Similar articles for PMID: 34845101

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1

Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality.

McDonnell G, Baseman H, Cordie-Bancroft L. McDonnell G, et al. PDA J Pharm Sci Technol. 2021 Nov-Dec;75(6):553-570. doi: 10.5731/pdajpst.2021.012706. PDA J Pharm Sci Technol. 2021. PMID: 34845101

2

Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality.

McDonnell G, Baseman H, Cordie-Bancroft L. McDonnell G, et al. Biomed Instrum Technol. 2021 Nov 1;55(4):143-164. doi: 10.2345/0890-8205-55.4.143. Biomed Instrum Technol. 2021. PMID: 34727572

3

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

4

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

5

The limits of sterility assurance.

von Woedtke T, Kramer A. von Woedtke T, et al. GMS Krankenhhyg Interdiszip. 2008 Sep 3;3(3):Doc19. GMS Krankenhhyg Interdiszip. 2008. PMID: 20204091 Free PMC article.

6

A Bayesian Approach to Determination of F, D, and Z Values Used in Steam Sterilization Validation.

Faya P, Stamey JD, Seaman JW Jr. Faya P, et al. PDA J Pharm Sci Technol. 2017 Mar-Apr;71(2):88-98. doi: 10.5731/pdajpst.2016.006981. Epub 2016 Oct 27. PDA J Pharm Sci Technol. 2017. PMID: 27789802

7

[Hygienic precautions and microbiological quality control during the manufacturing of sterile drugs].

Züge R. Züge R. Zentralbl Bakteriol Mikrobiol Hyg B. 1982 May;176(2-3):134-41. Zentralbl Bakteriol Mikrobiol Hyg B. 1982. PMID: 7124163 German.

8

Container Closure Integrity Testing-Practical Aspects and Approaches in the Pharmaceutical Industry.

Brown H, Mahler HC, Mellman J, Nieto A, Wagner D, Schaar M, Mathaes R, Kossinna J, Schmitting F, Dreher S, Roehl H, Hemminger M, Wuchner K. Brown H, et al. PDA J Pharm Sci Technol. 2017 Mar-Apr;71(2):147-162. doi: 10.5731/pdajpst.2016.006999. Epub 2016 Oct 27. PDA J Pharm Sci Technol. 2017. PMID: 27789803

9

Radiation and ethylene oxide terminal sterilization experiences with drug eluting stent products.

Lambert BJ, Mendelson TA, Craven MD. Lambert BJ, et al. AAPS PharmSciTech. 2011 Dec;12(4):1116-26. doi: 10.1208/s12249-011-9644-8. Epub 2011 Sep 2. AAPS PharmSciTech. 2011. PMID: 21887604 Free PMC article. Review.

10

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

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