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Research ArticleResearch

Assessment of Functional and Physical Performances of Pre-filled Syringes in Deep Cold Storage Conditions

Eloïse Perrin, Nestor Rodriguez, Kylie E. Van Meter, Guillaume Lehee, Brandon A. Krick and Erwan Chabert
PDA Journal of Pharmaceutical Science and Technology July 2023, 77 (4) 281-295; DOI: https://doi.org/10.5731/pdajpst.2022.012746
Eloïse Perrin
1Becton Dickinson, 11 Rue Aristide Berges, 38800 Le Pont-de-Claix, France;
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  • For correspondence: eloise.perrin@bd.com
Nestor Rodriguez
2Becton Dickinson, 1 Becton Drive, Franklin Lakes, NJ 07407; and
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Kylie E. Van Meter
3Florida Agricultural and Mechanical University—Florida State University College of Engineering, 2003 Levy Avenue, Tallahassee, FL 32310
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Guillaume Lehee
1Becton Dickinson, 11 Rue Aristide Berges, 38800 Le Pont-de-Claix, France;
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Brandon A. Krick
3Florida Agricultural and Mechanical University—Florida State University College of Engineering, 2003 Levy Avenue, Tallahassee, FL 32310
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Erwan Chabert
1Becton Dickinson, 11 Rue Aristide Berges, 38800 Le Pont-de-Claix, France;
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Abstract

The recent emergence of new drug technologies such as messenger ribonucleic acid-based vaccines developed to fight the outbreak of the 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. Although significant data exist for deep cold storage in vials, little evidence is available for pre-filled syringes. Because 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 ISO 11040-4 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 the F/T cycle. The findings indicated that there is no significant impact on the functional performances from F/T down to −80°C, whereas no CCI risk was found after F/T down to −50°C.

  • Pre-fillable syringes
  • Pre-filled syringes
  • PFS
  • Cold storage
  • Container closure integrity (CCI)
  • Silicone oil
  • Freeze and Thaw (F/T)
  • Plunger stopper
  • Tightness
  • Functional performance
  • Optical imagery
  • © PDA, Inc. 2023
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PDA Journal of Pharmaceutical Science and Technology: 77 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 4
July/August 2023
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Assessment of Functional and Physical Performances of Pre-filled Syringes in Deep Cold Storage Conditions
Eloïse Perrin, Nestor Rodriguez, Kylie E. Van Meter, Guillaume Lehee, Brandon A. Krick, Erwan Chabert
PDA Journal of Pharmaceutical Science and Technology Jul 2023, 77 (4) 281-295; DOI: 10.5731/pdajpst.2022.012746
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Keywords

  • Pre-fillable syringes
  • Pre-filled syringes
  • PFS
  • Cold storage
  • Container closure integrity (CCI)
  • Silicone oil
  • Freeze and Thaw (F/T)
  • Plunger stopper
  • Tightness
  • Functional performance
  • Optical imagery

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Assessment of Functional and Physical Performances of Pre-filled Syringes in Deep Cold Storage Conditions
Eloïse Perrin, Nestor Rodriguez, Kylie E. Van Meter, Guillaume Lehee, Brandon A. Krick, Erwan Chabert
PDA Journal of Pharmaceutical Science and Technology Jul 2023, 77 (4) 281-295; DOI: 10.5731/pdajpst.2022.012746

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