ISPE Glossary of Pharmaceutical and Biotechnology Terminology

Print this page         
Find Definition by Term and/or Language
Term Language (Optional)
Browse All Terms
Beginning With By Language
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z :: All English
Deutsch
Francais

Occupational Exposure Limits (OEL)

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.

See also: Performance-Based Occupational Exposure Limits (PB-OEL)

Occupational Exposure Limits (OEL)

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

Do you have a term that should be included in the glossary?
Submit a term for review

My ISPE

  • Click to go to My Communities of Practice
  • Click to go to My Affiliate or Chapter
  • Click to go to My Profile
Click to go to the Member Gift