Papers

This is the most comprehensive list of expert papers published. These papers can be found on the internet via publication search engines like http://nces.ed.gov/pubsearch/.

 

Adsorption
Andrade, J.D., (1985).  Principles of protein adsorption, in Surface and Interfacial Aspects of Biomedical Polymers, Vol. 2, Protein Adsorption (J.D. Andrade, ed.), Plenum, New York, pp. 1-79.

Bowen, R.W. and Gan, Q., (1991). Properties of microfiltration membranes: Adsorption of BSA at Polyvinylidene fluoride membranes, J. Colloid Interface Sci., 144: 254-261.

Brophy, R.T. and Lambert, W.J., (1994). "The Adsorption of Insulintropin to Polysaturate Sterilized Filters", PDA Journal of Pharm. Sci. And Tech. 48 (2): 92-94.

Brose, D.J., and Waibel, P., (1996). "Adsorption of Protein in commercial Microfiltration Capsules", BioPharm. 9(1);36-39.

Brose, D.J. and Hendricksen, G., (1994). "A Quanitative Analysii of Preservative Adsorption on Microfiltration membranes", Pharmaceutical Technology, 18(3), pp. 64-73.

Datar, R., Martin, J.M. and Manteuffel, R.I., (1992). Dynamics of protein recovery from process filtration systems using microporous membrane filter cartridges, J. Parenter. Sci. Technol. 46(2): 35-42.

Detyna, J., (1995). Adsorption validation for aseptic filtration, J. Validation Tech., 1(4): 46-50.

Dillman, W.J. and Miller, I.F., (1973). On the adsorption of serum proteins on polymer membranes, J. Colloid Interface Sci., 44:221-241.

Ghanem, A.H., (1974). "Adsorption of Drugs on Filter Membranes," Egypt, J. Pharm. Sci., 15:51-59.

Hawker, J. and Hawker, L. M., (1975). "Protein Losses During Sterilization by Filtration," Lab. Practice, 24: 805-807, 814.

Horbett, T.A.,(1992). Adsorption of proteins and peptides at interfaces, in Stability of Protein Pharmaceuticals, Part A: Chemical and Physical Pathways of Protein Degradation (T. J. Ahem and M. C. Manning, eds.), Plenum, New York, pp. 195-214.

Kim, M., et al., (1994). "Reduction of Nonselective Adsorption of Proteins by Hydrophilization of Microfiltration Membranes by Radiation-Induced Grafting," Biotechnol. Prog., 10(1), 114-120.

Marshall, A.D., Munro, P. A. and Tragdgardh, G., (1993). Effect of protein fouling in micro-filtration and ultrafiltration on permeate flux, protein retention and selectivity: A literature review, Desalination, 91:65-108.

Martin, J.M. and Manteuffel, R.L., (Nov./Dec. 1998). "Protein Recovery From Effluents of Microporous Membranes,":Biopharm., pp.20-25.

Mei-Fang Chang, White, J.L., Naib, S.L. and Heu, S.L., (1997). "Role of the Electrostatic Attractive Faire in the Adsorption of Protein by Aluminum Hydroxide Adjutant," PDA 51 (1):25-29.

Meltzer, T.H., (1984). "Polymeric Surfaces and Protein Adsorption , Society of Manufacturing Engineers, Ann Arbor, Michigan.

Meltzer, T.H. and Jornitz, M.W., (1998). "Filtration in the Biopharmaceutical Industry", Marcel Dekker, New York.

Naido, N.T., Price, C.H., and McCarthy, T.J., (1972). "Preservative Loss from Ophthalmic Solutions During Filtration Sterilization," Aust. J. Pharm. Sci., NS 1(1): 16-18.

Air/Vent Filter
Bardat, A., Chatenet, E. and Schmitthauseler. R., (1997). "Automatic Integrity Testing of Autoclave and Freeze-Dryer Inlet Filters", Pharmaceutical Engineering, Nov/Dec 1997.

Bardat, A., Schmitthauseler, R., Chatenet, E., and Cappia, J.M., (1996). "Validation of the drying procedure for freeze-dryer inlet filters after the Water Intrusion Integrity Test", European Journal of Parenteral Sciences, 1(4).

