The Importance of Accurate Microorganism Identification in Microbial Challenge Tests of Membrane Filters—Part I

I. Kaesler; G. Haake; H. Hennig; A. Rosenhagen; T. H. Meltzer; M. W. Jornitz

References

1.↵
American Society for Testing and Materials (ASTM), Standard F838-05, Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration; ASTM International: West Conshohocken, PA, 2005.
2.↵
U.S. Food and Drug Administration (FDA). Guidance for industry: sterile drug products produced by aseptic processing; Center for Drugs and Biologics and Office of Regulatory Affairs; Food and Drug Administration: Rockville, MD, 2004.
3.↵
Sterilizing filtration of liquids. Technical report no. 26. PDA J. Pharm. Sci. Technol. 2008, 52 (S1).
4.↵
1. Sundaram S.,
2. Auriemma M.,
3. Howard G. Jr..,
4. Brandwein H.,
5. Leo F.
An application of membrane filtration for removal of diminutive bioburden organisms in pharma products and processes. PDA J. Pharm. Sci. Technol. 1999, 53 (4), 186–201.
OpenUrl Abstract/FREE Full Text
5.↵
1. Sundaram S.,
2. Eisenhuth J.,
3. Howard G. Jr..,
4. Brandwein H.
Method for qualifying microbial removal performance of 0.1 micron rated filters. Part I: characterization of water isolates for potential use as standard challenge organisms to qualify 0.1 micron rated filters. PDA J. Pharm. Sci. Technol. 2001, 55 (6), 346–372.
OpenUrl Abstract/FREE Full Text
6.↵
1. Sundaram S.,
2. Eisenhuth J.,
3. Steves M.,
4. Howard G. Jr..,
5. Brandwein H.
Method for qualifying microbial removal performance of 0.1 micron rated filters. Part II: preliminary characterization of Hydrogenophaga (formerly Pseudomonas) pseudoflava for use as a standard challenge organism to qualify 0.1 micron rated filters. PDA J. Pharm. Sci. Technol. 2001, 55 (6), 373–392.
OpenUrl Abstract/FREE Full Text
7.↵
1. Sundaram S.,
2. Eisenhuth J.,
3. Lewis M.,
4. Howard G. H. Jr..,
5. Brandwein H.
Method for qualifying microbial removal performance of 0.1 micron rated filters. Part III: bacterial challenge tests on 0.2/0.22 and 0.1 micron rated filter cartridges with Hydrogenophaga (formerly Pseudomonas) pseudoflava. PDA J. Pharm. Sci. Technol. 2001, 55 (6), 393–416.
OpenUrl Abstract/FREE Full Text
8.↵
1. Sundaram S.,
2. Lewis M.,
3. Eisenhuth J.,
4. Howard G. Jr..,
5. Larson B.
Method for qualifying microbial removal performance of 0.1 micron rated filters. Part IV: retention of Hydrogenophaga pseudoflava (ATCC 700892) and Ralstonia pickettii (700591) by 0.2 and 0.22 micron rated filters. PDA J. Pharm. Sci. Technol. 2002, 56 (3), 150–171.
OpenUrl Abstract/FREE Full Text
9.↵
1. Lee A.,
2. Hussong D.,
3. Brorson K.
Filter retention studies with Hydrogenophaga pseudoflava. PDA/FDA Conference, Washington, DC, 2008.
10.↵
1. Lee A.,
2. McVey J.,
3. Faustino S.,
4. Lute S.,
5. Sweeney N.,
6. Pawar V.,
7. Khan M.,
8. Brorson K.,
9. Hussong D.
Use of Hydrogenophaga pseudoflava penetration to quantitatively assess the impact of filtration parameters for 0.2-micrometer-pore-size filters. App. Environ. Microbiol. 2010, 76 (3), 695–700.
OpenUrl Abstract/FREE Full Text
11.↵
1. Benson D. A.,
2. Karsch-Mizrachi I.,
3. Lipman D. J.,
4. Ostell J.,
5. Wheeler D. L.
GenBank. Nucleic Acids Res. 2008, 36 (Database issue), D25–D30.
OpenUrl Abstract/FREE Full Text
12.↵
1. Ludwig W.,
2. Strunk O.,
3. Westram R.,
4. Richter L.,
5. Meier H.,
6. Yadhukumar,
7. Buchner A.,
8. Lai T.,
9. Steppi S.,
