Best Practices in PDE/ADE and OEL Determinations
Health-based Exposure Limits (HBEL), also referred to as Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE) values, are used to calculate Maximum Allowable Carryover (MAC/MACO) or Maximum Safe Carryover (MSC) limits in pharmaceutical cleaning validation. Similarly, Occupational Exposure Limit (OEL) values help ensure that the airborne concentration of pharmaceuticals is within acceptable limits so that workers are safe in manufacturing settings.