OEL and PDE values for pharmaceuticals

The purpose of deriving OEL and PDE values is to protect workers and patients from occupational exposure and cross-contamination, respectively. It is a regulatory requirement for active pharmaceutical ingredients (APIs).

The occupational exposure limit (OEL) value is derived to protect workers from inhalational exposure during work with the API. In REACH terminology the OEL is known as DNELinhalation for workers. The OEL value is derived in accordance with the guidelines from the European Chemicals Agency (ECHA) on OEL values/DNELinhalation for workers. The value is expressed in mg API/m3.

The permitted daily exposure (PDE) value, on the other hand, is expressed in mg API/day and is meant to protect patients in case of cross-contamination of other pharmaceuticals with the API. The PDE value is derived according to guidelines from the European Medicines Agency. Typically, the PDE value is derived for parenteral administration routes, such as intramuscular or intravenous injection, or for oral administration.

For further information on deriving OEL and PDE values, please contact:

Poul Bo Larsen 
Tel +45 4516 9478