Toxi risk assessment
Health Based exposure limit is a safe threshold level for an active substances obtained scientifically. Manufacturing of active pharmaceutical ingredients (APIs) and products in pharmaceutical industry requires qualitative and/or quantitative health based risk assessment for occupational exposure level (OEL is required for workers safety and control banding for facility type selection in plants) and Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE) (for patient safety, prevention of cross contamination and cleaning validation.
To evaluate the safety concern for a substance and to estimate a safe exposure level for drug impurities, solvents, metals, excipients, coloring agent (if exceeds IIG level or any safety concerns).
F-value assessments to determine unit packaging for pharmaceuticals, dietary supplements, etc. Pursuant to the POISON PREVENTION PACKAGING ACT OF 1970, as enforced through the CONSUMER PRODUCT SAFETY COMMISSION, we review toxicology and safety data in addition to clinical data for your product to determine the “F-Value”, or the maximum number of units of the product to comply with Child-Resistant Testing Requirements for unit dose packaging. The F-Value refers to the number of individual units to which access is considered a test failure is commonly, and unofficially, referred to as “F”. This value takes into consideration the individual units of a product that can be removed from a package. For example: If the toxicity of a substance requires access to 2 units to be considered a test failure, the substance is said to require an F=2 package.
