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1

Critical influences of particles, pores, and prefilters in sterilizing filtration.

Madsen RE, Meltzer TH. Madsen RE, et al. PDA J Pharm Sci Technol. 2009 May-Jun;63(3):240-4. PDA J Pharm Sci Technol. 2009. PMID: 20069797

2

Sterilizing filtration of liquids. Technical report no. 26 (revised 2008).

Antonsen HR, Awafo V, Bender JL, Carter JR, Conway RS, Egli S, Feeser TM, Jornitz MW, Kearns M, Levy RV, Madsen RE, Martin JM, McBurnie LD, Meissner LS, Meltzer TH, Pawar V, Phelan M, Stinavage PS, Sweeney N, Vega H, Witchey-Lakshmanan LC; Sterilizing Filtration of Liquids Task Force. Antonsen HR, et al. PDA J Pharm Sci Technol. 2008;62(5 Suppl TR26):2-60. PDA J Pharm Sci Technol. 2008. PMID: 19642423 No abstract available.

3

Effects of sterilizing-grade filters on the physico-chemical properties of onion-like vesicles.

Richard A, Delvaux J, Bourel-Bonnet L. Richard A, et al. Int J Pharm. 2006 Apr 7;312(1-2):144-50. doi: 10.1016/j.ijpharm.2006.01.007. Epub 2006 Feb 15. Int J Pharm. 2006. PMID: 16480839

4

Validation of sterilizing grade filtration.

Jornitz MW, Meltzer TH. Jornitz MW, et al. Dev Biol (Basel). 2003;113:65-9. Dev Biol (Basel). 2003. PMID: 14620854

5

Sterile Filtration.

Akers MJ. Akers MJ. Int J Pharm Compd. 2015 Sep-Oct;19(5):393-401. Int J Pharm Compd. 2015. PMID: 26775447

6

Use of pressure-hold test for sterilizing filter membrane integrity in radiopharmaceutical manufacturing.

Belanger AP, Byrne JF, Paolino JM, DeGrado TR. Belanger AP, et al. Nucl Med Biol. 2009 Nov;36(8):955-9. doi: 10.1016/j.nucmedbio.2009.07.008. Nucl Med Biol. 2009. PMID: 19875052

7

Prefilters/final filters: a matter of particle/pore size-distributions.

Lukaszewicz RC, Johnston PR, Meltzer TH. Lukaszewicz RC, et al. J Parenter Sci Technol. 1981 Jan-Feb;35(1):40-7. J Parenter Sci Technol. 1981. PMID: 7229830 No abstract available.

8

Scalability of Sterilizing-Grade Filters in Different Filtration Modes.

Jannik D, Sebastian H, BjÖrn H, Thomas L. Jannik D, et al. PDA J Pharm Sci Technol. 2020 Nov-Dec;74(6):644-659. doi: 10.5731/pdajpst.2019.011254. Epub 2020 Jul 16. PDA J Pharm Sci Technol. 2020. PMID: 32675307

9

Preuse/Poststerilization Integrity Testing (PUPSIT): To Do or Not to Do?

Gupta VS, Jindal J, Gupta A, Gupta NK. Gupta VS, et al. PDA J Pharm Sci Technol. 2020 May-Jun;74(3):301-308. doi: 10.5731/pdajpst.2018.009449. Epub 2019 Nov 15. PDA J Pharm Sci Technol. 2020. PMID: 31732690

10

Sterilizing filtration of gases. Technical report no. 40. Parenteral Drug Association.

PDA International Association for Pharmaceutical Science and Technology. PDA International Association for Pharmaceutical Science and Technology. PDA J Pharm Sci Technol. 2005 Jan-Feb;58(1 Suppl TR40):7-44. PDA J Pharm Sci Technol. 2005. PMID: 16459440 No abstract available.

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