Titre :

A decontamination process adding a tensioactive agent and isopropanol to a closed-system drug transfer device for better control of isolator contamination. A prospective, parallel study.

Auteur(s) :

Vasseur, Michele [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Simon, Nicolas [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Picher, Chloe [Auteur]
Impact de l'environnement chimique sur la santé humaine - ULR 4483 [IMPECS]
Richeval, Camille [Auteur]
Toxicologie et Génopathies [CHRU Lille]
Soichot, Marion [Auteur]
Impact de l'environnement chimique sur la santé humaine - ULR 4483 [IMPECS]
Humbert, Luc [Auteur]
Impact de l'environnement chimique sur la santé humaine - ULR 4483 [IMPECS]
Barthelemy, Christine [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Fleury-Souverain, Sandrine [Auteur]

Bonnabry, Pascal [Auteur]

Décaudin, Bertrand [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Allorge, Delphine [Auteur]
Impact de l'environnement chimique sur la santé humaine - ULR 4483 [IMPECS]
Odou, Pascal [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]

Titre de la revue :

PLoS One

Nom court de la revue :

PLoS One

Numéro :

13

Pagination :

e0201335

Date de publication :

2018

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

BACKGROUND: Despite the use of closed system drug transfer devices (CSTD), residual contamination from antineoplastic drugs is still detected inside isolators. The aim of this study was to compare the decontamination level ...
Lire la suite >BACKGROUND: Despite the use of closed system drug transfer devices (CSTD), residual contamination from antineoplastic drugs is still detected inside isolators. The aim of this study was to compare the decontamination level obtained using a CSTD + standard cleaning procedure with a CSTD + standard cleaning procedure + specific decontamination procedure. METHODS AND FINDINGS: A comparative and prospective study was carried out in a newly opened compounding unit. Compounding was performed with a CSTD (BD-Phaseal, Becton-Dickinson). In the Control isolator (C), the cleaning process was completed daily with a standard biocide solution (AnioxysprayTM, Anios, France). In the Intervention isolator (I), weekly decontamination with a homemade admixture of sodium dodecyl sulfate 10-2 M/70% isopropanol (80/20, v/v) was added. Monitoring was performed via a validated LC-MS/MS method. Eight drugs (cyclophosphamide, cytarabine, dacarbazine, fluorouracile, gemcitabine, ifosfamide, irinotecan and methotrexate) were monitored daily over 14 consecutive weeks on three sites inside the isolators: gloves, workbench and window. Results are presented as the odds-ratio (OR) of contamination and as overall decontamination efficiency (EffQ, %). The proportion of EffQ ≥ 90% was assessed by a Fisher's exact test (p<0.05). Overall contamination rates (CR, %) were significantly different from one isolator to the other (CRC = 25.3% vs. CRI = 10.4%; OR = 0.341; p<0.0001). Overall EffQ values (median; 1st and 3rd quartiles) were higher in the intervention isolator (I: 78.3% [34.6%;92.6%] vs. C: 59.5% [-5.5%;72.6%]; p = 0.0015) as well as the proportion of days with an EffQ ≥ 90% (I: 42.9% vs. C: 7.1%; p = 0.077) but very variable depending on drugs. CONCLUSION: Adding a decontamination protocol with a tensioactive agent to a CSTD leads to better control of chemical contamination inside isolators. Improving decontamination by increasing decontamination frequency or modifying the protocol will be further studied.Lire moins >

Langue :

Anglais

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

Université de Lille
CHU Lille
Institut Pasteur de Lille

Collections :

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

Équipe(s) de recherche :

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

Date de dépôt :

2019-02-26T17:06:52Z
2019-07-05T12:01:09Z
2021-06-07T09:51:51Z