Intertek is the industry leader with over 42,000 people in 1,000 locations in over 100 countries. Whether your business is local or global, we can ensure your products meet quality, health, environmental, safety, and social accountability standards for virtually any market around the world.
Annual Extractables & Leachables and Packaging for Parenterals Summit
We will present at the Annual Extractables & Leachables Summit and the Packaging for Parenterals Summit, Berlin, Oct 19 -20
Intertek's Extractables & leachables expert, Tino Otte, Intertek (Schweiz) AG, will present during both the Annual Extractables & Leachables Summit and the co-located event, Packaging for Parenterals Summit in Berlin, Germany.
Annual Extractables & Leachables Summit This event provides the appropriate platform to discuss and network with peers involved in pharmaceutical manufacturing, toxicology, quality control, devices, single-use systems, and equipment and container development. The Summit will shed light on guideline updates, analytical testing innovations, and the impact of Extractables and Leachables (E&L) on biologics safety.
Presentation Title: E&L test strategies and case studies for complex packaging systems and process contact materials This talk will cover:
Summary of the different steps to be addressed for a proper Extractables-Leachables Screening Study
Illustration of different study designs which may be applied for complex materials consisting of different parts
Importance of a Leachables check experiment as part of the formal Extractables screening study with special attention to migration and ink/adhesive-related Extractables
Case studies/examples of complex materials, such as, nasal spray device, multilayer bag from single use dosage system, examples of real Extractables from printing
Packaging for Parenterals Summit This event provides the appropriate platform to discuss and network with peers involved in parenteral manufacturing, packaging, quality control, container development and regulatory affairs. The Summit will shed light on regulatory updates, CCI testing, variety of materials and their characteristics, drug stability, and primary and secondary packaging.
Glass delamination studies for pharmaceutical vials – a general strategy This talk will cover:
General risks to production and patient safety
Factors contributing to glass delamination
Analytical assessment for minimising the risk - with examples
Our experts have over 25 years’ experience in specialised analytical assessment for extractables and leachables, and this is reinforced by our knowledge of polymer, plastic and packaging materials, allowing us to identify components from the most complex polymer formulation including adhesives, additives and stabilizer ingredients and their degradation products. We also provide expertise in and glass delamination studies, helping you to mitigate the risks associated glass delamination and leaching of metal ions /elemental impurities from glass into drug products.