Amichay Maya, Shimon Ortal, Raveh Eitan
Hy Laboratories Ltd., Rehovot, Israel.
Simplivia Healthcare Ltd., Kiryat Shmona, Israel.
Pharm Pract (Granada). 2021 Oct-Dec;19(4):2576. doi: 10.18549/PharmPract.2021.4.2576. Epub 2021 Nov 18.
Closed system drug-transfer devices (CSTD) allow the reconstitution of hazardous drugs into infusion bags, while preserving the sterility of the product and preventing the escape of liquids and aerosols into the environment. Air-cleaning technology CSTD is based on an activated carbon filter and a membrane which enable maintaining the drug sterile by filtration of air entering the vial during pressure equalization.
The study aimed to investigate if an air-cleaning CSTD can prevent liquid viral contamination by human coronavirus OC43 (HCoV-OC43).
Chemfort™ CSTD with (intact) or without (control) a Toxi-Guard system was used to transfer liquids between an IV bag and an empty vial (a total of 5 liquid transfers) inside a sealed glove box contaminated by HCoV-OC43 aerosols. In addition, the vial adaptor was challenged by direct spray of HCoV-OC43 solution on the septum and filter areas. HCoV-OC43 RNA was extracted from samples of the transferred liquid and compared between the devices with or without a Toxi-Guard system.
Use of a CSTD with the Toxi-Guard system resulted in non-detectable cycle threshold (CT) values, indicative of no detectable HCoV-OC43RNA in the transferred liquid, even when the septa and filter areas were directly sprayed with HCoV-OC43 stock solution. In contrast, use of the CSTD with no Toxi-Guard system resulted in a detectable CT value of the transferred liquid.
Using Chemfort CSTD with integral Toxi-Guard technology can prevent the introduction of microbial and airborne contaminants into the fluid path, thus potentially protecting patients from infection.
密闭式药物转移装置(CSTD)可将危险药物复溶至输液袋中,同时保持产品无菌,并防止液体和气溶胶泄漏到环境中。空气净化技术CSTD基于活性炭过滤器和隔膜,在压力平衡期间通过过滤进入小瓶的空气来保持药物无菌。
本研究旨在调查空气净化型CSTD是否能防止人冠状病毒OC43(HCoV-OC43)造成的液体病毒污染。
在被HCoV-OC43气溶胶污染的密封手套箱内,使用带有(完整)或不带有(对照)Toxi-Guard系统的Chemfort™ CSTD在静脉输液袋和空小瓶之间转移液体(共5次液体转移)。此外,通过将HCoV-OC43溶液直接喷洒在隔垫和过滤器区域来挑战小瓶适配器。从转移液体的样本中提取HCoV-OC43 RNA,并在有或没有Toxi-Guard系统的装置之间进行比较。
使用带有Toxi-Guard系统的CSTD导致循环阈值(CT)值不可检测,这表明即使隔垫和过滤器区域直接喷洒HCoV-OC43储备溶液,转移液体中也未检测到HCoV-OC43 RNA。相比之下,使用没有Toxi-Guard系统的CSTD导致转移液体的CT值可检测。
使用带有集成Toxi-Guard技术的Chemfort CSTD可防止微生物和空气传播污染物进入流体路径,从而有可能保护患者免受感染。