Quality Assurance for Human Exposure Studies

    Published: Jan 1985

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    Data derived from exposure of human subjects to air pollutants are a basis for setting air quality standards. It is therefore imperative that those data be valid and defensible.

    Since 1979, Northrop Services, Inc.-Environmental Sciences, under contract to the U.S. Environmental Protection Agency, has been responsible for the development and implementation of a comprehensive program of quality assurance for human exposure studies. Exposure studies are conducted in controlled environment laboratories located in Chapel Hill, North Carolina.

    The planning and design of the quality assurance (QA) program are discussed. Details of the conduct and scheduling of systems and performance auditing, as well as hardware and software needs, are provided. A historical review of auditing results is presented, and unique problems are described for pollutant generation, delivery, and control systems as well as environmental control and physiological data acquisition.


    aerosol, aerosol subsystem, audit, calibrated transducer, calibration flow-rate, cascade impactor, clean room, Clinical Environmental Laboratory, corrective action, distribution audit, end-to-end audit, environmental subsystem, exposure chamber, gaseous pollutant, human exposure testing, performance audit, physiological data acquisition, physiological data acquisition subsystem, quality assurance, safety audit, single filter sampler, systems audit

    Author Information:

    Hackworth, LT
    Northrop Services, Inc.-Environmental Sciences, Research Triangle Park, NC

    Jordan, RC
    Northrop Services, Inc.-Environmental Sciences, Research Triangle Park, NC

    Smith, DH
    Northrop Services, Inc.-Environmental Sciences, Research Triangle Park, NC

    Howard, JN
    U.S. Environmental Protection Agency, Inhalation Toxicology Division, Clinical Research Branch, Chapel Hill, NC

    Committee/Subcommittee: D22.01

    DOI: 10.1520/STP30309S

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