EXPOSURE ASSESSMENT OF PHARMACEUTICAL POWDERS BASED ON AN ENVIRONMENTAL MONITORING METHOD: A PILOT STUDY

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dc.contributor.authorYildirim, Fatma Demircan
dc.contributor.authorEkmekci, Ismail
dc.date.accessioned2021-01-25T21:47:58Z
dc.date.available2021-01-25T21:47:58Z
dc.date.issued2020
dc.departmentİstanbul Ticaret Üniversitesien_US
dc.descriptionDEMIRCAN YILDIRIM, Fatma/0000-0002-9891-696Xen_US
dc.descriptionWOS:000600186300002en_US
dc.descriptionPubMed: 33107497en_US
dc.description.abstractBackground: About 8 million healthcare workers in the USA are potentially exposed to hazardous drugs or their toxic metabolites over a long period of tune despite the fact that both the Occupational Safety and Health Administration and the European Parliament recommend the monitoring of exposure among workers dealing with substances which have carcinogenic, mutagenic or toxic effects on the reproductive system. The objective of this study is to determine exposure to active pharmaceutical ingredients (APIs) among pharmaceutical industry workers, and to develop a methodology which promotes the accurate monitoring, evaluation and control of exposure to active pharmaceutical ingredients, also in compliance with good manufacturing practice. Material and Methods: The pilot study was designed in accordance with "Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice issued by the U.S. Food and Drug Administration. The samples were collected with the swab technique which was recommended in the "Validation of Cleaning Processes (7/93)" guideline. The minimum numbers of locations (N-L 9) and sampling points (N-L (T) - 63) were determined according to ISO 14644-1:2015 "Cleanrooms and Associated Controlled Environments" issued by the International Organization for Standardization. The samples were analyzed using an ultra performance liquid chromatography system, with an analytical method which was developed and validated according to "Q7A, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients" issued by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. The low limit of quantification of the employed method (17 ng/ml) enables the determination of exposure at low concentrations. Results: While contamination was detected in 43 (68.3%) of the 63 samples collected, 20 (31.7%) could not be detected. The environmental monitoring results ranged 0-15 000 ng/cm(2) and the potential risk of exposure to API was considered to be >2 g. Conclusions: The results clearly prove and reveal the magnitude of the hazard, both objectively and scientifically, when compared to the research which suggests that 10 ng/cm(2) should be considered the prohibitory risk level in quantitative terms.en_US
dc.identifier.doi10.13075/mp.5893.00999en_US
dc.identifier.endpage663en_US
dc.identifier.issn0465-5893
dc.identifier.issn2353-1339
dc.identifier.issue6en_US
dc.identifier.pmid33107497en_US
dc.identifier.scopus2-s2.0-85098602487en_US
dc.identifier.scopusqualityQ4en_US
dc.identifier.startpage649en_US
dc.identifier.urihttps://doi.org/10.13075/mp.5893.00999
dc.identifier.urihttps://hdl.handle.net/11467/4468
dc.identifier.volume71en_US
dc.identifier.wosWOS:000600186300002en_US
dc.identifier.wosqualityQ4en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherNOFER INST OCCUPATIONAL MEDICINE, SWen_US
dc.relation.ispartofMEDYCYNA PRACYen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectenvironmental monitoringen_US
dc.subjectoccupational safety in the pharmaceutical industryen_US
dc.subjectrisk assessmenten_US
dc.subjectworking environment measurementen_US
dc.subjectexposure to APIen_US
dc.subjectdetermination of surface contaminationen_US
dc.titleEXPOSURE ASSESSMENT OF PHARMACEUTICAL POWDERS BASED ON AN ENVIRONMENTAL MONITORING METHOD: A PILOT STUDYen_US
dc.typeArticleen_US

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