BD (Becton, Dickinson and Company) has completed a preliminary study investigating the impact of deep cold storage (-20°C and -40°C) on glass prefillable syringes (PFS).
While traditional vaccine formulations are commonly stored up to about 2°C-8°C, new vaccine formulations – including those for mRNA – require much colder storage for over a long period of time to ensure drug-product shelf-life and potency. Such low temperatures can induce changes in container dimensions, phase transition - liquid to solid and vice versa - and thermal shock. This could compromise the functional performance of the delivery system and Container Closure Integrity (CCI). BD began its investigation on the impact of deep cold storage on glass PFS as soon as information regarding the deep cold storage requirement for mRNA COVID-19 vaccines became available in 2020.
BD researchers conducted a comprehensive analysis of approximately 2,000 PFS after deep cold storage at -20°C and -40°C. Tests were conducted on several combinations of glass barrel coatings, formats - from 0.5 to 3 mL -, different tip and flange designs, and multiple elastomeric closures with various state-of-the-art methods, including Lighthouse Laser Headspace Analysis, at these temperatures.
The study showed key product functions – PFS system level – were unaltered when stored at -20°C and -40°C. In addition, the count of subvisible particles and container closure integrity (CCI) remained unchanged when compared to those stored at room temperature.
Following its completion of this study, BD anticipates that BD glass barrel PFS systems should be suitable for use when storage temperatures of -20°C and -40°C are required.
