Microbiological challenge of four protective devices for the reconstitution of cytotoxic agents

Abstract

Aims: To evaluate the susceptibility to microbial contamination that occurs during simulated handling of protective devices for the preparation of cytotoxic drug solutions. Methods and 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. Significance and Impact of the Study: 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.

Economic and Microbiologic Evaluation of Single-Dose Vial Extension for Hazardous Drugs

“…After the testing of five different devices or methods used in chemotherapy preparation, one process (PhaSeal; Carmel Pharma, Columbus, OH) introduced the lowest amount of microorganisms into the vial and was statistically better than all other processes. 11 It is important to note that contamination was detected in the vial using a CSTD and increased with a larger number of couplings.…”

“…9 The implementation of CSTDs can lead to lower employee uptake and exposure to chemotherapy. 10 De Prijck et al 11 tested the concept of potential for microbiologic ingress in vials during simulated manipulations with contamination artificially placed on the stopper. After the testing of five different devices or methods used in chemotherapy preparation, one process (PhaSeal; Carmel Pharma, Columbus, OH) introduced the lowest amount of microorganisms into the vial and was statistically better than all other processes.…”

Aseptic simulation test for cytotoxic drug production in isolators

“…This isolated occurrence illustrated that the process of decontamination is particularly important, especially since manipulations are performed outside isolators, and that the use of a closed-system transfer device allows the avoidance of microbial contamination if and only if proper decontamination procedure is applied. These dictums are supported by the research of De Prijck et al, 12 who emphasized the importance of adequate disinfection of the vial prior to connection, and Thomas et al, 2 who found that the most important variable affecting microbial contamination was the aseptic technique of personnel-not the environment in which the drugs were compounded.…”

“…[12][13][14] De Prijck et al 12 found that PhaSeal afforded the lowest microbial contamination rate among four other evaluated devices. Moreover, PhaSeal is the first and only FDA-cleared closedsystem transfer device indicated for reducing exposure to hazardous drugs.…”

Microbiological Challenge Test of Contamination Caused by Using the PhaSeal System

“…Although microbiological contamination risk has been reported for the closed system when puncturing the vial with the needle, 6) bacterial contamination of the vial through the rubber stopper requires further study.…”