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

doi:10.5731/pdajpst.2022.012746

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Keywords

[1] 1.↵
Uddin M. N.,
Roni M. A.
Challenges of Storage and Stability of mRNA-Based COVID-19 Vaccines. Vaccines (Basel, Switz.) 2021, 9 (9), 1033.
OpenUrl

[2] Uddin M. N.,

[3] Roni M. A.

[4] 2.↵
Baden L. R.,
El Sahly H. M.,
Essink B.,
Kotloff K.,
Frey S.,
Novak R.,
Diemert D.,
Spector S. A.,
Rouphael N.,
Creech C. B.,
McGettigan J.,
Khetan S.,
Segall N.,
Solis J.,
Brosz A.,
Fierro C.,
Schwartz H.,
Neuzil K.,
Corey L.,
Gilbert P.,
Janes H.,
Follmann D.,
Marovich M.,
Mascola J.,
Polakowski L.,
Ledgerwood J.,
Graham B. S.,
Bennett H.,
Pajon R.,
Knightly C.,
Leav B.,
Deng W.,
Zhou H.,
Han S.,
Ivarsson M.,
Miller J.,
Zaks T.
Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N. Engl. J. Med. 2021, 384 (5), 403–416.
OpenUrl CrossRef PubMed

[5] Baden L. R.,

[6] El Sahly H. M.,

[7] Essink B.,

[8] Kotloff K.,

[9] Frey S.,

[10] Novak R.,

[11] Diemert D.,

[12] Spector S. A.,

[13] Rouphael N.,

[14] Creech C. B.,

[15] McGettigan J.,

[16] Khetan S.,

[17] Segall N.,

[18] Solis J.,

[19] Brosz A.,

[20] Fierro C.,

[21] Schwartz H.,

[22] Neuzil K.,

[23] Corey L.,

[24] Gilbert P.,

[25] Janes H.,

[26] Follmann D.,

[27] Marovich M.,

[28] Mascola J.,

[29] Polakowski L.,

[30] Ledgerwood J.,

[31] Graham B. S.,

[32] Bennett H.,

[33] Pajon R.,

[34] Knightly C.,

[35] Leav B.,

[36] Deng W.,

[37] Zhou H.,

[38] Han S.,

[39] Ivarsson M.,

[40] Miller J.,

[41] Zaks T.

[42] 3.↵
Polack F. P.,
Thomas S. J.,
Kitchin N.,
Absalon J.,
Gurtman A.,
Lockhart S.,
Perez J. L.,
Pérez Marc G.,
Moreira E. D.,
Zerbini C.,
Bailey R.,
Swanson K. A.,
Roychoudhury S.,
Koury K.,
Li P.,
Kalina W. V.,
Cooper D.,
Frenck R. W. Jr.,
Hammitt L. L.,
Türeci Ö.,
Nell H.,
Schaefer A.,
Ünal S.,
Tresnan D. B.,
Mather S.,
Dormitzer P. R.,
Şahin U.,
Jansen K. U.,
Gruber W. C.
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N. Engl. J. Med. 2020, 383 (27), 2603–2615.
OpenUrl CrossRef PubMed

[43] Polack F. P.,

[44] Thomas S. J.,

[45] Kitchin N.,

[46] Absalon J.,

[47] Gurtman A.,

[48] Lockhart S.,

[49] Perez J. L.,

[50] Pérez Marc G.,

[51] Moreira E. D.,

[52] Zerbini C.,

[53] Bailey R.,

[54] Swanson K. A.,

[55] Roychoudhury S.,

[56] Koury K.,

[57] Li P.,

[58] Kalina W. V.,

[59] Cooper D.,

[60] Frenck R. W. Jr.,

[61] Hammitt L. L.,

[62] Türeci Ö.,

[63] Nell H.,

[64] Schaefer A.,

[65] Ünal S.,

[66] Tresnan D. B.,

[67] Mather S.,

[68] Dormitzer P. R.,

[69] Şahin U.,

[70] Jansen K. U.,

[71] Gruber W. C.

[72] 4.↵
Covid Vaccine Tracker. Bloomberg Web site. https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/ (accessed November 9, 2021).

[73] 5.↵
Moo-Young M.
Chen S.,
Ren J.,
Chen R.
Cryopreservation and Desiccation Preservation of Cells. In Comprehensive Biotechnology, 3rd ed.; Moo-Young M., Ed.; Pergamon, 2019; pp 157–164.

[74] Moo-Young M.

[75] Chen S.,

[76] Ren J.,

[77] Chen R.

[78] 6.↵
Ball R. L.,
Bajaj P.,
Whitehead K. A.
Achieving Long-Term Stability of Lipid Nanoparticles: Examining the Effect of pH, Temperature, and Lyophilization. Int. J. Nanomed. 2016, 12, 305–315.
OpenUrl

[79] Ball R. L.,

[80] Bajaj P.,

[81] Whitehead K. A.

