Determination of a PDE in compliance with EMA/CHMP/CVMP/SWP/169430/2012 guidelines:

• Hazard identification by reviewing all relevant data

• Identification of “critical effects”

• Determination of the no-observed-adverse-effect level (NOAEL)

• Use of appropriate adjustment factors

Calculation of Occupational Exposure Limits (OEL) to minimize worker exposure to hazardous substances

Compliance with regulatory guidelines and frameworks such as EMA, OSHA, ACGIH, NIOSH, and ECHA

Determine the maximum acceptable carryover (MACO) values - Cleaning validation