PP-038 Combining a closed system transfer device and an improved decontamination process to decrease the contamination inside isolators. (25th February 2017) - Vasseur, M
Abstract : Background: Despite 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. Purpose: This study aimed to assess the decontamination efficiency inside isolators of two different decontamination processes associated with a CSTD. Material and methods: A 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. Results: The 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). Conclusion: Combining 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 acknowledgements: Simon, 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.