[82] 7.↵
Hunt C. J.
Technical Considerations in the Freezing, Low-Temperature Storage and Thawing of Stem Cells for Cellular Therapies. Transfus. Med. Hemother. 2019, 46 (3), 134–150.
OpenUrl

[83] Hunt C. J.

[84] 8.↵
Rosell-Valle C.,
Antúnez C.,
Campos F.,
Gallot N.,
García-Arranz M.,
García-Olmo D.,
Gutierrez R.,
Hernán R.,
Herrera C.,
Jiménez R.,
Leyva-Fernández L.,
Maldonado-Sanchez R.,
Muñoz-Fernández R.,
Nogueras S.,
Ortiz L.,
Piudo I.,
Ranchal I.,
Rodríguez-Acosta A.,
Segovia C.,
Fernández-Muñoz B.
Evaluation of the Effectiveness of a New Cryopreservation System Based on a Two-Compartment Vial for the Cryopreservation of Cell Therapy Products. Cytotherapy 2021, 23 (8), 740–753.
OpenUrl

[85] Rosell-Valle C.,

[86] Antúnez C.,

[87] Campos F.,

[88] Gallot N.,

[89] García-Arranz M.,

[90] García-Olmo D.,

[91] Gutierrez R.,

[92] Hernán R.,

[93] Herrera C.,

[94] Jiménez R.,

[95] Leyva-Fernández L.,

[96] Maldonado-Sanchez R.,

[97] Muñoz-Fernández R.,

[98] Nogueras S.,

[99] Ortiz L.,

[100] Piudo I.,

[101] Ranchal I.,

[102] Rodríguez-Acosta A.,

[103] Segovia C.,

[104] Fernández-Muñoz B.

[105] 9.↵
Zuleger B.,
Werner U.,
Kort A.,
Glowienka R.,
Wehnes E.,
Duncan D.
Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at −80°C. PDA J. Pharm. Sci. Technol. 2012, 66 (5), 453–465.
OpenUrl Abstract/FREE Full Text

[106] Zuleger B.,

[107] Werner U.,

[108] Kort A.,

[109] Glowienka R.,

[110] Wehnes E.,

[111] Duncan D.

[112] 10.↵
Zhao J.,
Lavalley V.,
Mangiagalli P.,
Wright J. M.,
Bankston T. E.
Glass Delamination: A Comparison of the Inner Surface Performance of Vials and Pre-Filled Syringes. AAPS PharmSciTech 2014, 15 (6), 1398–1409.
OpenUrl

[113] Zhao J.,

[114] Lavalley V.,

[115] Mangiagalli P.,

[116] Wright J. M.,

[117] Bankston T. E.

[118] 11.↵
Ingle R. G.,
Agarwal A. S.
Pre-Filled Syringe - a Ready-to-Use Drug Delivery System: A Review. Expert Opin. Drug Delivery 2014, 11 (9), 1391–1399.
OpenUrl

[119] Ingle R. G.,

[120] Agarwal A. S.

[121] 12.↵
Icardi G.,
Orsi A.,
Vitali Rosati G.,
Tognetto A.,
Checcucci Lisi G.,
Parisi S.
Preferences of Healthcare Professionals regarding Hexavalent Pediatric Vaccines in Italy: A Survey of Attitudes and Expectations. J. Prev. Med. Hyg. 2020, 61 (3), E424–E444.
OpenUrl

[122] Icardi G.,

[123] Orsi A.,

[124] Vitali Rosati G.,

[125] Tognetto A.,

[126] Checcucci Lisi G.,

[127] Parisi S.

[128] 13.↵
Moreira M. E.,
Hernandez C.,
Stevens A. D.,
Jones S.,
Sande M.,
Blumen J. R.,
Hopkins E.,
Bakes K.,
Haukoos J. S.
Color-Coded Prefilled Medication Syringes Decrease Time to Delivery and Dosing Error in Simulated Emergency Department Pediatric Resuscitations. Ann. Emerg. Med. 2015, 66 (2), 97–106.e3.
OpenUrl CrossRef PubMed

[129] Moreira M. E.,

[130] Hernandez C.,

[131] Stevens A. D.,

[132] Jones S.,

[133] Sande M.,

[134] Blumen J. R.,

[135] Hopkins E.,

[136] Bakes K.,

[137] Haukoos J. S.

[138] 14.↵
Makwana S.,
Basu B.,
Makasana Y.,
Dharamsi A.
Prefilled Syringes: An Innovation in Parenteral Packaging. Int. J. Pharm. Invest. 2011, 1 (4), 200–206.
OpenUrl

[139] Makwana S.,

[140] Basu B.,

[141] Makasana Y.,

[142] Dharamsi A.

