Based on the results of the evaluation of the packaging and manufacturing materials, Socosur suggests a toxicological evaluation and risk assessment.
The methodology applied by Tox by Design toxicological experts consists of:
Degree of concern associated with the route of administration | Probability of product-material interaction | ||
High | Low | ||
High | Inhaled aerosols and solutions; injections and injectable solutions | Powders and sterile powders for inhalation and injection | |
Medium | Ophthalmic solutions and suspensions; transdermal patches; nasal aerosols and sprays | ||
Low | Topical solutions and suspensions; topical and lingual aerosols; oral solutions and suspensions | Topical and oral powders | Oral gelatine tablets and capsules |
EVALUATION OF PACKAGING AND MANUFACTURING MATERIALS
- Specifications of each material
- Conditions of use and storage
TOXICOLOGICAL EVALUATION OF EXTRACTABLE
For a extractable substance identified in the analytical part, we perform a toxicological review based
- Bibliographic review of preclinical and clinical data
- Structurally related compounds will be also considered, and data obtained through in silico analysis will also be included, using QSAR rule-base models (Statistical QSAR and Read Across)
- Estimation of safe exposure limits (STV - Security Threshold Value)
RISK ANALYSIS
Based on the results obtained from the previous steps, for each product in contact with the material under assay, we perform a risk analysis to evaluate the hazards derived from the extractable.
Very often, this risk analysis is sufficient for the regulatory part of the file.
STUDY OF LEACHABLES
Under normal conditions of use, but depending on the results obtained in the risk analysis of extractables, the study of leachable impurities may not be necessary.
You can check Socosur Tox methodology for Extractables and Leachables Risk Assessments, signed by an European Registered Toxicologist expert here.
In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted Socosur Tox is duly accredited for the French Research Tax Credit CIR.
Feel free to contact us using this email link to receive a quotation for Tox Extractables and Leachables procedure used on your manufacturing line.