USP Particulate Testing
Join us as speaker Mark Bumiller, technology manager at Entegris, discusses particle sizing methodology, equipment selection, software validation, and compliance to meet the USP standards for parenteral drug manufacture, proteins, ophthalmic solutions and lipid emulsions.
- Requirements of USP <788>, <787>, <789>, and <729>
- Improvements in sensors, calibration, and software
- An overview of each of these USP standards, instrument and sensor selection, protocols, software, and reporting
- The sizing of lipid emulsions
- Automated testing options
Mark Bumiller | Entegris Technology Manager
Mark has worked in the field of particle size analysis for over 35 years. Positions held include product manager at Hiac Royco (5 years), technical support manager and vice president of business development at Malvern Instruments (17 years), vice president of particle products at Horiba (6 years) and technology manager at Particle Sizing Systems, LLC, and now Entegris (6 years). He has served as a member of the expert committee for USP <788>, the executive committee of the International Fine Particle Research Institute (IFPRI), and the executive committee of Particle Technology Forum of the American Institute of Chemical Engineers. Mark is an active member of Technical Committee 24 within ISO helping to write standards for particle size and zeta potential analysis. His B.S. in chemical engineering was earned at Carnegie Mellon University in Pittsburgh, PA.