[143] 15.↵
Lloyd A. J.,
Nafees B.,
Ziani E.,
Nicolas L.,
Fordham B. A.,
Soubeyrand B.,
Bornhöft C.
What Are the Preferences of Health Care Professionals in Germany Regarding Fully Liquid, Ready-to-Use Hexavalent Pediatric Vaccine versus Hexavalent Pediatric Vaccine That Needs Reconstitution? Patient Preference Adherence 2015, 9, 1517–1524.
OpenUrl

[144] Lloyd A. J.,

[145] Nafees B.,

[146] Ziani E.,

[147] Nicolas L.,

[148] Fordham B. A.,

[149] Soubeyrand B.,

[150] Bornhöft C.

[151] 16.↵
Pereira C. C.,
Bishai D.
Vaccine Presentation in the USA: Economics of Prefilled Syringes versus Multidose Vials for Influenza Vaccination. Expert Rev. Vaccines 2010, 9 (11), 1343–1349.
OpenUrl PubMed

[152] Pereira C. C.,

[153] Bishai D.

[154] 17.↵
U.S. Pharmacopeial Convention, General Chapter <1207> Sterile Product Packaging—Integrity Evaluation. In USP 42—NF 37, USP: Rockville, MD, 2019.

[155] 18.↵
Peláez S. S.,
Mahler H.-C.,
Matter A.,
Koulov A.,
Singh S. K.,
Germershaus O.,
Mathaes R.
Container Closure Integrity Testing of Prefilled Syringes. J. Pharm. Sci. 2018, 107 (8), 2091–2097.
OpenUrl PubMed

[156] Peláez S. S.,

[157] Mahler H.-C.,

[158] Matter A.,

[159] Koulov A.,

[160] Singh S. K.,

[161] Germershaus O.,

[162] Mathaes R.

[163] 19.↵
Chan E.,
Maa Y.-F.,
Overcashier D.,
Hsu C. C.
Investigating Liquid Leak from Pre-Filled Syringes upon Needle Shield Removal: Effect of Air Bubble Pressure. PDA J. Pharm. Sci. Technol. 2011, 65 (4), 363–371.
OpenUrl Abstract/FREE Full Text

[164] Chan E.,

[165] Maa Y.-F.,

[166] Overcashier D.,

[167] Hsu C. C.

[168] 20.↵
Thakare V.,
Mayr B.,
Artenjak A.,
Nianios D.,
Sest M.,
Müller M.,
Maltsev O. V.,
Nowicki K.,
Mischo A.,
Ehrenstrasser C.,
Fink M.,
Thanhaeuser S.,
Cerreti A.
Investigation of Drug Product and Container-Closure Interactions: A Case Study of Diluent Containing Prefilled Syringe. Eur. J. Pharm. Biopharm. 2019, 140, 67–77.
OpenUrl

[169] Thakare V.,

[170] Mayr B.,

[171] Artenjak A.,

[172] Nianios D.,

[173] Sest M.,

[174] Müller M.,

[175] Maltsev O. V.,

[176] Nowicki K.,

[177] Mischo A.,

[178] Ehrenstrasser C.,

[179] Fink M.,

[180] Thanhaeuser S.,

[181] Cerreti A.

[182] 21.↵
Yoshino K.,
Nakamura K.,
Yamashita A.,
Abe Y.,
Iwasaki K.,
Kanazawa Y.,
Funatsu K.,
Yoshimoto T.,
Suzuki S.
Functional Evaluation and Characterization of a Newly Developed Silicone Oil-Free Prefillable Syringe System. J. Pharm. Sci. 2014, 103 (5), 1520–1528.
OpenUrl PubMed

[183] Yoshino K.,

[184] Nakamura K.,

[185] Yamashita A.,

[186] Abe Y.,

[187] Iwasaki K.,

[188] Kanazawa Y.,

[189] Funatsu K.,

[190] Yoshimoto T.,

[191] Suzuki S.

[192] 22.↵
Lehee G.,
et al
. Investigation on Impact of Deep Cold Storage on All Glass PFS Technologies – Risk Assessment Study. 2021 PDA Universe of Pre-Filled Syringes and Injection Devices, Virtual, October 5–6, 2021.

[193] Lehee G.,

[194] et al

[195] 23.↵
Reuter B.,
Petersen C.
Syringe Siliconization Trends, Methods, Analysis Procedures. TechnoPharm 2012, 2 (4), 238–244.
OpenUrl

[196] Reuter B.,

[197] Petersen C.

[198] 24.↵
Victor K. G.,
Levac L.,
Timmins M.,
Veale J.
Method Development for Container Closure Integrity Evaluation via Gas Ingress by Using Frequency Modulation Spectroscopy. PDA J. Pharm. Sci. Technol. 2017, 71 (6), 429–453.
OpenUrl Abstract/FREE Full Text

[199] Victor K. G.,

[200] Levac L.,

[201] Timmins M.,

[202] Veale J.

[203] 25.↵
Lorenz B.,
Krick B. A.,
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