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1

Failure of Glass Tubing Vials during Lyophilization.

Machak DR, Smay GL. Machak DR, et al. PDA J Pharm Sci Technol. 2019 Jan-Feb;73(1):30-38. doi: 10.5731/pdajpst.2017.008276. Epub 2018 Oct 25. PDA J Pharm Sci Technol. 2019. PMID: 30361283

2

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

3

Investigating factors leading to fogging of glass vials in lyophilized drug products.

Abdul-Fattah AM, Oeschger R, Roehl H, Bauer Dauphin I, Worgull M, Kallmeyer G, Mahler HC. Abdul-Fattah AM, et al. Eur J Pharm Biopharm. 2013 Oct;85(2):314-26. doi: 10.1016/j.ejpb.2013.06.007. Epub 2013 Jun 19. Eur J Pharm Biopharm. 2013. PMID: 23791681

4

Method to Predict Glass Vial Fogging in Lyophilized Drug Products.

Langer C, Mahler HC, Koulov A, Marti N, Grigore C, Matter A, Chalus P, Singh S, Lemazurier T, Joerg S, Mathaes R. Langer C, et al. J Pharm Sci. 2020 Jan;109(1):323-330. doi: 10.1016/j.xphs.2019.08.024. Epub 2019 Aug 29. J Pharm Sci. 2020. PMID: 31473212

5

Fundamentals of freeze-drying.

Nail SL, Jiang S, Chongprasert S, Knopp SA. Nail SL, et al. Pharm Biotechnol. 2002;14:281-360. doi: 10.1007/978-1-4615-0549-5_6. Pharm Biotechnol. 2002. PMID: 12189727 Review.

6

Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation.

Nieto A, Roehl H, Adler M, Mohl S. Nieto A, et al. PDA J Pharm Sci Technol. 2018 Nov-Dec;72(6):544-552. doi: 10.5731/pdajpst.2017.008383. Epub 2018 May 31. PDA J Pharm Sci Technol. 2018. PMID: 29853608

7

Mechanistic studies of glass vial breakage for frozen formulations. I. Vial breakage caused by crystallizable excipient mannitol.

Jiang G, Akers M, Jain M, Guo J, Distler A, Swift R, Wadhwa MV, Jameel F, Patro S, Freund E. Jiang G, et al. PDA J Pharm Sci Technol. 2007 Nov-Dec;61(6):441-51. PDA J Pharm Sci Technol. 2007. PMID: 18410045

8

Comparative Leachable Study of Glass Vials to Demonstrate the Impact of Low Fill Volume.

Hladik B, Buscke F, Frost R, Rothhaar U. Hladik B, et al. PDA J Pharm Sci Technol. 2019 Jul-Aug;73(4):345-355. doi: 10.5731/pdajpst.2018.009472. Epub 2019 Feb 15. PDA J Pharm Sci Technol. 2019. PMID: 30770482

9

The effect of loading process on product collapse during large-scale lyophilization.

Wallen AJ, Van Ocker SH, Sinacola JR, Phillips BR. Wallen AJ, et al. J Pharm Sci. 2009 Mar;98(3):997-1004. doi: 10.1002/jps.21491. J Pharm Sci. 2009. PMID: 18661543

10

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

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