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Subvisible Particle Characterization
Subvisible particle characterization studies and compliant control strategies
Subvisible Particle Characterization
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Support the setup of a compliant SVP control strategy
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Polysorbate related free fatty acid particle RCI, CGT Products, etc
State of the art SVP methodologies to cover the complete size range
Development of product-specific AI models for flow imaging microscopy particle classification, including experimental and computational support
Setup of a compliant particle control strategy, health authority communication, support in particle root cause investigations
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SVP analytical method development for highly viscose, turbid or low volume
products, pharmacopoeial microscopic method development, compendial method verification
Related Scientific Bulletins on Subvisible
Particle Characterization
Visual Inspection Test Sets
Design, manufacturing, qualification and certification of visual inspection test sets
Facility Material Reference Libraries
Building a facility particle library is the foundation for effective particle control and a risk-based approach to quality management.
Particle Control for Cell Therapy Products
Challenges and mitigation strategies for particle control in Cell Therapy products