Fecha registrada: July 30 2015
Duration: 41 minutes 34 seconds
Product quality and safety concerns have driven the enumeration of particulate species in injectable products. Guidelines, such as USP<787>, <788>, and <790>, describe methods for collecting accurate particle count and size data in the sub-visible and visible ranges, and call for the use of microscopic techniques, among others. However, absolute identification of particulates is not currently required, even though such information can be inherently critical to root cause analysis. Hybrid automated microscopic-spectroscopic systems are capable of providing both particulate enumeration and identification well into the sub-visible range, extending the potential of routine counting to include explicit chemistry. This webinar will discuss improvements in sample presentation for both suspended and filtered samples, and provide application examples of biotherapeutic relevance using these new methods.