“ A drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of the hazardous drug or vapor concentrations outside the system ” . 1.Physical Barrier - Blocking the unintended release of drug into the surrounding environment or the intake of environment contaminates into a sterile drug pathway. 2.Air Cleaning - Prevents the unintended release of drug into the surrounding environment or the intake of environmental contaminates into the sterile drug pathway. The NIOSH definition is the only definition that includes drug vapors.DHHS (NIOSH) Publication Number 2004–165, September 2004. NIOSH considers the containment of vapor extremely important, such that in September 2015, NIOSH issued a Testing Protocol to assess the effectiveness of closed systems. NIOSH developed and tested 5 CSTDs to assess its "closeness . " 2 of the 5 CSTDs tested passed. Test Protocol for Closed System Transfer Devices by NIOSH NIOSH (The National Institute for Occupational Safety and Health, US), recognized the importance of having a universal protocol for evaluating the performance of CSTDs ( Closed System Transfer Devices ). Chemfort, Tevadaptor, PhaSeal and Equashield reduced the quantity of contamination between 5-60 fold. Relative to the needle and syringe, and results were below limitof quantitation. The test results for the needle and syringe show the potential risk of drug release and contamination when a CSTD is not used for drug compounding the transfer. Chemoclave results are similar to those of needle and syringe, showing a significant level of contamination. Solutions Commercially available CSTD products include the following: PhaSeal (BD, USA ) Arisure (Yukon Medical, USA ) Tevadaptor (Simplivia Healthcare, Israel) Chemfort (Simplivia Healthcare, Israel) Halo (Corvida, USA ) ChemoClave (ICU Medical, USA ) ChemoLock (ICU Medical, USA ) Equashield II (Equashield, USA) NeoShield ® (JMS, Japan & USA )
" A drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of the hazardous drug or vapor concentrations outside the system " . Physical barrier - Blocking the unintended release of drug into the surrounding environment or the intake of environment contaminates into a sterile drug pathway. Air cleaning - Prevents the unintended release of drug into the surrounding environment or the intake of environmental contaminates into the sterile drug pathway. The NIOSH definition is the only definition that includes drug vapors.DHHS (NIOSH) Publication Number 2004–165, September 2004. NIOSH considers the containment of vapor extremely important, such that in September 2015, NIOSH issued a Testing Protocol to assess the effectiveness of closed systems. NIOSH developed and tested five CSTDs to assess its "closeness " . Two of the five CSTDs tested passed. Test protocol for closed system transfer devices by NIOSH NIOSH (The National Institute for Occupational Safety and Health, US), recognized the importance of having a universal protocol for evaluating the performance of CSTDs ( closed system transfer devices ). Chemfort, Tevadaptor, PhaSeal and Equashield reduced the quantity of contamination between 5-60 fold. Relative to the needle and syringe, and results were below limit of quantitation. The test results for the needle and syringe show the potential risk of drug release and contamination when a CSTD is not used for drug compounding the transfer. Chemoclave results are similar to those of needle and syringe, showing a significant level of contamination. Products Commercially available CSTD products include the following: PhaSeal (BD, US ) Arisure (Yukon Medical, US ) Tevadaptor (Simplivia Healthcare, Israel) Chemfort (Simplivia Healthcare, Israel) Halo (Corvida, US ) ChemoClave (ICU Medical, US ) ChemoLock (ICU Medical, US ) Equashield II (Equashield, US) NeoShield (JMS, Japan & US )
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1.Physical Barrier
Physical barrier
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2.Air Cleaning
Air cleaning
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5
five
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2 of the 5
. Two of the five
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Protocol for Closed System Transfer Devices
protocol for closed system transfer devices
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Closed System Transfer Devices
closed system transfer devices
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limitof quantitation.
limit of quantitation.
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Solutions
Products
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USA
US
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USA
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USA
US
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USA
US
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USA
US
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USA) NeoShield ®
US) NeoShield
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USA
US