5PSQ-023 Litmus test method for closed system transfer device dry disconnection validation

<h3>Background and Importance</h3> Membrane-based closed system transfer devices (CSTDs) aim to prevent liquid release of hazardous drugs (HDs) upon connection and disconnection of adapters using self-sealing membranes. Different methods have been used to validate this dry disconnection, including visual evaluation and GC/MS detection following liquid evaporation. Litmus testing with alkaline drug 5-fluorouracil has been used to validate a vial and syringe adapter from one manufacturer. <h3>Aim and Objectives</h3> The aim was to validate dry disconnection of vial, syringe, and bag adapters from an additional CSTD manufacturer using a litmus-based method, with a more challenging solution than 5-fluorouracil. <h3>Material and Methods</h3> 5-Fluoruracil, a HD with pH 9.2, is expected to turn litmus red paper blue upon contact. However, the visual response is clearer at pH 11. Thus, a solution of sodium hydroxide at pH 11 was prepared as a worse-case representative of 5-fluorouracil. Five transfers (10 connections for the syringe adapter) of this solution were performed from vial, via syringe, to IV bag, using a membrane-based CSTD, according to its instructions for use. Following each disconnection, the device septa were sampled with a moist litmus red paper, and colour change was evaluated. This was repeated for 10 sets of adapters. Distilled water replaced the basic solution in a negative control. Positive controls were performed by applying drops of basic solution on the litmus paper or on the septa prior to sampling. <h3>Results</h3> No blue colour change was observed on the litmus paper used for sampling test devices following disconnections, nor in the negative control. Blue colour change was observed in all positive controls. <h3>Conclusion and Relevance</h3> No liquid release was detected on septa of the tested CSTD during five transfers using 10 sets of devices. The solution used is an even stronger base than the 5-fluorouracil used in other studies. Thus, the litmus paper is expected to be even more sensitive to releases of this solution. The study verifies the dry disconnection of the device tested, strengthening the case for CSTDs as an important layer of protection against HD exposure. The method is inexpensive, requires no special equipment, and can readily be applied to additional CSTDs for comparison. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> Corporate sponsored research or other substantive relationships The author is employed by Simplivia Healthcare, Ltd., a CSTD manufacturer.