PP-038 Combining a closed system transfer device and an improved decontamination process to decrease the contamination inside isolators

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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.

Material and methods

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

Conflict of interest:

References and/or acknowledgements

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.

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