An assessment of seven closed system transfer devices in accordance with the 2015 NIOSH vapor containment performance protocol
Bibliographic record
Abstract
Introduction The purpose of this study was to assess and compare the effectiveness of seven different closed system transfer device (CSTD) product lines following the 2015 NIOSH Vapor Containment Performance Protocol, using a Gasmet™ DX5000 Terra multigas FTIR analyzer. Methods Seven different CSTD systems were assessed using a two-task evaluation on their capacity to contain the NIOSH-specified challenge agent, 70% isopropyl alcohol (IPA). Task 1 simulated reconstitution and compounding steps while Task 2 simulated compounding and administration steps. Vial adapters, syringe adapters, IV bag adapters, and y-site adapters from each CSTD product line were tested. All tasks were performed in a custom-built environmental test chamber as outlined in the 2015 NIOSH protocol, with isopropyl alcohol (IPA) release detected and measured by a Gasmet™ analyzer. Results The BD PhaSeal™ CSTD product line effectively contained IPA vapor during both tasks with a task performance metric of 0.00 ppm for each task. BD PhaSeal™ Optima, Equashield ® , Yukon Medical Arisure ® , ICU Medical ChemoLock™, BD Texium™, and ICU Medical ChemoClave™ non-vented CSTDs demonstrated detectable and quantifiable IPA leakage during each task. The leaks occurred at different steps within the protocol, and the amount of IPA vapor detected varied. Conclusion In this study, one CSTD product line (i.e., PhaSeal™) successfully contained IPA vapor below the Gasmet™ analyzer's limit of quantification (LOQ) for IPA of 0.04 ppm for both Tasks 1 and 2, demonstrating it to be a validated closed system per the study protocol. All other CSTD product lines demonstrated some level of IPA leakage with task performance metrics above the analyzer's LOQ. However, these results tell us little about how well CSTDs contain hazardous drugs (HDs), as a universal HD surrogate for effectively assessing the closedness of all types of CSTDs has yet to be identified.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.002 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".