CPCI™HBEL Monographs

CPCI™ is actively developing a Database of Health Based Exposure Limit (HBEL) Monographs from the World Health Organization's (WHO) Essential Medicines List for use in cleaning validation which we intend to offer to CPCI™ Members at very affordable prices.

All CPCI™ HBEL Monographs are:

• Derived following the ASTM International E3219 "Standard Guide for Derivation of Health Based Exposure Limit (HBEL)". 
  
• Derived by "Qualified Experts" (as per ASTM E3219).
• Quality Review and approval by CPCI™.
• Contain all pertinent Cleaning Validation information (Solubility, Carbon content, Maximum Daily Dose, etc.)
• Contain a "PDE Determination Strategy" as per the EMA "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities".
  

Need an HBEL Monograph or have a question?