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adicionou um novo artigo Health

2026-01-13 08:59:38 -

Cleaning Validation 2026: Is "Risk-Based HBEL" the End of the 10ppm Rule?

The year 2026 marks the final departure from the "One-Size-Fits-All" 10ppm (parts per million) cleaning limit, replaced by Health-Based Exposure Limits (HBEL). In 2026, cleaning validation is strictly governed by toxicological data, such as Permitted Daily Exposure (PDE), tailored to the specific toxicity of the drug being made. This 2026 "Scientific Rigor" means that for highly toxic oncology...

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