Toxway offers specialized Extractables and Leachables (E&L) Toxicological Risk Assessments to evaluate the safety of packaging materials used in pharmaceutical products. E&L studies are critical for ensuring that packaging materials do not introduce harmful substances into drug products, thereby maintaining product integrity and patient safety.
Our E&L Toxicological Risk Assessment Services Include:
Comprehensive E&L Analysis:
Extractables Testing: We perform thorough testing to identify and quantify extractables from packaging materials under exaggerated conditions. This involves exposing materials to solvents or conditions (e.g., elevated temperature) that mimic worst-case scenarios to determine the potential for substance migration.
Leachables Testing: We analyze the leachables, which are substances that migrate into the drug product under normal storage and use conditions. This involves testing over a defined period to simulate real-life conditions and assess the potential risk of leaching.
Toxicological Evaluation:
Risk Assessment: We assess the toxicological risk associated with the extractables and leachables identified in your packaging materials. This includes evaluating their potential effects on human health based on available toxicity data and exposure levels.
Toxicity Data Review: We review and interpret data from existing toxicological studies or conduct new studies to determine the safety of the extractables and leachables. This includes data on acute toxicity, chronic toxicity, genotoxicity, and reproductive toxicity.
Regulatory Compliance:
Guideline Adherence: Our assessments adhere to industry guidelines and standards for E&L studies, including those set by regulatory bodies such as the FDA, EMA, and ICH. We ensure compliance with relevant standards and provide documentation that meets regulatory requirements.
Standard References: We follow established guidelines such as USP <381> for packaging systems, ISO 10993-18 for biological evaluation of medical devices, and other applicable standards to guide our assessments.
Exposure Assessment:
Dose Calculation: We calculate the potential exposure levels of identified extractables and leachables in the drug product. This involves determining the maximum concentration of leachables and estimating the potential dose based on the product’s use and administration.
Safety Thresholds: We compare exposure levels to established safety thresholds, such as Permitted Daily Exposure (PDE) or Threshold of Toxicological Concern (TTC), to evaluate whether the levels are within acceptable limits.
Material Characterization:
Chemical Profiling: We provide detailed chemical characterization of the extractables and leachables, including their chemical structure, molecular weight, and potential degradation products.
Material Analysis: We analyze the composition of the packaging materials, including polymers, coatings, and additives, to understand their role in the release of extractables and leachables.
Risk Mitigation Strategies:
Material Selection: We recommend alternatives or modifications to packaging materials based on the risk assessment to minimize the potential for harmful extractables and leachables.
Process Improvements: We suggest improvements to manufacturing and packaging processes to reduce the risk of contamination and ensure the safety of the final product.
Documentation and Reporting:
Comprehensive Reports: We provide detailed reports that include the results of the E&L studies, toxicological evaluations, and risk assessments. Our reports offer clear, actionable insights and recommendations for mitigating risks.
Regulatory Submissions: We prepare documentation required for regulatory submissions, including summaries of E&L studies and toxicological assessments, to support product approvals and compliance.
Ongoing Support:
Periodic Reviews: We offer ongoing support to review and update E&L assessments as new data, regulations, or packaging materials become available.
Consultation: We provide expert consultation to address any questions or concerns regarding E&L risks and mitigation strategies.
Why E&L Toxicological Risk Assessment Matters: Ensuring the safety of packaging materials through E&L toxicological risk assessments is essential for protecting patient health and maintaining the quality of pharmaceutical products. By identifying and evaluating potential risks associated with extractables and leachables, ToxWay helps you ensure that your packaging materials do not introduce harmful substances into drug products. Our comprehensive assessments, aligned with regulatory guidelines, provide the necessary evidence to support product safety and facilitate regulatory approvals, ultimately safeguarding patients and ensuring compliance with industry standards.
For more information about our services or to request a consultation, contact us at info@toxway.com
