Health Based Exposure Limits (HBEL)
and Cleaning Validation services

We help pharmaceutical manufacturers comply with EMA guidelines by establishing scientifically sound
Permitted Daily Exposure (PDE) / Acceptable Daily Exposure (ADE) values and supporting complete cleaning validation programs.

The pharmaceutical industry is responsible for producing various medicinal products in shared facilities, and it is obligated to adhere to the guidelines set by the European Medicines Agency (EMA) regarding Health Based Exposure Limits (HBEL) to avoid any toxicological risk.

The PDE is a substance-specific dose that is unlikely to cause harm if an individual is exposed to it daily for a lifetime. Establishing Permitted Daily Exposure (also known as Acceptable Daily Exposure – ADE) is an essential part of the cleaning validation program.