Microbiological challenge of four protective devices for the reconstitution of cytotoxic agents.
OBJECTIVE
To evaluate the susceptibility to microbial contamination that occurs during simulated handling of protective devices for the preparation of cytotoxic drug solutions.


RESULTS
Four devices, i.e. Chemoprotect spike, Clave connector, PhaSeal and Securmix were challenged with low and high inocula of micro-organisms. The cells, transferred to the connected vials during repeated manipulations of the devices were counted by means of solid-phase cytometry. Of the four devices, PhaSeal afforded the lowest transfer of micro-organisms. Secondly, the efficiency of procedures for the disinfection of an artificially contaminated rubber stopper was compared prior to connection of the vial to the PhaSeal device. Spraying or swabbing alone was inadequate, as opposed to a combination of spraying [0.5% or 2.0% (w/v) chlorhexidine in isopropanol] and swabbing [70% (v/v) isopropanol].


CONCLUSIONS
Although Phaseal afforded the lowest transfer of micro-organisms, adequate disinfection of the vial prior to connection remains required.


CONCLUSIONS
Unlike aspects of operator protection, which are well documented, the microbiological safety of protective devices for the preparation of cytotoxic drugs has not been addressed in the literature. This study estimates the susceptibility to microbial contamination during handling of four commonly used devices.
De Prijck
K
K
Laboratory for Pharmaceutical Microbiology, Ghent University, Ghent, Belgium.
D'Haese
E
E
Vandenbroucke
J
J
Coucke
W
W
Robays
H
H
Nelis
H J
HJ
D001419:Bacteria / Q000187:drug effects; D003603:Cytotoxins; D004202:Disinfectants / Q000494:pharmacology; D004203:Disinfection / Q000379:methods*; D004866:Equipment Contamination / Q000706:statistics & numerical data*; D011482:Protective Devices / Q000382:microbiology*
D003603:Cytotoxins; D004202:Disinfectants