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The Transition to Risk-Based and Health-Based Exposure Limits in Pharmaceutical Cleaning Validation
Description: Highlighting the industry's shift from arbitrary or concentration-based cleaning limits to modern, scientifically sound, patient-centric criteria like Health-Based Exposure Limits (HBELs).
A major paradigm shift has taken place in the Pharmaceutical Cleaning Validation Market with the move from prescriptive, worst-case-product approaches to a risk-based, scientific framework. This transition is championed by regulatory bodies, including the European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which now mandate the use of Health-Based Exposure Limits (HBELs).
HBELs, such as the Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE), establish the maximum acceptable daily intake of a substance that is unlikely to cause an adverse effect if an individual is exposed to it every day for a lifetime. Applying HBELs ensures that cleaning limits are based on the toxicology and pharmacological properties of the compound rather than arbitrary or fixed criteria like the 10 ppm rule or the 0.001 of the minimum therapeutic dose.
This science- and risk-based approach is crucial, especially in multi-product facilities where the risk of cross-contamination is higher. It allows manufacturers to logically prioritize and justify the cleaning validation efforts for the highest-risk products and equipment, leading to more efficient resource allocation and better overall quality risk management in line with ICH Q9 guidelines. This modern standard represents a significant step forward in ensuring patient safety is the primary consideration for cleaning procedures.