This CPCI™ HBEL calculator was developed by CPCI™ from the ASTM E3219 Standard Guide for Derivation of Health Based Exposure Limits (HBELs) to be used by Qualified Experts. The purpose of this HBEL calculator to provide an easy-to-use tool to help companies implement the guidance found in E3219. Using the tool allows the user to follow the ASTM E3219 when calculating an HBEL. The calculator allows you to enter the necessary information and then generates the report table that is shown in ASTM E3219 which can then be added to the HBEL Monograph.

This calculator is most appropriate and is targeted specifically for OTC drugs, generic drugs and older drugs where the toxicological and clinical information necessary for the derivation of the HBEL are readily available from public sources. The calculator can also be used by innovator companies who have access to internal information.

The calculator has been “peer reviewed” privately by a small group of select toxicologists with positive feedback. The CPCI™ HBEL calculator is a FREE online software tool for members of Center for Pharmaceutical Cleaning Innovation (CPCI).