BackgroundDespite 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 findingsA 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.ConclusionAdding 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.

BackgroundDespite the use of closed system drug transfer devices (CSTDs), residual contamination by antineoplastic drugs is still retrieved inside isolators.1 Improving the chemical decontamination process has been proposed to reduce this contamination more efficiently.PurposeThis study aimed to assess the decontamination efficiency inside isolators of two different decontamination processes associated with a CSTD.Material and methodsA comparative and prospective study was performed in a new opening compounding unit. Compounding was performed with a CSTD (BD-Phaseal, Becton-Dickinson). 8 drugs (cyclophosphamide, cytarabine, dacarbazine, fluorouracil, gemcitabine, ifosfamide, irinotecan and methotrexate) were monitored daily for 14 consecutive weeks in 3 locations inside the isolators: gloves, workbench and window. Drugs were alternatively compounded in one or the other isolator on even and odd days. In one isolator (C), the cleaning process was performed daily with a standard biocide solution (Anioxyspray, Anios). In the other (I), a weekly decontamination with an admixture of sodium dodecyl sulfate 10-2 M/isopropanol (70/30) was added.2 Monitoring was performed by a validated LC-MS/MS method.The results are presented as OR of contamination between the two groups and as overall decontamination efficiency (EffQ%) in each group. This latter parameter was computed according to Anastasi, as follows: EffQ=1–(sum of all contaminations after decontamination process (ng)/sum of all contaminations before decontamination process (ng)). The proportion of EffQ >90% was compared using Fisher’s exact test.ResultsThe overall contamination rates (CR) after the daily cleaning/decontamination process were significantly different between the two groups: CRC=25.3% versus CRI=10.4% (OR=0.341; p<0.0001). The mean overall EffQ was significantly higher in the intervention group (I: 61.0±41.5% vs C: 42.4±37.3%), but was very variable depending on the drug analysed. Decontamination was more effective for both cyclophosphamide and gemcitabine. The proportion of days with an EffQ >90% was higher in the intervention group (I: 42.9% vs C: 7.1%; p=0.077).ConclusionCombining a decontamination protocol including a tensioactive agent to a CSTD leads to better control of contamination inside isolators. Improving decontamination frequency will be further studied.References and/or acknowledgementsSimon, et al. PLOS One2016.Anastasi, et al. Ann Occup Hyg2015.Conflict of interest:Corporate sponsored research or other substantive relationships: The study was funded by Becton-Dickinson laboratories. Data analysis and interpretation and the writing of all scientific communications were performed independently of the funder.