Cytotoxic contamination level follow-up during the implementation of an automated compounding system

8 octobre 2015

N. Creus1, C. Lopez Cabezas1, M. Oliveras2, G. Cajaraville3, N. Telleria4 1 Hospital Clinic, Barcelona
2 Hospital Vall d’Hebron, Barcelona
3 Onkologikoa, San Sebastian
4 KIRO Robotics S.L. Spain

The aim of the study was to assess performance of KIRO Oncology and its automated cleaning system to keep chemical contamination levels under acceptable limits, thus avoiding the need for manual cleaning.

The implementation period of KIRO Oncology lasted five months, during which between 40 and 80 cytotoxic drugs were compounded weekly. Wipe samples were taken every three weeks after cleaning. 5-Fluorouracil (5FU) and Cyclophosphamide (CYP) were evaluated in critical areas of KIRO Oncology and manual preparation areas.

To test the efficacy of four cleaning solution combinations a spiking study was carried out with 100 ng/cm² of 8 cytotoxic drugs including platins (PT).

After 470 5FU and 311 CYP preparations compounded in KIRO Oncology the critical surfaces and bag adaptors showed non-detectable (ND) levels or <0.1 ng/cm² of both 5FU and CYP. Vial and syringe adaptors levels ranged from ND to 0.14 ng/cm² for 5FU and 0.07 to 0.85 ng/cm² for CYP. Levels in the drain water ranged from ND to 0.2 mg/15L of 5FU and 0.02 to 0.6 mg/15L of CYP.
Manual preparation areas presented ND or <0.1 ng/cm² levels except on the scale, reaching 0.47 ng/cm² for 5FU and 0.25 ng/cm² for CYP.

Absence of cleaning detergent decontaminated all drugs except PT and CYP (1.8 and 1.7 ng/cm² respectively). Two cleaning solutions removed all drugs except PT (<1 ng/cm²) and one removed all the spiked drugs (ND to <0.1 ng/cm².

KIRO Oncology performed reliably as a technology to efficiently decontaminate below acceptable limits. This can contribute to time savings and to avoid risks associated with manual cleaning.
Different cleaning solutions are supported by the system to address particular decontamination needs.

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