PDA Letter Article

Reconstitution and Storage Times for Lyo Products

by Tony Cundell, PhD, Microbiological Consulting, LLC

syringe and vials

A Review of Relevant Literature on Reconstitution and Storage Conditions

Lack of regulatory guidance around the reconstitution and storage conditions for lyophilized products, coupled with unofficial yet stringent recommendations for storage times based on laboratory studies, has resulted in inconsistent product labeling. In the process, it also may have increased product contamination, particularly in hospital settings.