• West: Assessment of CCI of various stopper, vial, and stopper blowback feature combinations. Samples with air headspace stored in nitrogen environment for four weeks: 5 of 240 samples showed evidence of a leak (drop in oxygen concentration between 1.3% and 3.4% atm). Results used by West for marketing poster.
CCIT, Dry Ice
• BioMarin: 130 glass vials with liquid (diluent) stored for two weeks on dry ice. Correction of total pressure measurement for carbon dioxide ingress into positive controls indicated reduced pressure instead of over-pressure – result attributed to significant solubility of carbon dioxide in water at room temperature. Results highlight pH change of liquid product as potential hazard of leak during dry ice storage. …show more content…
1 of 30 blow-fill-seal vials leaked to over 50 torr CO2 during second storage period. Permeation of CO2 at -78.5˚C was measurable (~3 torr after 2 weeks) and rate appeared to increase during second storage period. Results suggest thermal cycling of blow-fill seal vials may be important to vial integrity. Samples highly permeable to CO2 at room temperature (~500 torr in 2 weeks).
In Process Testing:
• Durect: Oxygen analysis of samples known to contain ethanol - example of possible ethanol broadening of the oxygen signal for headspace of air at ~1 atm.
• Baxalta: Correlation between stopper height above vial rim and leak probability. Leaks identified by oxygen ingress into nitrogen purged samples. Customer plans to use information from a second, larger study to inform production line acceptance criteria based on stopper height prior to the capping step.
Development (Permeation):
• Unilife: Syringe plunger permeability study at 40˚C. Permeation data well described by leak rate model.
Development (Stability):
• Flexion: Lighthouse purged customer product vials to various oxygen concentrations for product stability study. Project performed to help customer determine headspace oxygen reject limit based on product stability
CCIT, Dry Ice
• BioMarin: 130 glass vials with liquid (diluent) stored for two weeks on dry ice. Correction of total pressure measurement for carbon dioxide ingress into positive controls indicated reduced pressure instead of over-pressure – result attributed to significant solubility of carbon dioxide in water at room temperature. Results highlight pH change of liquid product as potential hazard of leak during dry ice storage. …show more content…
1 of 30 blow-fill-seal vials leaked to over 50 torr CO2 during second storage period. Permeation of CO2 at -78.5˚C was measurable (~3 torr after 2 weeks) and rate appeared to increase during second storage period. Results suggest thermal cycling of blow-fill seal vials may be important to vial integrity. Samples highly permeable to CO2 at room temperature (~500 torr in 2 weeks).
In Process Testing:
• Durect: Oxygen analysis of samples known to contain ethanol - example of possible ethanol broadening of the oxygen signal for headspace of air at ~1 atm.
• Baxalta: Correlation between stopper height above vial rim and leak probability. Leaks identified by oxygen ingress into nitrogen purged samples. Customer plans to use information from a second, larger study to inform production line acceptance criteria based on stopper height prior to the capping step.
Development (Permeation):
• Unilife: Syringe plunger permeability study at 40˚C. Permeation data well described by leak rate model.
Development (Stability):
• Flexion: Lighthouse purged customer product vials to various oxygen concentrations for product stability study. Project performed to help customer determine headspace oxygen reject limit based on product stability