Acceptable Daily Exposure Limits

Acceptable Daily Exposures in the US, or Permissible Daily Exposures in the UK, are levels at which a compound can exist as a contaminant in another pharmaceutical with a low risk of causing an adverse health effect in patients. 

The intent is to manage risk by limiting cross-contamination and residual levels in manufacturing environments in which multiple pharmaceuticals are produced using the same equipment. 

These reports establish cleaning limits for active pharmaceutical ingredients and other potentially hazardous substances.

This health-based risk assessment is often requested by Contract Manufacturing Organizations (CMOs) or Contract Research Organizations (CROs) in conjunction with an OEL. It is most appropriate for pharmaceuticals that have completed non-clinical testing and Phase II clinical trials or later.