Silicone Layer and Subvisible Particle Control

The workshops start with theory, strategy and the discussion of the current FDA regulations [USP<788>/<1788> and USP<787>/<1787>guidelines] and methods for biophysical characterization. Follwed by extensive hands on training on each of the techniques: MDRS, FlowCam, Layer Explorer.

This workshop provides a significant amount of knowledge relevant to silicone layer characterization and its impact on protein stability.

Technologies attendees work with their samples are:

  • Layer Explorer BI -> visualizing the homogeneity of the silicone layer
  • FlowCam 8100 -> visualizing silicone in the formulation and protein aggregates
  • wet-dispersion.AID + SPE ls raman.ID 5 -> Morphology Directed Raman Spectroscopy (chemical characterization and identification) of aforementioned aggregates, silicone droplets and free fatty acid particles

Attendees will have a full suite of instruments for the hands on session including the rap.ID Single Particle Explorer ls 532, Layer Explorer BI, FlowCam 8100, FTIR and video microscopes.


Take away points:

This one-day comprehensive training program will teach you how to:

  • control and validate the quality parameters in a pre-filled syringe for your PFS stability and compatibility studies.
  • Understand the operation and functionality of the FlowCam and the benefits of morphological differentiation of different types of particles.
  • Investigate subvisible particles materials and differentiate into different catagories by means of highest sensitivity 532 nm Morphology Directed Raman Spectroscopy, MDRS.
  • Hands on experience in the simple and streamlined implementation of USP <787>/USP<1787>.  

Short intro of subvisible particle control:

Training program dates:

21st March 2018

discounts may apply - attending both workshops will give a discount of $100

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