Table III

Risk Factors Used in the Risk Evaluation Matrix

Contributing Factors Related to the Contact (Additive)
Risk Factor I (RFI)Kinetic Factor
    Aspect IATemperature of Contact
    Aspect IBDuration of Contact
    Aspect ICDimensional Factora
Risk Factor II (RFII)Thermodynamic Factor; “Leaching Power” of Contact Solution
    Aspect IIAEffect of pH
    Aspect IIBEffect of Polarity
Risk Factor III (RFIII)Material Factors
    Aspect IIIATotal Pool of Additives as Potential Extractables
    Aspect IIIBRelative Diffusion Rates
    Aspect IIICMaterial Processing Effects
    Aspect IIIDAlerts
Mitigating Factors, Post-Contact (Multiplicative)
Risk Factor IV (RFIV)Process Factor; Proximity of the Contact to the Final Process Step
    Aspect IVAConcentrating Steps between Contact and Final Product
    Aspect IVBDiluting Steps between Contact and Final Product
    Aspect IVCClearance Steps between Contact and Final Product
Risk Factor V (RFV)Final Product Factors
    Aspect VARisk Categorization: Likelihood of Interaction and Route of Administration
    Aspect VBDuration of Clinical Exposure
    Aspect VCDaily Dose Volume

  • ↵a Note: a As discussed in the text, the risk score for Risk Factor I does not include a consideration of dimensional factors.