Health Based Exposure Limits (HBEL)
and Cleaning Validation services
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.
How RABT Toxicologists Can Help
🧪
PDE / ADE Determination
🧼
Cleaning Validation (CV)
🏭
Occupational Exposure Limit (OEL)
📋
Health Based Exposure Limits
Our Expertise Includes
📘 Regulatory & Scientific Excellence
- PDE calculations in compliance with EMA/CHMP/CVMP/SWP/169430/2012
- PDE reports approved by board-certified (DABT / ERT) toxicologists
- Scientific identification of POD, NOAEL, NOEL, LOAEL
🧬 Comprehensive Toxicological Review
- Hazard alerts and summary
- Acute toxicity (LD50), skin/eye irritation, sensitization
- Repeat dose toxicity
- Reproduction & developmental toxicity
- Genotoxicity & carcinogenicity
- Clinical evidence including sensitive populations
⚗️ Advanced Risk Approaches
- TTC approach for genotoxic substances (ICH-M3 R2)
- PDE/ADE for alternative routes of exposure
- PDE levels for solvents and impurities
🏛️ Regulatory & GMP Support
- GMP audit support (pre / post inspection)
- Answering agency queries
- Technical and protocol support during cleaning validation
Our Commitment
We are committed to ensuring the safety and efficacy of your medicinal products through our expertise in
PDE, ADE, HBEL, and cleaning validation.
