Effect of stopper processing conditions on moisture content and ramifications for lyophilized products: Comparison of "low" and "high" moisture uptake stoppers

PDA Journal of Pharmaceutical Science and Technology

Volumn 61, Issue 1, 2007, Pages 51-58

  Donovan, P D ^a   Corvari, V ^a   Burton, M D ^a   Rajagopalan, N ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

Closures; Karl Fisher; Lyophilization; Moisture transfer; Stability; Stoppers

Indexed keywords

DRUG; LACTOSE;

ARTICLE; COMPARATIVE STUDY; DEVICE; FREEZE DRYING; HEATING; MOISTURE; PROCESSING; SHELF LIFE; STORAGE; STORAGE TEMPERATURE; TEMPERATURE SENSITIVITY; WATER CONTENT; WATER VAPOR;

DRUG STABILITY; DRUG STORAGE; ELASTOMERS; FREEZE DRYING; KINETICS; PHARMACEUTICAL PREPARATIONS; RISK ASSESSMENT; STERILIZATION; TEMPERATURE; TIME FACTORS; TITRIMETRY; WATER;

EID: 33847664625     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (11)

1. Earle J. P.; Bennett, P. S.; Larson, K. A.; Shaw, R. The effects of stopper drying on moisture levels of Haemophilus influenzae conjugate vaccine. Develop. Biol. Standard 1990, 74, 203-210.
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11. Injection Containers for Injectables and Accessories. Part 5: Freeze Drying Closures for Injection Vials, ISO 8362-5:1995(E).