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1

Justification for the use of aseptic filling for sterile injectable products.

Cundell AM. Cundell AM. PDA J Pharm Sci Technol. 2014 Jul-Aug;68(4):323-32. doi: 10.5731/pdajpst.2014.00988. PDA J Pharm Sci Technol. 2014. PMID: 25035255

2

Increasing Patient Safety by Closing the Sterile Production Gap-Part 3-Moist Heat Resistance of Bioburden.

Agalloco JP. Agalloco JP. PDA J Pharm Sci Technol. 2017 Jul-Aug;71(4):274-278. doi: 10.5731/pdajpst.2017.007641. Epub 2017 Apr 17. PDA J Pharm Sci Technol. 2017. PMID: 28416646 Review.

3

Increasing Patient Safety by Closing the Sterile Production Gap-Part 2. Implementation.

Agalloco JP. Agalloco JP. PDA J Pharm Sci Technol. 2017 Jul-Aug;71(4):269-273. doi: 10.5731/pdajpst.2016.007112. Epub 2017 Jan 15. PDA J Pharm Sci Technol. 2017. PMID: 28089965 Review.

4

Implementing AORN recommended practices for selection and use of packaging systems for sterilization.

Morton PJ, Conner R. Morton PJ, et al. AORN J. 2014 Apr;99(4):495-502; quiz 502-5. doi: 10.1016/j.aorn.2014.02.014. AORN J. 2014. PMID: 24674795

5

Product Sterility Testing . . . To Test or Not to Test? That Is the Question.

Daniell E, Bryans T, Darnell K, Hansen J, Hitchins VM, Saavedra M. Daniell E, et al. Biomed Instrum Technol. 2016 Apr 2;50 Suppl 3:35-43. doi: 10.2345/0899-8205-50.s3.35. Biomed Instrum Technol. 2016. PMID: 27100074

6

Quality comparison of continuous steam sterilization segmented-flow aseptic processing versus conventional canning of whole and sliced mushrooms.

Anderson NM, Walker PN. Anderson NM, et al. J Food Sci. 2011 Aug;76(6):E429-37. doi: 10.1111/j.1750-3841.2011.02221.x. Epub 2011 Jun 2. J Food Sci. 2011. PMID: 22417494

7

Increasing Patient Safety by Closing the Sterile Production Gap-Part 1. Introduction.

Agalloco JP. Agalloco JP. PDA J Pharm Sci Technol. 2017 Jul-Aug;71(4):261-268. doi: 10.5731/pdajpst.2016.007104. Epub 2017 Jan 15. PDA J Pharm Sci Technol. 2017. PMID: 28089964 Review.

8

A QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016.

Santos AMC, Doria MS, Meirinhos-Soares L, Almeida AJ, Menezes JC. Santos AMC, et al. PDA J Pharm Sci Technol. 2018 Jan-Feb;72(1):62-72. doi: 10.5731/pdajpst.2016.007252. Epub 2017 Dec 14. PDA J Pharm Sci Technol. 2018. PMID: 29242394

9

[Study of the deadlines for the use after sterilization of hot-sealable bags and sheaths].

Leguay Z, Figueiredo E, Evrillus L, Jacques-Terracol V, Le Verger M. Leguay Z, et al. Ann Pharm Fr. 2018 Jul;76(4):321-333. doi: 10.1016/j.pharma.2018.01.003. Epub 2018 Feb 23. Ann Pharm Fr. 2018. PMID: 29478716 French.

10

Gamma sterilization of pharmaceuticals--a review of the irradiation of excipients, active pharmaceutical ingredients, and final drug product formulations.

Hasanain F, Guenther K, Mullett WM, Craven E. Hasanain F, et al. PDA J Pharm Sci Technol. 2014 Mar-Apr;68(2):113-37. doi: 10.5731/pdajpst.2014.00955. PDA J Pharm Sci Technol. 2014. PMID: 24668600 Review.

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