Research ArticleResearch
A Review of Cleanroom Microflora: Types, Trends, and Patterns
Tim Sandle
PDA Journal of Pharmaceutical Science and Technology July 2011, 65 (4) 392-403; DOI: https://doi.org/10.5731/pdajpst.2011.00765
Tim Sandle

References
- 1.↵
- Akers J. E.
- 2.↵
USP—National Formulary. Chapter 〈1116〉. Microbiological Evaluation of Clean Rooms; 34th ed.; U.S. Pharmacopeial Convention: Rockville, MD, 2011.
- 3.↵
Food and Drug Administration (FDA). Guideline on Sterile Drug Products Produced by Aseptic Processing. FDA: Rockville, MD, 2004.
- 4.↵
Euradlex. The Rules Governing Medicinal Products in the European Community, Annex 1; European Commission: Brussels, 2009.
- 5.↵
- Gao Z.,
- Tseng C. H.,
- Pei Z.,
- Blaser M. J.
- 6.↵
- Costello E. K.,
- Lauber C. L.,
- Hamady M.,
- Fierer N.,
- Gordon J. I.,
- Knight R.
- 7.↵
- Grice E. A.,
- Kong H. H.,
- Renaud G.,
- Young A. C.,
- Bouffard G. G.,
- Blakesley R. W.,
- Wolfsberg T. G.,
- Turner M. L.,
- Segre J. A.
- 8.↵
- Grice E. A.,
- Kong H. H.,
- Conlan S.,
- Deming C. B.,
- Davis J.,
- Young A. C.,
- Bouffard G. G.,
- Blakesley R. W.,
- Murray P. R.,
- Green E. D.,
- Turner M. L.,
- Segre J. A.
- 9.↵
- Moissl C.,
- Osma S.,
- La Duc M. T.,
- Dekas A.,
- Brodie E.,
- DeSantis T.,
- Venkateswaran K.
- 10.↵
- 11.↵
- La Duc M. T.,
- Osman S.,
- Vaishampayan P.,
- Piceno Y.,
- Andersen G.,
- Spry J. A.,
- Venkateswaran K.
- 12.↵
- Halls N.
- Halls N.
- 13.↵
- Ackers J.,
- Carleton F.
- Haberer K.
- 14.↵
- Jiminez L.
- Jiminez L.
- 15.↵
- Whyte W.
- 16.↵
- Clarridge J.
- 17.↵
- 18.↵
- 19.↵
- 20.↵
- Hyde W.
- 21.↵
- Hodges N.,
- Hanlon G.
- Johnson S.
- 22.↵
- Heikens E.,
- Fleer A.,
- Paauw A.,
- Florijn A.,
- Fluit A. C.
- 23.↵
- La Duc M. T.,
- Dekas A.,
- Osman S.,
- Moissl M.,
- Newcombe D.,
- Venkateswaran K.
- 24.↵
- Bartnett C.,
- Polarine J.,
- Lopolito P.
- 25.↵
- Ramstorp M.,
- Gustavsson M.,
- Gudmundsson A.
- 26.↵
- 27.↵
- Ramstorp M.
- 28.↵
- 29.↵
- Forbes B. A.,
- Sahm D. F.,
- Weissfeld A. F.
- 30.↵
- Sutton S. V. W.,
- Cundell A. M.
- 31.↵
- Petti C. A.,
- Polage C. R.,
- Schreckenberger P.
- 32.↵
- Maxam A. M.,
- Gilbert W.
- 33.↵
- Tang Y. W.,
- Ellis N. M.,
- Hopkins M. K.,
- Smith D. H.,
- Dodge D. E.,
- Persing D. H.
- 34.↵
- Garrity M. G.
- 35.↵
Parenteral Drug Association Technical Report 13. Revised fundamentals of an environmental monitoring program. J. Pharm. Sci. Technol. 2001, 55, 33.
- 36.↵
- Nagarkar P. P.,
- Ravetkar S. D.,
- Watve M. G.
- 37.↵
- Kell D. B.,
- Kaprelyants A. S.,
- Weichert D. H.,
- Harwood C. R.,
- Barer M. R.
- 38.↵
- Oliver J. D.
- 39.↵
- 40.↵
- Bitkover C. Y.,
- Marcusson E.,
- Ransjo U.
- 41.↵
- Booth C.
- 42.↵
- Cundell A. M.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 65, Issue 4
July/August 2011
A Review of Cleanroom Microflora: Types, Trends, and Patterns
Tim Sandle
PDA Journal of Pharmaceutical Science and Technology Jul 2011, 65 (4) 392-403; DOI: 10.5731/pdajpst.2011.00765
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