Frequently Asked Questions

How does the process ensure segregation of Cytotoxic and Cytostatic material? Do they go on the same conveyor belt?

Cytotoxic and Cytostatic waste is segregated from all other sharps waste streams during disposal. When processing all sharps waste streams, a specific 770l UN3291 compliant waste container is placed beneath the robotic decanting head. The 770l units are filled to around 75% capacity then changed. The sharps waste processed is segregated in accordance with HTM 0701 (safe management of healthcare waste) guidance and all other relevant waste disposal and transport standards. When a clean cytotoxic or cytostatic process is run, the manufacturing grade cyto hood is placed around the decanting head and the extraction fan started. This ensures that any aerosol generated during the decanting process is directed through a HEPA filter, which is monitored and alarmed if the validation pressure is either lower or higher than the processing requirements. All containers are loaded onto the same machine infeed conveyor and they are not unlocked or opened until they reach the robotic head which is inside the negative pressure cyto hood. The cytotoxic and cytostatic cleaning, handling and waste water disposal processes were developed utilising a risk control planning methodology which was reviewed by the health and safety labs in the UK. This provided validation that the process presented no harm to the operators, the environment and the downstream users of the container. Swab testing was performed and independently analysed to validated the washsmart cleaning process.

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