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1

Effect of the design of the stopper including dimension, type, and vent area on lyophilization process.

Mungikar A, Ludzinski M, Kamat M. Mungikar A, et al. PDA J Pharm Sci Technol. 2010 Nov-Dec;64(6):507-16. PDA J Pharm Sci Technol. 2010. PMID: 21502061

2

Evaluation of manometric temperature measurement as a method of monitoring product temperature during lyophilization.

Milton N, Pikal MJ, Roy ML, Nail SL. Milton N, et al. PDA J Pharm Sci Technol. 1997 Jan-Feb;51(1):7-16. PDA J Pharm Sci Technol. 1997. PMID: 9099059

3

Novel Mechanism of Glass Delamination in Type 1A Borosilicate Vials Containing Frozen Protein Formulations.

Jiang G, Goss M, Li G, Jing W, Shen H, Fujimori K, Le L, Wong L, Wen ZQ, Nashed-Samuel Y, Riker K, Germansderfer A, Tsang P, Ricci M. Jiang G, et al. PDA J Pharm Sci Technol. 2013 Jul-Aug;67(4):323-35. doi: 10.5731/pdajpst.2013.00925. PDA J Pharm Sci Technol. 2013. PMID: 23872443

4

Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at -80 {degrees}C.

Zuleger B, Werner U, Kort A, Glowienka R, Wehnes E, Duncan D. Zuleger B, et al. PDA J Pharm Sci Technol. 2012 Sep-Oct;66(5):453-65. doi: 10.5731/pdajpst.2012.00884. PDA J Pharm Sci Technol. 2012. PMID: 23035029

5

Protein purification process engineering. Freeze drying: A practical overview.

Gatlin LA, Nail SL. Gatlin LA, et al. Bioprocess Technol. 1994;18:317-67. Bioprocess Technol. 1994. PMID: 7764173 Review.

6

The nonsteady state modeling of freeze drying: in-process product temperature and moisture content mapping and pharmaceutical product quality applications.

Pikal MJ, Cardon S, Bhugra C, Jameel F, Rambhatla S, Mascarenhas WJ, Akay HU. Pikal MJ, et al. Pharm Dev Technol. 2005;10(1):17-32. doi: 10.1081/pdt-35869. Pharm Dev Technol. 2005. PMID: 15776810

7

Spatial Variation of Pressure in the Lyophilization Product Chamber Part 2: Experimental Measurements and Implications for Scale-up and Batch Uniformity.

Sane P, Varma N, Ganguly A, Pikal M, Alexeenko A, Bogner RH. Sane P, et al. AAPS PharmSciTech. 2017 Feb;18(2):369-380. doi: 10.1208/s12249-016-0502-6. Epub 2016 Mar 17. AAPS PharmSciTech. 2017. PMID: 26989063

8

Determination of mass and heat transfer parameters during freeze-drying cycles of pharmaceutical products.

Hottot A, Vessot S, Andrieu J. Hottot A, et al. PDA J Pharm Sci Technol. 2005 Mar-Apr;59(2):138-53. PDA J Pharm Sci Technol. 2005. PMID: 15971546

9

Impact of Different Elastomer Formulations on Moisture Permeation through Stoppers Used for Lyophilized Products Stored under Humid Conditions.

Sasaki H, Kikuchi J, Maeda T, Kuboniwa H. Sasaki H, et al. PDA J Pharm Sci Technol. 2010 Jan-Feb;64(1):63-70. PDA J Pharm Sci Technol. 2010. PMID: 21502005

10

How Vial Geometry Variability Influences Heat Transfer and Product Temperature During Freeze-Drying.

Scutellà B, Passot S, Bourlés E, Fonseca F, Tréléa IC. Scutellà B, et al. J Pharm Sci. 2017 Mar;106(3):770-778. doi: 10.1016/j.xphs.2016.11.007. Epub 2016 Dec 8. J Pharm Sci. 2017. PMID: 27939928

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