ECA - Leachables & Extractables - Testing & Assessment

Art-No.: A-873
Date: 21.-23. May 2019

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
11152Introduction to Plastics construction and related additives048
11153Regulatory Requirements for Extractables/Leachables Testing066
11154Principle Organisation of E&L Assessments - an overview Practical aspects beyond theory042
11155Routine Extractables Testing in Quality Control049
11156Interference of Leachables with Biopharmaceuticals during Manufacturing, Storage and Administration026
11159L+E Strategies in Practice060
11161Extractables from Glass045
11162Extractables from Elastomers - Parenteral Packaging Testing020
11648Leachables during Manufacturing054
11650E&L Assessment for Aqueous, Protein based drug products for Critical Care, Immunotherapy and Hematology. The Biopharmaceutical Manufacturer's Perspective029
11651Workshop:Strategy for compliant/ reasonable leachables studies00
14267Workshop: Single Use00
14704Determining the Suitability of Packaging Systems for Therapeutic Products: Compendial Perspective051
14705Extractables and Leachables Testing in packaging Material, Correlation between Extractables & Leachables, Leachables strategies034
14706Toxicological Assessment of Leachables and Extractables Studies033
14707A reasonable E&L Design for complex products045
14708USP strategy for developing standard for plastic components and systems used on the manufacturing of a drug product056

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