An analysis of approximately 2000 syringes showed no negative impact on key product functions when stored at -20°C and -40°C
BD (Becton, Dickinson and Company), a global medtech company, has completed a preliminary study investigating the impact of deep cold storage (-20°C and -40°C) on glass PFS.
While traditional vaccine formulations are commonly stored up to about 2°C-8°C, many recent vaccine formulations – including those for mRNA – require much colder storage for long periods of time to ensure shelf-life and potency. These 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 integrity. The company began its investigation in 2020.
BD researchers analysed 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 methods including Lighthouse Laser Headspace Analysis.
The study showed key product functions were unaltered when stored at -20°C and -40°C. In addition, the count of subvisible particles and container closure integrity remained unchanged when compared to those stored at room temperature.
“PFS are a known factor in addressing the complexity and costs of vaccine administration. They have been shown to significantly reduce time and labour associated with drug preparation compared to vial formats, and they support dose sparing,” said Bruno Baney, VP of R&D for Pharmaceutical Systems at BD. “This study confirms the promising opportunity we have to apply our leading scientific capabilities to develop innovative delivery solutions for our customers now and in the future. We’re encouraged by these results and look forward to partnering with pharmaceutical companies to further advance PFS in deep cold conditions.”
Following its completion of this study, the company says its glass barrel PFS systems should be suitable for use when storage temperatures of -20°C and -40°C are required.