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1

Introducing the Alba® Primary Packaging Platform. Part 2: Inorganic Extractables Evaluation.

Chillon A, Zuccato D. Chillon A, et al. PDA J Pharm Sci Technol. 2019 May-Jun;73(3):235-246. doi: 10.5731/pdajpst.2018.009423. Epub 2019 Jan 16. PDA J Pharm Sci Technol. 2019. PMID: 30651335

2

Introducing the Alba^® Primary Packaging Platform. Part 1: Particle Release Evaluation.

Chillon A, Pace A, Zuccato D. Chillon A, et al. PDA J Pharm Sci Technol. 2018 Jul-Aug;72(4):382-392. doi: 10.5731/pdajpst.2018.008623. Epub 2018 May 31. PDA J Pharm Sci Technol. 2018. PMID: 29853611

3

Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products.

Jenke D, Egert T, Hendricker A, Castner J, Feinberg T, Houston C, Hunt DG, Lynch M, Nicholas K, Norwood DL, Paskiet D, Ruberto M, Smith EJ, Holcomb F, Markovic I. Jenke D, et al. PDA J Pharm Sci Technol. 2017 Mar-Apr;71(2):68-87. doi: 10.5731/pdajpst.2016.007229. Epub 2016 Dec 14. PDA J Pharm Sci Technol. 2017. PMID: 27974627

4

Low Leachable Container System Consisting of a Polymer-Based Syringe with Chlorinated Isoprene Isobutene Rubber Plunger Stopper.

Kiminami H, Takeuchi K, Nakamura K, Abe Y, Lauwers P, Dierick W, Yoshino K, Suzuki S. Kiminami H, et al. PDA J Pharm Sci Technol. 2015 Nov-Dec;69(6):713-24. doi: 10.5731/pdajpst.2015.01080. PDA J Pharm Sci Technol. 2015. PMID: 26659102

5

Extractables Screening of Polypropylene Resins Used in Pharmaceutical Packaging for Safety Hazards.

Jenke D. Jenke D. PDA J Pharm Sci Technol. 2017 Sep-Oct;71(5):346-367. doi: 10.5731/pdajpst.2016.007401. Epub 2017 May 15. PDA J Pharm Sci Technol. 2017. PMID: 28512176

6

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

7

Enhancing Patient Safety through the Use of a Pharmaceutical Glass Designed To Prevent Cracked Containers.

Schaut RA, Hoff KC, Demartino SE, Denson WK, Verkleeren RL. Schaut RA, et al. PDA J Pharm Sci Technol. 2017 Nov-Dec;71(6):511-528. doi: 10.5731/pdajpst.2017.007807. Epub 2017 Sep 19. PDA J Pharm Sci Technol. 2017. PMID: 28928290

8

Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products.

Li K, Rogers G, Nashed-Samuel Y, Lee H, Mire-Sluis A, Cherney B, Forster R, Yeh P, Markovic I. Li K, et al. PDA J Pharm Sci Technol. 2015 Sep-Oct;69(5):590-619. doi: 10.5731/pdajpst.2015.01073. PDA J Pharm Sci Technol. 2015. PMID: 26429108

9

A new glass option for parenteral packaging.

Schaut RA, Peanasky JS, DeMartino SE, Schiefelbein SL. Schaut RA, et al. PDA J Pharm Sci Technol. 2014 Sep-Oct;68(5):527-34. doi: 10.5731/pdajpst.2014.00998. PDA J Pharm Sci Technol. 2014. PMID: 25336422

10

Inhibiting Sterilization-Induced Oxidation of Large Molecule Therapeutics Packaged in Plastic Parenteral Vials.

Vieregg JR, Martin SJ, Breeland AP, Weikart CM, Tirrell MV. Vieregg JR, et al. PDA J Pharm Sci Technol. 2018 Jan-Feb;72(1):35-43. doi: 10.5731/pdajpst.2017.008011. Epub 2017 Sep 19. PDA J Pharm Sci Technol. 2018. PMID: 28928291

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