Evaluation of the surface antineoplastic contamination of ready-to-use gemcitabine bags

Objectives

To evaluate the surface chemical contamination of ready to use gemcitabine intravenous bags by research and quantification of potential gemcitabine present on the external surfaces of the bags (immediate packaging), the exterior packaging and the IV tubing ports (before and after the introduction of an infuser).

Materials and Methods

The surfaces of 6 bags of 120 mL and 6 bags of 220 mL of ready to use 10 mg/mL gemcitabine bags (12 sampling sites for each bag), the exterior aluminium packaging (10 sampling sites each) and the IV tubing ports (before and after infuser introduction) were swiped using sterile cellulose absorbent paper. In total, the whole surface of the bags and aluminium wrapping were sampled. The collected gemcitabine was then recovered for analysis using a validated HPLC-UV quantification method, with a limit of quantification determined as being of 50 ng/mL, corresponding to a quantity of 100 ng of gemcitabine per 25 cm², i.e. 4 ng/cm², and a limit of detection of 10 ng/mL (quantity of 20 ng of gemcitabine per 25 cm², i.e. 0.8 ng/cm²)

Results

Gemcitabine was detected as least once per unit on the surface of the aluminium external packaging (on 1 to 6 sampling sites out of 10), with contaminations ranging from <4 ng/cm² to 469.4 ng/cm² per sampling site. In comparison the immediate packaging bag surfaces were less contaminated: gemcitabine was detected as least once per unit but on less sampling sites (on 1 to 3 sampling sites out of 12 per unit), and overall quantities were less important (contaminations ranging from <4 ng/cm² to 14.65 ng/cm² per sampling site. Before infuser introduction, the IV sampling site showed contaminations ranging from 4.15 to 10.53 ng/cm² (3 sites of 6 and 6 sites out of 6 for respectively the 120 mL and 220 mL bags), and after infuser introduction only one site for each bag volume showed any signs of contamination, however the quantities detected were a lot higher (52.03 and 132.64 ng/cm² for the 120 and 220 mL bags, respectively).

Discussion-conclusion

All surfaces showed seemingly random distribution of gemcitabine contaminations. No specific location or type of bag or surface could be determined. Despite some high contaminations, for most sampling sites the contamination remained at a low level, often less than 10 ng/cm². Like for other anticancer preparations, the use of protective equipment should be recommended for the handling of the bags, including when still in their aluminium exterior packaging.

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