title: Effectiveness of a Closed-System Transfer Device in Reducing Surface Contamination in a New Antineoplastic Drug-Compounding Unit: A Prospective, Controlled, Parallel Study.
abstract: BACKGROUND
  The objective of this randomized, prospective and controlled study was to investigate the ability of a closed-system transfer device (CSTD; BD-Phaseal) to reduce the occupational exposure of two isolators to 10 cytotoxic drugs and compare to standard compounding devices.
  
  
  RESULTS
  The 6-month study started with the opening of a new compounding unit. Two isolators were set up with 2 workstations each, one to compound with standard devices (needles and spikes) and the other using the Phaseal system. Drugs were alternatively compounded in each isolator. Sampling involved wiping three surfaces (gloves, window, worktop), before and after a cleaning process. Exposure to ten antineoplastic drugs (cyclophosphamide, ifosfamide, dacarbazine, 5-FU, methotrexate, gemcitabine, cytarabine, irinotecan, doxorubicine and ganciclovir) was assessed on wipes by LC-MS/MS analysis. Contamination rates were compared using a Chi2 test and drug amounts by a Mann-Whitney test. Significance was defined for p<0.05. Overall contamination was lower in the "Phaseal" isolator than in the "Standard" isolator (12.24% vs. 26.39%; p < 0.0001) although it differed according to drug. Indeed, the contamination rates of gemcitabine were 49.3 and 43.4% (NS) for the Standard and Phaseal isolators, respectively, whereas for ganciclovir, they were 54.2 and 2.8% (p<0.0001). Gemcitabine amounts were 220.6 and 283.6 ng for the Standard and Phaseal isolators (NS), and ganciclovir amounts were 179.9 and 2.4 ng (p<0.0001).
  
  
  CONCLUSIONS
  This study confirms that using a CSTD may significantly decrease the chemical contamination of barrier isolators compared to standard devices for some drugs, although it does not eliminate contamination totally.
authors.affiliation: EA 7365 -GRITA-Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000, Lille, France.|CHU Lille, Institut de Pharmacie, F-59000, Lille, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Simon
authors.affiliation: EA 7365 -GRITA-Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000, Lille, France.|CHU Lille, Institut de Pharmacie, F-59000, Lille, France.
authors.forename: Michèle
authors.initials: M
authors.lastname: Vasseur
authors.affiliation: CHU Lille, Institut de Pharmacie, F-59000, Lille, France.
authors.forename: Marine
authors.initials: M
authors.lastname: Pinturaud
authors.affiliation: Laboratoire de Toxicologie, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, Paris, France.
authors.forename: Marion
authors.initials: M
authors.lastname: Soichot
authors.affiliation: Unité Fonctionnelle de Toxicologie, Pôle de Biologie-Pathologie-Génétique, CHRU Lille, F-59037, Lille, France.
authors.forename: Camille
authors.initials: C
authors.lastname: Richeval
authors.affiliation: Unité Fonctionnelle de Toxicologie, Pôle de Biologie-Pathologie-Génétique, CHRU Lille, F-59037, Lille, France.
authors.forename: Luc
authors.initials: L
authors.lastname: Humbert
authors.affiliation: CHU Lille, Institut de Pharmacie, F-59000, Lille, France.
authors.forename: Michèle
authors.initials: M
authors.lastname: Lebecque
authors.affiliation: CHU Lille, Institut de Pharmacie, F-59000, Lille, France.
authors.forename: Ousseini
authors.initials: O
authors.lastname: Sidikou
authors.affiliation: EA 7365 -GRITA-Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000, Lille, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Barthelemy
authors.affiliation: Pharmacy, Geneva University Hospitals and School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Geneva, Switzerland.
authors.forename: Pascal
authors.initials: P
authors.lastname: Bonnabry
authors.affiliation: Unité Fonctionnelle de Toxicologie, Pôle de Biologie-Pathologie-Génétique, CHRU Lille, F-59037, Lille, France.
authors.forename: Delphine
authors.initials: D
authors.lastname: Allorge
authors.affiliation: EA 7365 -GRITA-Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000, Lille, France.|CHU Lille, Institut de Pharmacie, F-59000, Lille, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Décaudin
authors.affiliation: EA 7365 -GRITA-Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000, Lille, France.|CHU Lille, Institut de Pharmacie, F-59000, Lille, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Odou
mesh_terms: D000970:Antineoplastic Agents / Q000737:chemistry*; D002166:Camptothecin / Q000031:analogs & derivatives / Q000737:chemistry; D003520:Cyclophosphamide / Q000737:chemistry; D003561:Cytarabine / Q000737:chemistry; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000737:chemistry; D004339:Drug Compounding / Q000379:methods*; D004340:Drug Contamination; D005472:Fluorouracil / Q000737:chemistry; D015774:Ganciclovir / Q000737:chemistry; D006801:Humans; D007069:Ifosfamide / Q000737:chemistry; D000077146:Irinotecan; D008727:Methotrexate / Q000737:chemistry; D016273:Occupational Exposure / Q000032:analysis; D011446:Prospective Studies; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D003561:Cytarabine; D003841:Deoxycytidine; D000077146:Irinotecan; D003520:Cyclophosphamide; D015774:Ganciclovir; D005472:Fluorouracil; D007069:Ifosfamide; D002166:Camptothecin; D008727:Methotrexate; D000093542:Gemcitabine