PDA report “This year marks the 2nd edition of the conference on Particles in Injectables in Berlin, 26–27 September, and the 10th Anniversary of PDA Europe‘s Monoclonal Antibodies Workshop. Both events and its respective Education Program will join forces as part of the PDA Exchange meeting format. This meeting format combines two meetings in the same place, allowing the audience to swap between the two meetings and attend different sessions with just one meeting ticket.
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The Particles in Injectables conference provides you with a summary of information on the risks to human health associated with particulate matter. Particles can arise from many sources: foreign, intrinsic, or inherent to the product. Particulate matter, visible or subvisible, in sterile parenteral products is regarded a critical quality attribute, impacting patient safety. A session will focus on the nature and sources of these particles in parenterals and in infusion sets used in clinical studies and hospitals. The difference between particles in drugs and clinical infusions will be highlighted. Furthermore, packaging materials, such as glass vials, syringes and rubber stoppers are known to be major sources of particulate contamination. A session will discuss defects in packaging materials and strategies employed to detect and control them. Last but not least, manual inspection continues to provide the critical reference method for all compendial inspection activity. Therefore, the concluding session will look at the use of particle standards to qualify manual and automated inspection systems, control of critical inspection parameters, as well as the development of an inspection method.”
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