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

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 proce...

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Bibliographic Details
Published in:PloS one 2018-08, Vol.13 (8), p.e0201335-e0201335
Main Authors: Vasseur, Michèle, Simon, Nicolas, Picher, Chloé, Richeval, Camille, Soichot, Marion, Humbert, Luc, Barthélémy, Christine, Fleury-Souverain, Sandrine, Bonnabry, Pascal, Décaudin, Bertrand, Allorge, Delphine, Odou, Pascal
Format: Article
Language:English
Subjects:
2-Propanol - chemistry
5-Fluorouracil
Admixtures
Antineoplastic Agents - chemistry
Antineoplastic drugs
Biocides
Chemical contamination
Chemical pollution
Cleaning
Cleaning process
Compounding
Contamination
Cyclophosphamide
Cytarabine
Cytotoxicity
Dacarbazine
Decontamination
Decontamination - methods
Drug delivery devices
Drug stores
Drugs
Gemcitabine
Gloves
Health care
Hospitals
Ifosfamide
Intervention
Irinotecan
Isolators
Isopropanol
Life Sciences
Maintenance and repair
Medical personnel
Medical research
Medicine and Health Sciences
Methods
Methotrexate
Organic chemistry
People and Places
Pharmaceutical sciences
Pharmacy
Physical Sciences
Pollution control
Prospective Studies
Quartiles
Social Sciences
Sodium
Sodium dodecyl sulfate
Sodium Dodecyl Sulfate - chemistry
Sodium lauryl sulfate
Studies
Surfactants
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Summary: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. 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
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0201335