10. Jobb G.,
11. Förster W.,
12. Brettske I.,
13. Gerber S.,
14. Ginhart A. W.,
15. Gross O.,
16. Grumann S.,
17. Hermann S.,
18. Jost R.,
19. König A.,
20. Liss T.,
21. Lümann R.,
22. May M.,
23. Nonhoff B.,
24. Reichel B.,
25. Strehlow R.,
26. Stamatakis A.,
27. Stuckmann N.,
28. Vilbig A.,
29. Lenke M.,
30. Ludwig T.,
31. Bode A.,
32. Schleifer K.-H.
ARB: a software environment for sequence data. Nucleic Acids Res. 2004, 32 (4), 1363–1371.
OpenUrl Abstract/FREE Full Text
13.↵
1. Pruesse E.,
2. Quast C.,
3. Knittel K.,
4. Fuchs B.,
5. Ludwig W.,
6. Peplies J.,
7. Glöckner F. O.
SILVA: a comprehensive online resource for quality checked and aligned ribosomal RNA sequence data compatible with ARB. Nucleic Acids Res. 2007, 35 (21), 7188–7196.
OpenUrl Abstract/FREE Full Text
14.↵
1. Madsen R. E.,
2. Akers J. E.,
3. Jornitz M. W.,
4. Meltzer T. H.
The use of model organisms in sterilizing filtration. Pharm. Technol. 2006, Supplement, s38–s42.
15.↵
1. Ridgway H. F.,
2. Rigby M. G.,
3. Argo D. G.
Adhesion of a mycobacterium sp. to cellulose diacetate membranes used in reverse osmosis. Appl. Environ. Microbiol. 1984, 47 (1), 61–67.
OpenUrl Abstract/FREE Full Text
16.↵
1. Tolliver D. L.,
2. Schroeder H. G.
Particle control in semiconductor process streams. Microcontamination 1983, l (l), 34–43, 78.
OpenUrl
17.↵
1. Meltzer T. H.,
2. Jornitz M. W.
Eds. Chapter 21 Mechanism of Particle Retention. Pharmaceutical Filtration: The Management of Organism Retention; PDA/DHI Publishers: Bethesda, MD, 2006.
18.↵
1. Mittelman M. W.,
2. Kawamura K.,
3. Jornitz M. W.,
4. Meltzer T. H.
Filter validation: bacterial hydrophobicity, adsorptive sequestration and cell size alteration. PDA J. Pharm. Sci. Technol. 2001, 55 (6), 422–428.
OpenUrl FREE Full Text
19.↵
Validation of microbial retention of sterilizing filters. PDA/FDA Special Scientific Forum, Bethesda, MD, 1995.
20.↵
1. Leahy T. J.,
2. Sullivan M. J.
Validation of bacterial retention capabilities of membrane filters. Pharm. Technol. 1978, 2 (11), 64–75.
OpenUrl
21.↵
1. Ding L.,
2. Yokota A.
Proposals of Curvibacter gracilis gen. nov., sp. nov. and Herbaspirillum putei sp. nov. for bacterial strains isolated from well water and reclassification of [Pseudomonas] huttiensis, [Pseudomonas] lanceolata, [Aquaspirillum] delicatum and [Aquaspirillum] autotrophicum as Herbaspirillum huttiense comb. nov., Curvibacter lanceolatus comb. nov., Curvibacter delicatus comb. nov., and Herbaspirillum autotrophicum comb. nov. Int. J. Syst. Evol. Microbiol. 2004, 54 (Pt. 6), 2223–2230.
OpenUrl Abstract/FREE Full Text
22.
1. Leifson E.
The bacterial flora of distilled and stored water. III. New species of the genera Corynebacterium, Flavobacterium, Spirillum and Pseudomonas. Int. Bull. Bacteriol. Nomencl. Taxon. 1962, 12, 161–170.
OpenUrl CrossRef
23.
1. Hylemon P. B.,
2. Wells J. S. Jr..,
3. Krieg N. R.,
4. Jannasch H.
W. The genus Spirillum: a taxonomic study. Int. J. Syst. Bacteriol. 1973, 23, 340–380.
OpenUrl Abstract/FREE Full Text
24.
1. Garrity G.
1. Vancanneyt M.,
2. Segers P.,
3. Abraham W.,
4. De Vos P.
Brevundimonas. In Bergey's Manual of Systematic Bacteriology; Garrity G. Ed.; Springer: New York, 2009; Vol. 2, Part C, pp 308–316.
OpenUrl
25.
1. Garrity G.
1. Willems A.,
2. Gillis M.
Hydrogenophaga. In Bergey's Manual of Systematic Bacteriology; Garrity G. Ed.; Springer: New York, 2009; Vol. 2, Part C.

