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3PC-011 Closed system transfer device based on air filtration: the drug vapour challenge
  1. G Levin
  1. Simplivia Healthcare, Research and Development, Hod Hasharon, Israel


Background and importance Chemotherapy drugs were shown to form hazardous vapours that pose a health risk to pharmacists and nurses. One of the aims of using a closed system transfer device (CSTD) is to prevent this harmful exposure. The vapour containment efficiency of air filtration CSTDs is perceived as less obvious compared with that of physical barrier based CSTDs, and therefore should be proven throughout the shelf life of these devices in order to support the claims of its instruction for use (IFU).

Aim and objectives The aim of the study was to test the drug vapour containment capacity of Chemfort, a new air filtration CSTD. The objective was to investigate if the air filter remained fully functional at the end of the shelf life (3 years). According to the IFU, the device can be used on a drug vial for a period of 7 days, and thus the study also tested the filter functionality after it was exposed to vapours of a hazardous drug for 7 days.

Material and methods The study was performed by Nextar Labs (Nes Ziona, Israel). Vial adaptors (VA) were applied on drug vials (cyclophosphamide, 5-fluouracil (5-FU)). Extreme conditions were used to generate vapours—heating to 50°C and having a nitrogen gas flow (250 mL/min) into the vial for 5 hours via the VA fluid pathway. A closed test chamber was employed for capturing drug vapours. Vapours released through the air filter were trapped, recovered and quantified using validated LC/MS/MS methods. As a positive control, parallel testing was performed using Chemfort VA from which the filter system had been removed.

Results No drug was found in any of the test samples with the intact air filter system in Chemfort VAs, either fresh, following aging for 3 years or after 7 days of exposure to drug vapours. Recovered vapour was consistently found in the positive control samples which had Chemfor VAs without a filter system. Mean±SD (n=5) levels were 69±34 and 35±20 ng for cyclophosphamide and 5-FU, respectively.

Conclusion and relevance The results confirm the efficacy of the Chemfort air filtration system, even after 7 days of exposure to drug vapour or a shelf life of 3 years.

Conflict of interest Corporate sponsored research or other substantive relationships:

The author is an employee of Simplivia Healthcare.

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