key":"e_1_3_5_17_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0205263"},{"key":"e_1_3_5_18_2","doi-asserted-by":"publisher","DOI":"10.1039\/D2AY01128J"},{"issue":"4","key":"e_1_3_5_19_2","article-title":"Containment performance assessment of closed system transfer devises (CSTDs) using the NIOSH draft protocol and TEU as surrogate. Abstract #10","volume":"24","author":"Wilkinson AS","year":"2018","unstructured":"Wilkinson AS, Allwood MC, Morris CP, et al. Containment performance assessment of closed system transfer devises (CSTDs) using the NIOSH draft protocol and TEU as surrogate. Abstract #10. 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