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[1] 1.↵
American Society for Testing and Materials (ASTM), Standard F838-05, Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration; ASTM International: West Conshohocken, PA, 2005.

[2] 2.↵
U.S. Food and Drug Administration (FDA). Guidance for industry: sterile drug products produced by aseptic processing; Center for Drugs and Biologics and Office of Regulatory Affairs; Food and Drug Administration: Rockville, MD, 2004.

[3] 3.↵
Sterilizing filtration of liquids. Technical report no. 26. PDA J. Pharm. Sci. Technol. 2008, 52 (S1).

[4] 4.↵
Sundaram S.,
Auriemma M.,
Howard G. Jr..,
Brandwein H.,
Leo F.
An application of membrane filtration for removal of diminutive bioburden organisms in pharma products and processes. PDA J. Pharm. Sci. Technol. 1999, 53 (4), 186–201.
OpenUrl Abstract/FREE Full Text

[5] Sundaram S.,

[6] Auriemma M.,

[7] Howard G. Jr..,

[8] Brandwein H.,

[9] Leo F.

[10] 5.↵
Sundaram S.,
Eisenhuth J.,
Howard G. Jr..,
Brandwein H.
Method for qualifying microbial removal performance of 0.1 micron rated filters. Part I: characterization of water isolates for potential use as standard challenge organisms to qualify 0.1 micron rated filters. PDA J. Pharm. Sci. Technol. 2001, 55 (6), 346–372.
OpenUrl Abstract/FREE Full Text

[11] Sundaram S.,

[12] Eisenhuth J.,

[13] Howard G. Jr..,

[14] Brandwein H.

[15] 6.↵
Sundaram S.,
Eisenhuth J.,
Steves M.,
Howard G. Jr..,
Brandwein H.
Method for qualifying microbial removal performance of 0.1 micron rated filters. Part II: preliminary characterization of Hydrogenophaga (formerly Pseudomonas) pseudoflava for use as a standard challenge organism to qualify 0.1 micron rated filters. PDA J. Pharm. Sci. Technol. 2001, 55 (6), 373–392.
OpenUrl Abstract/FREE Full Text

[16] Sundaram S.,

[17] Eisenhuth J.,

[18] Steves M.,

[19] Howard G. Jr..,

[20] Brandwein H.

[21] 7.↵
Sundaram S.,
Eisenhuth J.,
Lewis M.,
Howard G. H. Jr..,
Brandwein H.
Method for qualifying microbial removal performance of 0.1 micron rated filters. Part III: bacterial challenge tests on 0.2/0.22 and 0.1 micron rated filter cartridges with Hydrogenophaga (formerly Pseudomonas) pseudoflava. PDA J. Pharm. Sci. Technol. 2001, 55 (6), 393–416.
OpenUrl Abstract/FREE Full Text

[22] Sundaram S.,

[23] Eisenhuth J.,

[24] Lewis M.,

[25] Howard G. H. Jr..,

[26] Brandwein H.

[27] 8.↵
Sundaram S.,
Lewis M.,
Eisenhuth J.,
Howard G. Jr..,
Larson B.
Method for qualifying microbial removal performance of 0.1 micron rated filters. Part IV: retention of Hydrogenophaga pseudoflava (ATCC 700892) and Ralstonia pickettii (700591) by 0.2 and 0.22 micron rated filters. PDA J. Pharm. Sci. Technol. 2002, 56 (3), 150–171.
OpenUrl Abstract/FREE Full Text

[28] Sundaram S.,

[29] Lewis M.,

[30] Eisenhuth J.,

[31] Howard G. Jr..,

[32] Larson B.

