Container/closure integrity testing and the identification of a suitable vial/stopper combination for low-temperature storage at -80 °C

PDA Journal of Pharmaceutical Science and Technology

Volumn 66, Issue 5, 2012, Pages 453-465

  Zuleger, Brigitte ^a   Werner, Uwe ^a   Kort, Alexander ^b   Glowienka, Rene ^b   Wehnes, Engelbert ^a   Duncan, Derek ^c  

^a Bavarian Nordic GmbH   (Germany)

^b IDT Biologika GmbH   (Germany)

^c Science Park 406   (Netherlands)

Author keywords

Container closure integrity; Frequency modulation spectroscopy; Glass transition temperature; Headspace analysis; Live viral vaccines; Storage at 80 C

Indexed keywords

BUFFER; SODIUM CHLORIDE; GLASS; RUBBER;

AIR TEMPERATURE; ANALYTIC METHOD; ARTICLE; ATMOSPHERIC PRESSURE; CONTAINER; DRUG STORAGE; ELASTICITY; GLASS TRANSITION TEMPERATURE; LABORATORY DEVICE; LOW TEMPERATURE PROCEDURES; PRESSURE; QUALITY CONTROL; STORAGE TEMPERATURE; VIRAL VACCINE PRODUCT VIAL; CHEMICAL PHENOMENA; COLD; DRUG PACKAGING; HUMAN; MATERIALS TESTING; NEAR INFRARED SPECTROSCOPY; TEMPERATURE;

COLD TEMPERATURE; DRUG PACKAGING; GLASS; HUMANS; HYDROPHOBIC AND HYDROPHILIC INTERACTIONS; MATERIALS TESTING; QUALITY CONTROL; RUBBER; SPECTROSCOPY, NEAR-INFRARED; TEMPERATURE;

EID: 84867797846     PISSN: 10797440     EISSN: 19482124     Source Type: Journal    
DOI: 10.5731/pdajpst.2012.00884     Document Type: Article

References (10)

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