Extractables and Leachables for Parenteral Applications - Korea

When making parenteral drug products, pharmaceutical companies are faced with the regulatory requirements to further investigate the materials that will be in contact with the drug product either during manufacturing, intermediate storage, storage in its final packaging, or during the delivery of the drug to the patient. While historically, the potential safety issues were the main driver in these kinds of investigations, recently, quality issues – i.e. for biopharmaceuticals – have become an additional concern.

This training course will look at Extractables and Leachables (E/L) from many different angles:

• Regulatory Requirements and Guidelines eg. USP <1663> (Extractables Testing), USP <1664> (Leachables Testing), USP <661> (Plastic Packaging Systems), USP<665> versus BPOG (for Single Uses Systems)
• Material & Polymer Science
• Mechanisms of Leaching and Material-Drug Product Interaction
• Analytical E/L Methodologies
• E/L Study Design for Different Packaging Systems
• Large Volume Parenterals
• Lyo Applications

Several interesting case studies on the above topics will also be presented.

1. Identify which regulations are to be followed and what is applicable
2. Recognize the impact of the physicochemical properties of a polymers and their impact on the leachable mechanism
3. Identify which analytical techniques are necessary in a comprehensive E/L program and what they should accomplish
4. Assess the results of an E/L program from a safety perspective
5. Design an E/L study that is compliant with the regulatory requirements, by choosing the right set of testing conditions