Development of a simple compatibility inspection method using pressure in a BD PhaSeal™ system and hazardous drug vials

Abstract

Background Many reports support the use of closed system drug transfer devices (CSTDs) to protect against exposure to hazardous drugs during their preparation. However, leakage may occur if the CSTD fails to maintain hermeticity when fitted into the vial. Our aims were to devise a measure to prevent HD exposure and to develop a test method to verify CSTD function when a BD PhaSeal™ protector is used in HD preparation. Methods We selected the BD PhaSeal™ System, which is the most commonly used CSTD device in Japan. The sealability of the BD PhaSeal™ protector and vial is considered to be due to the hermeticity of the protector and the rubber stopper of the vial. We constructed a protector with a damaged sealing rim and monitored the pressure fluctuation 10 times when the BD PhaSeal™ injector was connected to the pressurized vial. Results The reduction in pressure of the protector in the group without a damaged sealing rim was 5%, while that in the group with the damaged sealing rim was 84.9%. Conclusion It was suggested that leakage occurred through the gap between the protector and the rubber stopper when using a vial that was not in close contact with the sealing rim. In this study, we developed a test that can be easily used to verify the compatibility of the BD PhaSeal™ protector and a vial in the clinical setting. Thus, when new hazardous drugs are being prepared, these measures can be taken to ensure that the risk of exposure is reduced or eliminated.

Pressure Compatibility Test of Closed System Drug Transfer Devices for 71 Anticancer Drugs

“…14 16,19,28) When determining the compatibility between hazardous drugs and protectors, the diameter and height of the rubber stopper is measured, and whether it is within the speciˆcations of the protector is evaluated. 21) Few studies have examined the leakage of hazardous drugs during preparation. In our study, the pressure ‰uctuation in the vial was monitored over time when the CSTD was repeatedly connected and disconnected 10 times (corresponding to draining the drug solution in the vial 10 times), and the compatibility between the anticancer drug vial and protector was monitored.…”

“…However, a previous study found that the expansion bladder could be safely pressurized to 100 kPa after it had fully expanded. 21) By pressurizing the inside of the vial, even a very small leak that could not otherwise be measured by the built-in pressure gauge can be detected as a pressure leak by the pressure gauge. This allows thè`n othing in, nothing out'' requirement that is critical to the function of CSTDs to be tested.…”

“…In the present study, we used this method to investigate the hermeticity of protectors and vials for domestically marketed anti-cancer drug vials in Japan, and constructed a database of compatibility between anti-cancer drug vials and protectors. 21)…”

Source apportionment and quantification of liquid and headspace leaks from closed system drug-transfer devices via Selected Ion Flow Tube Mass Spectrometry (SIFT-MS)

“…Hydrogen gas was used as a leak agent as a measure of the gas-tight seal of CSTDs by Besheer et al [12]. Pressure compatibility by Ishimaru et al showed that pressure testing could reveal headspace leaks [20,21].…”

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“…Hydrogen gas was used as a leak agent as a measure of the gas-tight seal of CSTDs by Besheer et al [12]. Pressure compatibility by Ishimaru et al showed that pressure testing could reveal headspace leaks [20,21].…”