[33] 9.↵
Lee A.,
Hussong D.,
Brorson K.
Filter retention studies with Hydrogenophaga pseudoflava. PDA/FDA Conference, Washington, DC, 2008.

[34] Lee A.,

[35] Hussong D.,

[36] Brorson K.

[37] 10.↵
Lee A.,
McVey J.,
Faustino S.,
Lute S.,
Sweeney N.,
Pawar V.,
Khan M.,
Brorson K.,
Hussong D.
Use of Hydrogenophaga pseudoflava penetration to quantitatively assess the impact of filtration parameters for 0.2-micrometer-pore-size filters. App. Environ. Microbiol. 2010, 76 (3), 695–700.
OpenUrl Abstract/FREE Full Text

[38] Lee A.,

[39] McVey J.,

[40] Faustino S.,

[41] Lute S.,

[42] Sweeney N.,

[43] Pawar V.,

[44] Khan M.,

[45] Brorson K.,

[46] Hussong D.

[47] 11.↵
Benson D. A.,
Karsch-Mizrachi I.,
Lipman D. J.,
Ostell J.,
Wheeler D. L.
GenBank. Nucleic Acids Res. 2008, 36 (Database issue), D25–D30.
OpenUrl Abstract/FREE Full Text

[48] Benson D. A.,

[49] Karsch-Mizrachi I.,

[50] Lipman D. J.,

[51] Ostell J.,

[52] Wheeler D. L.

[53] 12.↵
Ludwig W.,
Strunk O.,
Westram R.,
Richter L.,
Meier H.,
Yadhukumar,
Buchner A.,
Lai T.,
Steppi S.,
Jobb G.,
Förster W.,
Brettske I.,
Gerber S.,
Ginhart A. W.,
Gross O.,
Grumann S.,
Hermann S.,
Jost R.,
König A.,
Liss T.,
Lümann R.,
May M.,
Nonhoff B.,
Reichel B.,
Strehlow R.,
Stamatakis A.,
Stuckmann N.,
Vilbig A.,
Lenke M.,
Ludwig T.,
Bode A.,
Schleifer K.-H.
ARB: a software environment for sequence data. Nucleic Acids Res. 2004, 32 (4), 1363–1371.
OpenUrl Abstract/FREE Full Text

[54] Ludwig W.,

[55] Strunk O.,

[56] Westram R.,

[57] Richter L.,

[58] Meier H.,

[59] Yadhukumar,

[60] Buchner A.,

[61] Lai T.,

[62] Steppi S.,

[63] Jobb G.,

[64] Förster W.,

[65] Brettske I.,

[66] Gerber S.,

[67] Ginhart A. W.,

[68] Gross O.,

[69] Grumann S.,

[70] Hermann S.,

[71] Jost R.,

[72] König A.,

[73] Liss T.,

[74] Lümann R.,

[75] May M.,

[76] Nonhoff B.,

[77] Reichel B.,

[78] Strehlow R.,

[79] Stamatakis A.,

[80] Stuckmann N.,

[81] Vilbig A.,

[82] Lenke M.,

[83] Ludwig T.,

[84] Bode A.,

[85] Schleifer K.-H.

[86] 13.↵
Pruesse E.,
Quast C.,
Knittel K.,
Fuchs B.,
Ludwig W.,
Peplies J.,
Glöckner F. O.
SILVA: a comprehensive online resource for quality checked and aligned ribosomal RNA sequence data compatible with ARB. Nucleic Acids Res. 2007, 35 (21), 7188–7196.
OpenUrl Abstract/FREE Full Text

[87] Pruesse E.,

[88] Quast C.,

[89] Knittel K.,

[90] Fuchs B.,

[91] Ludwig W.,

[92] Peplies J.,

[93] Glöckner F. O.

[94] 14.↵
Madsen R. E.,
Akers J. E.,
Jornitz M. W.,
Meltzer T. H.
The use of model organisms in sterilizing filtration. Pharm. Technol. 2006, Supplement, s38–s42.

[95] Madsen R. E.,

[96] Akers J. E.,

[97] Jornitz M. W.,

[98] Meltzer T. H.

