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The specific exposure control objectives to maintain at all times point-source air concentrations of active ingredients at or below specific measurements through the use of engineering controls, and to prevent migration of particulate out of the process rooms through the use of process and facility engineering controls, and good work practices. OELs are usually established late in clinical development and they are based on Time Weighed Average (TWA), average employee exposure of his/her breathing zone (the air around nose and mouth) to concentration of compounds for 8 hours, 40 hours per week. They may include a Short-Term Exposure Limit (STEL) for compounds with acute effects, and they are normally supported with an industrial hygiene sampling method.
An OEL is a health-based airborne concentration limit to which worker exposure levels should be controlled. Limits are usually expressed as eight-hour time weighted averages for exposures for 40 hours a week over a working lifetime.
Publication Source: ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition)
Publication Date: 2012
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