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3PC-007 Containment performance assessment of Chemfort® (Onguard®2) closed system transfer device according to 2016 draft NIOSH protocol at first and tenth activations end of shelf life
  1. A Wilkinson,
  2. L Ozolina,
  3. K Walker,
  4. M Allwood,
  5. A Wallace,
  6. R Bon
  1. Biopharma Stability Testing Laboratory Ltd, RandD, Nottingham, UK


Background and Importance The National Institute of Occupational Safety and Health (NIOSH) defines a CSTD as a device that mechanically prohibits the transfer of environmental contaminants into and escape of hazardous drug or vapour outside of the system. After several connection/disconnection cycles (activations) and extended storage the containment performance of a CSTD may deteriorate risking exposure. The Chemfort® CSTD is approved for 10 activations.

In 2016, NIOSH issued a draft performance test protocol for CSTDs. The protocol recommends nine potential surrogates for hazardous drugs including 2-phenoxyethanol which was recommended by the UK Health and Safety Executive.

Aim and Objectives The study aim was to evaluate the containment performance of Chemfort® at first and tenth activations and the end of its 3-year shelf-life in accordance with the 2016 draft NIOSH protocol and instructions for use.

Material and Methods NIOSH Tasks 1 (reconstitution) and 2 (administration) were performed using 3-year aged Chemfort® following the 2016 NIOSH protocol, using 2.5% v/v 2-phenoxyethanol as surrogate. Devices were assessed in replicate (n=4), on first and tenth activation. Surrogate release was quantified using a qualified thermal desorption-GC/MS method. Positive control tasks were performed with needle and syringe. Limits of detection (LOD) and quantitation (LOQ) were determined based on chamber blank measurement.

Results The LOD and LOQ for 2-phenoxyethanol were determined at 0.36±0.013 ppb and 0.62±0.013 ppb (n=33) respectively. Mean surrogate releases for Chemfort® from both tasks were below the LOD at end of shelf-life at both one and ten activations. Positive controls gave mean releases of 7.79 ppb and 1.82 ppb for tasks 1 and 2, respectively.

Conclusion and Relevance No difference in containment performance was observed for Chemfort® components used at first vs tenth activation at end of shelf-life according to 2016 draft NIOSH protocol. All devices demonstrated containment of 2-phenoxyethanol surrogate. Positive controls demonstrated >LOQ releases of 7.79 ppb and 1.82 ppb for tasks 1 and 2, respectively for an open system. This is the first time CSTD performance has been evaluated at end of shelf-life and tenth activation.

References and/or Acknowledgements 1. Wilkinson AS, et al. PloSOne 2018;13(10):p.e0205263.

2. NIOSH. A performance test protocol for closed system transfer devices used during pharmacy compounding and administration of hazardous drugs. CDC-2016–0090-0002.

Conflict of Interest Conflict of interest.

Corporate sponsored research or other substantive relationships:

The research study described was the subject of a research grant provided by Simplivia Healthcare (IL) who also kindly provided the Chemfort® CSTD devices for testing.

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