Flexible bag systems for large volume parenterals (LVPs) are subject to stringent regulatory oversight for extractables and leachables (E&L) testing due to the potential for high dose exposure. Given the low Analytical Evaluation Thresholds (AETs) required for such applications, the analytical and toxicological workload is substantial. To efficiently identify problematic product components, extractables studies for flexible bag systems should include all components of the packaging system, even those with minimal product contact, such as ports, secondary packaging, and overwrap.
A recommended three-step approach to E&L testing for flexible bag systems involves a comprehensive evaluation at multiple levels:
- Materials Assessment: This step involves conducting a controlled, worst-case extraction study of individual components of the packaging system. By isolating and testing each component, potential extractables can be identified and quantified, ensuring that all possible sources of contamination are considered.
- Packaging Assessment: This step involves a real-world simulation study of the entire flexible bag system. This assessment replicates the conditions under which the product will be stored and used, providing a realistic evaluation of how the entire system behaves and identifying any extractables that may arise from the interaction of different components.
- Product Assessment: This final step involves a leachables study using the potential leachables identified in the packaging assessment. By analyzing the product under actual usage conditions, this assessment ensures that any leachables that may migrate into the drug product are detected and evaluated for safety.
By following this three-step approach, manufacturers can ensure that flexible bag systems for LVPs meet regulatory requirements and maintain the highest standards of safety and efficacy. This comprehensive testing strategy helps identify and mitigate potential risks, safeguarding patient health and ensuring compliance with stringent regulatory standards.
This presentation is essential for professionals involved in the development, testing, and regulatory compliance of flexible bag systems for LVPs. By attending, participants will gain valuable insights into effective E&L testing methodologies, helping to ensure the safety and regulatory compliance of their products.