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1

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

2

Non-volatile extractable analysis of prefilled syringes for parenteral administration of drug products.

Dorival-García N, Larsson I, Bones J. Dorival-García N, et al. J Pharm Biomed Anal. 2017 Aug 5;142:337-342. doi: 10.1016/j.jpba.2017.05.008. Epub 2017 May 5. J Pharm Biomed Anal. 2017. PMID: 28538204

3

Non-destructive vacuum decay method for pre-filled syringe closure integrity testing compared with dye ingress testing and high-voltage leak detection.

Simonetti A, Amari F. Simonetti A, et al. PDA J Pharm Sci Technol. 2015 Jan-Feb;69(1):108-22. doi: 10.5731/pdajpst.2015.01004. PDA J Pharm Sci Technol. 2015. PMID: 25691719

4

A Holistic Approach of Extractables and Leachables Assessment of Rubber Stoppered Glass Vial Systems for Biotechnology Products.

Qi L, Liu J, Ronk M, Gallegos A, Fujimori K, Luo Y, Li K, Lee H, Nashed-Samuel Y. Qi L, et al. J Pharm Sci. 2021 Nov;110(11):3580-3593. doi: 10.1016/j.xphs.2021.07.015. Epub 2021 Jul 27. J Pharm Sci. 2021. PMID: 34324943

5

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

6

A strategy for the prevention of protein oxidation by drug product in polymer-based syringes.

Nakamura K, Abe Y, Kiminami H, Yamashita A, Iwasaki K, Suzuki S, Yoshino K, Dierick W, Constable K. Nakamura K, et al. PDA J Pharm Sci Technol. 2015 Jan-Feb;69(1):88-95. doi: 10.5731/pdajpst.2015.01009. PDA J Pharm Sci Technol. 2015. PMID: 25691717

7

Recommendation of Single Time Point Leachables Testing for Lyophilized Biotechnology Products Stored in Rubber Stoppered Glass Vial Systems.

Gallegos A, Liu J, Ronk M, Qi L, Li K, Semin D, Nashed-Samuel Y. Gallegos A, et al. J Pharm Sci. 2022 Jun;111(6):1599-1604. doi: 10.1016/j.xphs.2022.03.001. Epub 2022 Mar 5. J Pharm Sci. 2022. PMID: 35257694

8

Development of an inductively coupled plasma mass spectrometry method for quantification of extracted tungsten from glass prefilled syringes used as a primary packaging for pharmaceutical and therapeutic protein products.

Fujimori K, Lee H, Phillips J, Nashed-Samuel Y. Fujimori K, et al. PDA J Pharm Sci Technol. 2013 Nov-Dec;67(6):670-9. doi: 10.5731/pdajpst.2013.00941. PDA J Pharm Sci Technol. 2013. PMID: 24265307

9

Comparison of a Lyophilized Drug Product to Other Solid and Liquid Media for the Extraction of Elastomeric Oligomers from a Butyl Rubber Stopper.

Zdravkovic SA. Zdravkovic SA. PDA J Pharm Sci Technol. 2017 Nov-Dec;71(6):488-501. doi: 10.5731/pdajpst.2016.007468. Epub 2017 Sep 19. PDA J Pharm Sci Technol. 2017. PMID: 28928293

10

Analysis of biopharmaceutical market-appropriate plastic syringe barrel for extractables.

DeGrazio F, Runkle J, Smythe J, Miller A. DeGrazio F, et al. PDA J Pharm Sci Technol. 2009 Jul-Aug;63(4):360-7. PDA J Pharm Sci Technol. 2009. PMID: 20088249

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