RT Journal Article
SR Electronic
T1 Assessment of Functional and Physical performances of Pre-filled Syringes in deep cold storage conditions
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2022.012746
DO 10.5731/pdajpst.2022.012746
A1 Eloise Perrin
A1 Nestor Rodriguez
A1 Kylie E. Van Meter
A1 Guillaume Lehee
A1 Brandon A. Krick
A1 Erwan Chabert
YR 2023
UL http://journal.pda.org/content/early/2023/04/21/pdajpst.2022.012746.abstract
AB The recent emergence of new drug technologies such as mRNA-based (messenger ribonucleic acid) vaccines developed to fight the outbreak of the Corona Virus Disease (COVID-19) global pandemic has driven increased demand for delivery solutions capable of withstanding deep cold storage conditions down to -50°C, and even down to -80°C. While significant data exist for deep cold storage in vials, little evidence is available for pre-filled syringes. Since pre-filled syringes serve as both the storage container and the delivery mechanism, there are additional risks to performance that must be evaluated, such as plunger gliding performance, syringe lubrication, silicone layer stability, and container closure integrity (CCI). In the present study, a comprehensive assessment of functional and physical performances of Pre-Filled Syringes (PFS filled with water) was performed after one or multiple freeze/thaw (F/T) cycles between ambient temperature and various temperature cycles including -40°C, -50°C or -80°C for both ′staked needle′ and ′luer lock′ configurations. The experiments were guided by historical normative methods such as ISO11040-4 and USP<1207> and combined with headspace gas analysis for barrel-stopper tightness testing. In addition, they were complemented with a novel approach namely in situ real time optical imagery to track plunger stopper movement during F/T cycle. The findings indicate that there is no significant impact on the functional performances from F/T down to -80°C, while no CCI risk was found after F/T down to -50°C.