* What do other companies do for testing and investigating visible particles in lyophilized injectables upon observation after reconstitution for stability appearance testing? * How many vials are tested at each time point during routine stability testing for this attribute? * Are additional vials tested if a particle is observed during stability testing? Thank You, Jeremy Pariseau, Scientist I, Global Stability Biogen, Inc. 225 Binney Street Cambridge, MA 02142 Phone: 617-679-3617 [log in to unmask] ================================= The nature of this service is to provide a medium for communication. The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PSDG, or the sponsors of the list. ------------------ The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) and supported by our sponsors as a service to the scientific community. Please take a second to visit our sponsors' web sites and say thank you for their support of this service. Avista Pharma Solutions - http://www.avistapharma.com/ Comprehensive testing and CMC services organization Analytical and Microbiology support to early stage API and drug product development and manufacturing. BahnsonEnvironmental Specialties - http://www.eschambers.com/ Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration Cincinnati Sub-Zero - http://www.cszindustrial.com/ Provides a large selection of environmental chambers from benchtop, reach in to walk-in rooms along with chambers for freeze/thaw, temperature cycling applications.