Introduction to Risk Assessment

Toxicological risk assessments are prepared to provide a thorough review of the chemicals in your extractables/leachables report. Following ISO 10993 - 17, our toxicologists assess each chemical to establish a margin of safety and determine whether the further testing or analysis is required to reduce the risk.

Left image Toxicological risk assessment
Left image Biological evaluation
Left image R&D Design Discussion
Left image Problem solving
Left image Other
Permitted Daily Exposure(PDE)Evaluation

It represents a substance-specific dose that is unlikely to cause an adverse effect if an individual is exposed at or below this dose every day for a lifetime.

Following the relevant guidelines, experienced toxicologists will use high-quality data and identify the sensitive toxicity endpoint (such as NOAEL, LOAEL, etc.) based on existing information, registered materials or other officially released safety limits, and apply the appropriate uncertainty factor (UF1-UFn) to evaluate the PDE. When necessary, use computer toxicity prediction software (QSAR method) to predict the toxicity.

Relevant guidelines
  • ICH Q3C. Impurity: guideline for residual solvents Q3C(R7). 2018
  • ICH Q3D. Guideline for elemental impurities Q3D (R1). 2019
  • ISO 10993-17. Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances. 2002
  • EMA/CHMP/ CVMP/ SWP/169430/2012. Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
  • Published literatures for “Setting Occupational Exposure Limits (OELs) for Pharmaceuticals”
Our advantages
  • Global certified experienced toxicologist team
  • More than 70,000 items of toxicological assessment data for chemical substances
  • Standard reporting templates for global submissions
  • Internationally recognized toxicity prediction software(QSAR)
Business Scope
  • Safety Assessment of Pharmaceutical Packaging
  • Residue Limits Setting in Pharmaceutical Manufacturing Environments

To learn more about medical machinery testing, please contact us