Data Mining to Determine the Influence of Fluid Properties on the Integrity Test Values

References

1. 1.↵
   European Commission, EudraLex—The Rules Governing Medicinal Products in the European Union, Volume 4: Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use: Annex 1: Manufacture of Sterile Medicinal Products, Commission Directive 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC. European Commission: Brussels.
2. 2.↵
   1. Antonsen H. R.,
   2. Awafo V.,
   3. Bender J. L.,
   4. Carter J.R.,
   5. Conway R. S.,
   6. Egli S.,
   7. Feeser T. M.,
   8. Jornitz M. W.,
   9. Kearns M.,
   10. Levy R. V,
   11. Madsen R. E.,
   12. Martin J. M.,
   13. McBurnie L. D.,
   14. Meissner L. S.,
   15. Meltzer T. H.,
   16. Pawar V.,
   17. Phelan M.,
   18. Stinavage P. S.,
   19. Sweeney N.,
   20. Vega H.,
   21. Witchey-Lakshmanan L. C.

   ; Sterilizing Filtration of Liquids Task Force. Sterilizing Filtration of Liquids. Technical Report No. 26 (Revised 2008). PDA J. Pharm. Sci. Technol. 2008, 62 (5 Suppl TR26),2–60.

   OpenUrlPubMed
3. 3.↵
   1. Belgaid A.,
   2. Benaji B.,
   3. Aadil N.,
   4. Moussamih S.,
   5. Khayati Y.,
   6. Taoudi Benchekroune M.,
   7. El Guezzar M.

   Sterilisation of Aseptic Drug by Sterile Filtration: Microbiology Validation by Microbiology Challenge Test. J. Chem. Pharm. Res. 2014, 6 (12), 760–770.

   OpenUrl
4. 4.↵
   1. McBurnie L.,
   2. Bardo B.

   Validation of Sterile Filtration. Pharm. Technol. 2004, (7, Suppl.), S13–S23.
5. 5.↵
   1. Osumi M.,
   2. Yamada N.,
   3. Toya M.

   Bacterial Retention Mechanisms of Membrane Filters. PDA J. Pharm. Sci. Technol. 1996, 50 (1), 30–34.

   OpenUrlFREE Full Text
6. 6.↵
   1. Pall D. P.,
   2. Kirnbauer E. A.

   Bacterial Removal Prediction in Membrane Filters, Presented at the 52nd Colloid & Surface Science Symposium, Knoxville, TN, June 12, 1978.
7. 7.↵
   Design, Control, and Monitoring of Single-Use Systems for Integrity Assurance. Bio-Process Systems Alliance Web site. http://www.bpsalliance.org/technical-guides/ (accessed Sep 27, 2019).
8. 8.↵
   1. Sharma A.

   Filter Clogging Issues in Sterile Filtration. BioPharm. Int. [Online] 2008, 21 (4), http://www.biopharminternational.com/filter-clogging-issues-sterile-filtration (accessed July 22, 2019).