Tag Archive | "residue limits"

Risk Based Limits and Pharmaceutical Cleaning

Q. We are moving from LD50 data to ADE (PDE) limits based on HBELs. This is allowing us to eliminate disposables for low-risk products.  How do I know which can be manually cleaned and which needs to be in a washer? Can manual cleaning be validated?

A. Many pharma and biotech companies have been moving to Health-Based Exposure Limits (HBELs) meaning Acceptable Daily Exposure (ADE) or Permitted Daily Exposure (PDE) limits as detergent residue limits.    

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