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Wyszukujesz frazę "surface contamination" wg kryterium: Temat

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    Wyświetlanie 1-2 z 2
    Tytuł:
    Occupational exposure to antineoplastic drugs in hospital environments: potential risk associated with contact with cyclophosphamide- and ifosfamide-contaminated surfaces
    Autorzy:
    Mucci, Nicola
    Dugheri, Stefano
    Farioli†, Andrea
    Garzaro, Giacomo
    Rapisarda, Venerando
    Campagna, Marcello
    Bonari, Alessandro
    Arcangeli, Giulio
    Powiązania:
    https://bibliotekanauki.pl/articles/2085717.pdf
    Data publikacji:
    2020-09-24
    Wydawca:
    Instytut Medycyny Pracy im. prof. dra Jerzego Nofera w Łodzi
    Tematy:
    occupational exposure
    cyclophosphamide
    antineoplastic drugs
    ifosfamide
    wipe test
    surface contamination
    Opis:
    BackgroundCyclophosphamide (CP) and ifosfamide (IP) contaminations have been detected in hospital environments. This study was conducted to determine if there was any contamination in the spaces (floors and door handles) between the hospital exit and the antineoplastic drugs (ADs) preparation and administration units. At the same time, the authors proposed a new automation of the analytical procedure to considerably decrease the time needed for sample preparation and analysis.Material and MethodsTo evaluate the ADs contamination of surfaces, 829 wipe tests were performed in a campaign involving 3 hospitals located in Italy. Sampling was performed using an innovative kit. The levels of ADs were measured in each wipe sample using liquid chromatography/triple quadrupole.ResultsOn-line solid-phase extraction guarantees the construction of a robust and reproducible analytical method. The CP and IP recoveries from stainless steel, polycarbonate and polyvinyl chloride ranged >80%, and the wipe holders and the automation tested ensured desorption efficiencies close to 100% for both the ADs. Of the 552 wipes taken on the spaces between the hospital exit and the preparation, administration and pharmacy warehouse units, 22 were greater than or equal to the limit of quantification, all adjacent to the administration units.ConclusionsThis study provides an insight into the exposure situation against ADs residues. In order to improve environmental monitoring programs, the authors propose to evaluate the ADs contamination also outside the preparation, administration and pharmacy warehouse units.
    Źródło:
    Medycyna Pracy; 2020, 71, 5; 519-529
    0465-5893
    2353-1339
    Pojawia się w:
    Medycyna Pracy
    Dostawca treści:
    Biblioteka Nauki
    Artykuł
    Tytuł:
    Exposure assessment of pharmaceutical powders based on an environmental monitoring method: a pilot study
    Autorzy:
    Demircan Yildirim, Fatma
    Ekmekci, Ismail
    Powiązania:
    https://bibliotekanauki.pl/articles/2087446.pdf
    Data publikacji:
    2020-12-03
    Wydawca:
    Instytut Medycyny Pracy im. prof. dra Jerzego Nofera w Łodzi
    Tematy:
    environmental monitoring
    occupational safety in the pharmaceutical industry
    risk assessment
    working environment measurement
    exposure to API
    determination of surface contamination
    Opis:
    BackgroundAbout 8 million healthcare workers in the USA are potentially exposed to hazardous drugs or their toxic metabolites over a long period of time 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 MethodsThe 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 (NL = 9) and sampling points (NL(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.ResultsWhile 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/cm2 and the potential risk of exposure to API was considered to be >2 g.ConclusionsThe results clearly prove and reveal the magnitude of the hazard, both objectively and scientifically, when compared to the research which suggests that 10 ng/cm2 should be considered the prohibitory risk level in quantitative terms.
    Źródło:
    Medycyna Pracy; 2020, 71, 6; 649-663
    0465-5893
    2353-1339
    Pojawia się w:
    Medycyna Pracy
    Dostawca treści:
    Biblioteka Nauki
    Artykuł
      Wyświetlanie 1-2 z 2

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