Source Apportionment and Quantification of Liquid and Headspace Leaks from Closed System Transfer Devices via Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) (Dataset)

Details

• Corporate Authors:
  National Institute for Occupational Safety and Health
• Description:
  Closed system drug-transfer devices (CSTDs) are devices which replace traditional needles, septa, and other connectors used for transferring hazardous drugs (HDs). NIOSH recommends using CSTDs to limit occupational exposure to hazardous materials and sharps when compounding and administering these drugs (NIOSH 2004). One of the engineering challenges associated with CSTDs is management of the headspace that is either compressed or displaced when transferring liquids in and out of drug vials. CSTD designs and components employing various technologies include creating a physical barrier to contain the displaced volume of air or filters to clean the displaced volume of air when transferring HD solutions. In 2015, NIOSH developed a protocol to test material containment of barrier type CSTDs (NIOSH 2015). NIOSH presented a plan to update the testing protocol so that it was applicable to both barrier and air cleaning types of CSTDs (NIOSH 2016). Both barrier type CSTDs and air cleaning type CSTDs may be susceptible to either liquid or headspace vapor leaks. Air-cleaning type CSTDs allow free passage of air but are expected to remove semi-volatile hazardous drugs (HD)s from the exiting airstream. Barrier type CSTDs have been designed to contain air rather than clean it, and it is reasonable to conclude that a headspace leak with a barrier type CSTD would contain the drug at the same concentration as the headspace inside the vial. As a result, the procedure described in this paper can adequately assess the efficacy of barrier type CSTDs based on the volume of liquid and headspace vapor leak measured. However, the volatile compounds used in this procedure will readily pass through an air-cleaning CSTD, regardless of the ability to retain a semi-volatile HD. Therefore, testing the efficacy of an air-cleaning CSTD requires coupling the procedure described herein with an assessment of the ability of air cleaning CSTDs to retain an appropriate semi-volatile surrogate when volumes of headspace containing that surrogate are passed through the CSTDs. The difference in the amount of HD contained in liquid versus headspace vapor leaks may be several orders of magnitude. The work presented herein is a test method that can distinguish the origin and volumetric quantity of liquid and headspace vapor leaked. [Description provided by NIOSH]
• Subjects:
  Drug Therapy Hazardous Substances Occupational Health Safety Solvents
• Keywords:
  Drug Therapy Hazardous Drugs Leak Detectors Mass Spectrometry Medical Treatment Medicinal Chemicals Vapors
• DOI:
  https://doi.org/10.26616/NIOSHRD-1023-2021-0
• Publisher:
  National Institute for Occupational Safety and Health
• Document Type:
  Dataset
• Genre:
  Research Dataset
• Place as Subject:
  Ohio ; OSHA Region 5
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Division:
  HELD - Health Effects Laboratory Division
• Topic:
  Workplace Safety & Health
• Location:
  North America
• NIOSHTIC Number:
  nn:20063617
• Citation:
  Cincinnati, OH: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, Research Dataset RD-1023-2021-0, 2021 Oct; :dataset
• Contact Point Address:
  Chemical and Biochemical Monitoring Branch (CBMB), Health Effects Laboratory Division (HELD), National Institute for Occupational Safety and Health (NIOSH), Cincinnati, OH, 513.841.4414
• Federal Fiscal Year:
  2022
• Peer Reviewed:
  False
• Source Full Name:
  Source apportionment and quantification of liquid and headspace leaks from closed system transfer devices via Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) (dataset)
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:0a406ed666542d15b8946b62fb7303295997d1586deec2509d5395e71f5df9f28c4b94d158c904e0c5527066bef4cb8820a0abe5da78a45b146e573f2c2e8579
• Download URL:
  https://stacks.cdc.gov/view/cdc/222190/cdc_222190_DS1.pdf
• File Type:
  [PDF - 112.94 KB ]