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

2020 ◽  
pp. 107815522095251
Author(s):  
Hiromasa Ishimaru ◽  
Yasumasa Tsuda ◽  
Hidenori Kage ◽  
Tomoaki Kawano ◽  
Shinji Takayama ◽  
...  
Keyword(s):  
Closed System ◽  
Pressure Fluctuation ◽  
Clinical Setting ◽  
Close Contact ◽  
Test Method ◽  
Rubber Stopper ◽  
Inspection Method ◽  
Drug Transfer ◽  
Risk Of Exposure ◽  
Hazardous Drugs

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.

Determining Sources of Workplace Contamination with Antineoplastic Drugs and Comparing Conventional IV Drug Preparation with a Closed System

2003 ◽  
Vol 38 (2) ◽  
pp. 135-139 ◽  
Author(s):  
Susan Spivey ◽  
Thomas H. Connor
Keyword(s):  
Work Environment ◽  
Health Care Workers ◽  
Closed System ◽  
Uv Light ◽  
Drug Preparation ◽  
Antineoplastic Drugs ◽  
Dry Powder ◽  
Care Workers ◽  
Risk Of Exposure ◽  
Hazardous Drugs

Many procedures involved in the preparation and administration of hazardous drugs put health care workers at risk of exposure to these agents through leakage or accidental spills. The first objective of this study was to determine if the conventional needle/syringe technique has the potential to allow drugs to escape into the environment. The second objective was to evaluate if a closed system, PhaSeal, prevents inadvertent release of hazardous drugs. Fluorescein, a fluorescent indicator, was prepared as a dry powder and a 0.05% solution in empty drug vials. Each phase of the manipulation was photographed using UV light to visualize fluorescein leaks and spills. The procedures included reconstitution of a dry powder, drug transfer from the vial to an IV bag, simulated drug administration, and IV push administrations through an IV port. With the conventional needle/syringe technique, each phase of the manipulations resulted in visible fluorescein leakage into the environment. Fluorescein leakage ranged in size from less than 1 to 50 mm in diameter. The syringes, work surfaces, gloves, manifold ports, and IV bag ports exhibited fluorescein contamination. With PhaSeal, no leakage was observed during any phase of the manipulations. Using the conventional needle/syringe technique during preparation of a hazardous drug may lead to release of the agent into the work environment, posing a health risk to the worker. A closed system such as PhaSeal has the ability to confine hazardous drugs, substantially reducing or possibly eliminating drug exposures.

scholarly journals Validation of chemotherapy drug vapor containment of an air cleaning closed-system drug transfer device

2021 ◽  
pp. 107815522110306
Author(s):  
Galit Levin ◽  
Paul JM Sessink
Keyword(s):  
Activated Carbon ◽  
Closed System ◽  
Membrane Filter ◽  
Drug Transfer ◽  
Glass Vessel ◽  
Air Cleaning ◽  
No Release ◽  
Activated Carbon Filter ◽  
Carbon Filter ◽  
Transfer Device

Purpose The purpose of this study was to test the efficacy of ChemfortTM, an air filtration closed-system drug transfer device to prevent release of chemotherapy drug vapors and aerosols under extreme conditions. The air cleaning system is based on the adsorption of drug vapors by an activated carbon filter in the Vial Adaptor before the air is released out of the drug vial. The functionality of the carbon filter was also tested at the end of device’s shelf life, and after a contact period with drug vapors for 7 days. Cyclophosphamide and 5-fluorouracil were the chemotherapy drugs tested. Methods The Vial Adaptor was attached to a drug vial and both were placed in a glass vessel. A needle was punctured through the vessel stopper and the Vial Adaptor septum to allow nitrogen gas to flow into the vial and to exit the vial via the air filter into the glass vessel which was connected to a cold trap. Potential contaminated surfaces in the trap system were wiped or rinsed to collect the escaped drug. Samples were analyzed using liquid chromatography tandem mass spectrometry. Results Cyclophosphamide and 5-fluorouracil were detected on most surfaces inside the trap system for all Vial Adaptors without an activated carbon filter. Contamination did not differ between the Vial Adaptors with and without membrane filter indicating no effect of the membrane filter. The results show no release of either drug for the Vial Adaptors with an activated carbon filter even after 3 years of simulated aging and 7 days of exposure to drug vapors. Conclusions Validation of air cleaning CSTDs is important to secure vapor and aerosol containment of chemotherapy and other hazardous drugs. The presented test method has proven to be appropriate for the validation of ChemfortTM Vial Adaptors. No release of cyclophosphamide and 5- fluorouracil was found even for Vial Adaptors after 3 years of simulated aging and 7 days of exposure to drug vapors.

Research on the V/H Inspection of Spiral Bevel Gear before Heat Treatment

2013 ◽  
Vol 483 ◽  
pp. 166-169
Author(s):  
Jia Lun Qiu ◽  
Rui Rong Zhao ◽  
Ying Jie Wang ◽  
Wei Zhao ◽  
Jing Cai Li
Keyword(s):  
Heat Treatment ◽  
Contact Region ◽  
Bevel Gear ◽  
Test Method ◽  
Spiral Bevel Gear ◽  
Basic Definition ◽  
Technical Process ◽  
Inspection Method ◽  
Spiral Bevel

The V / H inspection method is analyzed, including its basic definition, purpose and V / H inspection technical process of Gleason Company. In order to improve the quality of the contact region, Gleasons V / H test method is conducted for V/H inspection of spiral bevel gear before heat treatment, and analysis of experimental data is given.

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