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Abstract
Background Phial sharing would lead to great savings in cancer therapy. Although physicochemical data support this practice frequently, microbiological stability is of concern.
Purpose To assess microbiological stability of vials in cytostatic compounding when a closed-system drug transfer device (CSTD) is used.
Materials and methods Cytostatic compounding process was simulated using 100 ml TSB culture media vials. Three batches (eight vials each) were elaborated by different technicians. Handling was conducted inside a biological safety cabinet and using PhaSeal system (CSTD). Usual garbing for cytostatic compounding was used. At day zero, vials were diluted (5 ml of sterile water). Thereafter, on days 1, 4, and 7, seven millilitres of phial content were removed using a 10 ml syringe and 13 ml were transferred to a 100 ml empty bag. Vials were stored outside the clean room. Work surface and gloves were sampled at the end of each day by applying Tryptic Soy Agar (TSA) contact plates. All samples were incubated for two weeks (20-25°). Contamination was defined as visual turbidity. Contact plates were incubated one week at 37°.
Results No microbiological growth was detected in any of the 24 vials after 7 days of storage and 9 manipulations of each phial. 96 syringes and 96 bags were incubated. None were contaminated either. Samples from the work surface remained clean. Only one plate from the gloves was contaminated with two colony-forming units of gram positive cocci. Microorganisms did not reach the solution supporting the fact that PhaSeal® encourages a proper aseptic technique. Absence of contamination after storage and handling has also been reported previously using traditional needle-based methods. However, the use of CSTD as in our study represents best current practice in cytostatic compounding where operator protection is a cornerstone.
Conclusions An aseptic technique using PhaSeal® maintains phial's sterility over time and handling, allowing substantial savings. Results will be validated in a larger study that is ongoing.