[99] 15.↵
Ridgway H. F.,
Rigby M. G.,
Argo D. G.
Adhesion of a mycobacterium sp. to cellulose diacetate membranes used in reverse osmosis. Appl. Environ. Microbiol. 1984, 47 (1), 61–67.
OpenUrl Abstract/FREE Full Text

[100] Ridgway H. F.,

[101] Rigby M. G.,

[102] Argo D. G.

[103] 16.↵
Tolliver D. L.,
Schroeder H. G.
Particle control in semiconductor process streams. Microcontamination 1983, l (l), 34–43, 78.
OpenUrl

[104] Tolliver D. L.,

[105] Schroeder H. G.

[106] 17.↵
Meltzer T. H.,
Jornitz M. W.
Eds. Chapter 21 Mechanism of Particle Retention. Pharmaceutical Filtration: The Management of Organism Retention; PDA/DHI Publishers: Bethesda, MD, 2006.

[107] Meltzer T. H.,

[108] Jornitz M. W.

[109] 18.↵
Mittelman M. W.,
Kawamura K.,
Jornitz M. W.,
Meltzer T. H.
Filter validation: bacterial hydrophobicity, adsorptive sequestration and cell size alteration. PDA J. Pharm. Sci. Technol. 2001, 55 (6), 422–428.
OpenUrl FREE Full Text

[110] Mittelman M. W.,

[111] Kawamura K.,

[112] Jornitz M. W.,

[113] Meltzer T. H.

[114] 19.↵
Validation of microbial retention of sterilizing filters. PDA/FDA Special Scientific Forum, Bethesda, MD, 1995.

[115] 20.↵
Leahy T. J.,
Sullivan M. J.
Validation of bacterial retention capabilities of membrane filters. Pharm. Technol. 1978, 2 (11), 64–75.
OpenUrl

[116] Leahy T. J.,

[117] Sullivan M. J.

[118] 21.↵
Ding L.,
Yokota A.
Proposals of Curvibacter gracilis gen. nov., sp. nov. and Herbaspirillum putei sp. nov. for bacterial strains isolated from well water and reclassification of [Pseudomonas] huttiensis, [Pseudomonas] lanceolata, [Aquaspirillum] delicatum and [Aquaspirillum] autotrophicum as Herbaspirillum huttiense comb. nov., Curvibacter lanceolatus comb. nov., Curvibacter delicatus comb. nov., and Herbaspirillum autotrophicum comb. nov. Int. J. Syst. Evol. Microbiol. 2004, 54 (Pt. 6), 2223–2230.
OpenUrl Abstract/FREE Full Text

[119] Ding L.,

[120] Yokota A.

[121] 22.
Leifson E.
The bacterial flora of distilled and stored water. III. New species of the genera Corynebacterium, Flavobacterium, Spirillum and Pseudomonas. Int. Bull. Bacteriol. Nomencl. Taxon. 1962, 12, 161–170.
OpenUrl CrossRef

[122] Leifson E.

[123] 23.
Hylemon P. B.,
Wells J. S. Jr..,
Krieg N. R.,
Jannasch H.
W. The genus Spirillum: a taxonomic study. Int. J. Syst. Bacteriol. 1973, 23, 340–380.
OpenUrl Abstract/FREE Full Text

[124] Hylemon P. B.,

[125] Wells J. S. Jr..,

[126] Krieg N. R.,

[127] Jannasch H.

[128] 24.
Garrity G.
Vancanneyt M.,
Segers P.,
Abraham W.,
De Vos P.
Brevundimonas. In Bergey's Manual of Systematic Bacteriology; Garrity G. Ed.; Springer: New York, 2009; Vol. 2, Part C, pp 308–316.
OpenUrl

[129] Garrity G.

[130] Vancanneyt M.,

[131] Segers P.,

[132] Abraham W.,

[133] De Vos P.

[134] 25.
Garrity G.
Willems A.,
Gillis M.
Hydrogenophaga. In Bergey's Manual of Systematic Bacteriology; Garrity G. Ed.; Springer: New York, 2009; Vol. 2, Part C.

[135] Garrity G.

[136] Willems A.,

[137] Gillis M.

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References

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The Importance of Accurate Microorganism Identification in Microbial Challenge Tests of Membrane Filters—Part I

References

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