Head-to-head containment performance testing of four commercially available closed-system transfer devices using the 2016 Draft NIOSH test protocol and 2.5% w/v 2-phenoxyethanol as challenge agent
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Objectives
The 2016 Draft National Institute for Occupational Safety and Health (NIOSH) universal protocol “A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs.” employing ATD-GC-MS with the 2016 Draft NIOSH proposed challenge agent 2-Phenoxyethanol (2-POE, 2.5% w/v in water) was used to assess the containment performance of two barrier and two air-cleaning CSTDs in a head-to-head test with replication (n=4) for both NIOSH tasks 1 (drug preparation) and 2 (drug administration). The study objective was to assess the containment performance of both physical barrier and air-cleaning CSTDs.
Methods
ChemoLock™ barrier (ICU Medical, USA), ChemoLock™ air-cleaning (ICU Medical, USA), PhaSeal™ barrier (Becton Dickinson, USA), and Tevadaptor™ air-cleaning (Simplivia, IL – now marketed as Chemfort™) CSTDs were evaluated using the 2016 Draft NIOSH universal test protocol for Task 1 (n=4) and Task2 (n=4). A 100 mL empty IV bag, accessed with a CH-10 ChemoClave™ bag spike was used with the IV administration set in Task 2 to avoid pressurisation of the occluded administration set during the simulated “IV push”. Air samples were collected (GilAir pump) at 100mL/minute for 30 minutes on Tenax TA thermal desorption (TD) tubes (Markes, UK). 2-POE, a semi-volatile surrogate mimicking hazardous drugs was prepared at 2.5% w/v solution in MilliQ water. This was aliquoted (50mL) into drug vials and crimp sealed with a butyl rubber stopper (Adelphi, UK). 2-POE was analysed against a calibration curve (n=8) in the range 0.6ng to 200ng using analytical methods published previously. Chromeleon v7.3 CDS (Thermo Scientific, UK) was used for analysis based on detection of SIM ions (M/Z: 77, 94, 138). Blank TD tubes (n=85) were used to determine the experimental LOD and LLOQ. Negative control tests (employing MilliQ water as surrogate) were performed for each CSTD Task 1 (n=1) and Task 2 (n=1). An open “needle and syringe” positive control test was performed at 5 and 10 microlitre volumes in the NIOSH chamber to demonstrate system suitability.
Results
Chamber cleaning and analysis performed between tests, gave average blank values (n=85) of 0.05±0.01 ppbv (95% confidence interval). The experimental limit of detection (LOD) and quantification (LLOQ) for the tests was 0.16±0.01 ppbv and 0.41±0.01 ppbv respectively. The positive control tests produced signals of 3.13 ppbv (n=1) and 6.59 ppbv (n=1) for 5 microlitre and 10 microlitre releases of 2-POE respectively and demonstrated system suitability to quantify down to a 650 nanolitre liquid release volume. (1) ChemoLock™ barrier, (2) ChemoLock™ air-cleaning, (3) BD PhaSeal™ barrier and (4) Tevadaptor™ air-cleaning CSTDs all generated <LLOQ signals for both NIOSH tasks 1 and 2. No statistically significant difference was found between the containment performance of the two air-cleaning and the two physical barrier CSTDs evaluated in this study.
Conclusions
System suitability was demonstrated using deliberate releases of the 2-POE surrogate at 5 and 10 microlitre volumes producing 2-POE concentrations in the NIOSH chamber of 3.13 ppbv and 6.59 ppbv respectively. Evaluation of the containment performance gave <LLOQ (0.41±0.01ppbv) for all four of the CSTDs tested in the study: (1) ChemoLock™ barrier, (2) ChemoLock™ air-cleaning, (3) BD PhaSeal™ barrier and (4) Tevadaptor™ air-cleaning, based on testing of four replicates of each technology in both NIOSH Task 1 and NIOSH Task 2. There was no statistically significant difference in containment found between the two air-cleaning and the two barrier CSTDs evaluated in this study.
