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5PSQ-013 New method for assessment of environmental viral contamination of liquids prepared in closed-system drug transfer devices
  1. E Slutsky Smith1,
  2. M Amichay2
  1. 1Simplivia Healthcare- Ltd., Design and Development, Kiryat Shmona, Israel
  2. 2HY Laboratories- Ltd., Virology and Tissue Culture Unit, Rehovot, Israel


Background and Importance Closed system transfer devices (CSTDs) enable sterile preparation and administration of drugs.

Drugs contaminated by microbes harbour clinical risk to patients. Drugs suspected of contamination must be disposed of, adding economic burden to pharmacies. CSTDs can prevent contamination by bacteria and fungi.1 However, a method for testing CSTDs’ ability to prevent viral contamination is needed.

Aim and Objectives The aim was to develop a method for evaluating CSTDs’ ability to prevent viral contamination, including two case studies with CSTDs, only one of which has been published.2

Material and Methods Case studies were performed with Chemfort® and PhaSeal™ Optima CSTDs inside a glove box continuously aerosolised with human coronavirus HCoV-OC43. With Chemfort®, reconstitution was simulated by transferring sterile saline from IV bag to vial and back to IV bag. With Optima™, bolus preparation was simulated by transferring sterile saline from vial to syringe, and infusion preparation was simulated by transferring sterile saline into an IV bag. Three repetitions times three technical replicates were performed for each simulation. HCoV-OC43 RNA in syringes and IV bags was quantified by qPCR, including calibration samples. Air sampling verified the continued presence of viral aerosols in the glove box. For negative control, liquid transfers were performed in the presence of sterile medium aerosols.

Results Viral RNA could be quantified at concentrations ≥ 5 PFU/ml.

Chemfort®: No viral RNA traces were detected in any of the nine replicates Optima™: In bolus simulations, viral RNA traces were observed in all nine replicates and were within the quantifiable range for 56% of replicates. In infusion simulations, viral RNA traces were observed in 67% of replicates, but were below the quantifiable range.

Conclusion and Relevance A method was developed for testing CSTDs’ ability to prevent viral contamination. The method was applied to two CSTDs for different simulated pharmacy tasks. The method can be applied for evaluation of additional CSTDs and for direct comparison between CSTD brands performing the same tasks. The knowledge gained could help protect vulnerable patients from viral infection.

References and/or Acknowledgements 1. Mills A, Yousef M. Drugs & Therapy Perspectives. 2021;37:206–11.

2. Amichay M, Shimon O, Raveh E. Pharm Pract. 2021;19(4):2576.

Funding provided by Simplivia Healthcare Ltd.

Conflict of Interest Corporate sponsored research or other substantive relationships:

Maya Amichay declares no conflict of interest. relating to the material presented in the abstract. Elana Slutsky Smith is employed by Simplivia Healthcare Ltd, the manufacturer of Chemfort®.

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