Title :

Effectiveness of a Closed-System Transfer Device in Reducing Surface Contamination in a New Antineoplastic Drug-Compounding Unit: A Prospective, Controlled, Parallel Study

Author(s) :

Simon, Nicolas [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - EA 7365
Vasseur, Michele [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - EA 7365
Pinturaud, Marine [Auteur]
Soichot, Marion [Auteur]
Richeval, Camille [Auteur]
Humbert, Luc [Auteur]
Lebecque, Michele [Auteur]
Sidikou, Ousseini [Auteur]
BARTHELEMY Christine, Christine Barthélémy [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA)-EA 7365 [GRITA]
Bonnabry, Pascal [Auteur]
Allorge, Delphine [Auteur]
IMPact de l'Environnement Chimique sur la Santé humaine (IMPECS) - EA 4483
Decaudin, Bertrand [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - EA 7365
Odou, Pascal [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - EA 7365

Journal title :

PLoS One

Abbreviated title :

PLoS One

Volume number :

11

Publication date :

2016

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

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 ...
Show more >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. METHODS AND FINDINGS: 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). CONCLUSION: 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.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
CHU Lille
Institut Pasteur de Lille

Collections :

• Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - EA 7365

Research team(s) :

Innovation/évaluation des médicaments injectables
Modélisation biopharmaceutique et pharmacocinétique
Innovation/évaluation des dispositifs médicaux de perfusion

Submission date :

2019-02-26T17:07:22Z
2019-07-05T11:58:26Z