Blakie, E.W., (1987), "Theory and Practice of Compressed Air Filtration and Sterilization in the Production of Antibiotics" in T. H. Meltzer, ed., Filtration in the Pharmaceutical Industry, Marcel Dekker, New York, Vol. 19:941-979.

Bruckshaw, N. B., (1973). "Removal of Contamination from Compressed Air," Filtration and Separation, 10(3), 296-298, 300, 302, 315.

Bruno, C.F., and Szabo, L. A., (1983). "Fermentation Air Filtration Upgrading by Use of Membrane Cartridge Filters, Biotech. Bioeng., 25, 1223-1227.

Cole, J. C., (1977). "Consideration in Applications of Bacteria Retentive Air Vent Filters", Pharm. Tech. 1: 49-53.

Conway, R. S. (1984).  "State of the Art in Fermentation Air Filtration," Biotech.  Bioeng., 26, 844-847.

Davies, C.M., (1973). Air Filtration, p. 123, Academic Press, London, U.K.

Decker, H.M., Buchanan, L.M., Hall, L.B. and Goddard, K.R., (1962). "Air Filtration of Microbial Particles," Public Health Service Publication 953, U.S. Government Printing Office, Washington, D.C.

Decker, H.M., Harstad, J.B., and Lense, F.T., (1957). "Removal of Bacteria from Air Streams by Glass Fiber Filters," J. Air Pollution Control, 7 pp. 15-16.

Duberstein, R., and Howard, G., Jr. (1978).  "Sterile Filtration of Gases: A Bacterial Aerosol Challenge Test," J. Parenteral Drug Assoc., 32(4), 192-197.

Fay, T., (1995). "Process Air- Breathing Life Into Process Plants", Chemical Engineering, Feb. 1995, pp. 86-93.

Feldman, K. H., Mohrig, W. and Stapel A. G., (1985), "Druckluftvertellung in der Praxis", Resch Verlag KG, Munchen.

Fuchs, N.A., (1964). "Mechanics of Aerosols" by C.N. Davies, Macmillan, New York.

Grant, D.C., (I988), "Generation and Maintenance of Process Gases with Extremely Low Particle Levels", TSI Journal of Particle Instrumentation, Vol. 3 No. I.-3-II.

Grant, D. C., Liu, B.Y.H., Fisher, W.G. and Bowling. R.A., (1988). Particle capture mechanisms in gases and liquids.- An analysis of operative mechanisms, Proceedings of the 34th Annual Meeting of the Institute of Environmental Sciences.

Hoffmann, A. C., de Jonge, R., Arends, H., Hanrats, C., (September 1995). "Evidence of the Natural Vortex Length and its Effect on the Separation Efficiency of Gas Cyclones", Filtration & Separation, pp. 799 - 804.

Jaenchen, R., (1988). "Verfahrenstechnisch relevante Parameter in der Fermenter Abluftfiltration", CAV.

Johnston, S., Parks, S.R., Bennett, A.M., and Benbough, J.E., (April 1995). "Integrity Testing Air Sterilizing Filters: A Comparison of Aerosol Challenge with Airborne Microbiological Challenge Methods", Pharm. Tech. Europe, pp. 16-25.

Jornitz, M.W., (1998). "Aspects of Air and Gas Filtration in the Biopharmaceutical Industry," Chapter 21 in Filtration in the Biopharmaceutical Industry, Eds., Meltzer, T.H. and Jornitz, M.W., Marcel Dekker, New York, NY.

Jornitz, M.W., Waibel, P.J. and Meltzer, T.H., (October 1994). "The Filter Integrity Test Correlations," Ultrapure Water, pp. 59-64.

Jornitz, M.W., (1998). "Proposal of Isolator Venting with Sterilizing Grade Membrane Filter Cartridges", Cleanroom Technology Newsletter No. 134, pp. 3-5

Jornitz, M.W., (1999). "Aerosol Challenge Testing: Considerations for Sterilizing Grade Membrane Filters", Journal of Validation Technology, Vol 5, No. 9, pp 324-326

Stering, M., Jornitz, M.W., Meltzer, T.H., (2004). "Aerosol Challenging of Vent Filters: Titre Reduction at Different Humidities and Flow Rates", Pharm. Tech. Vol. 16, No. 10., pp 28-32

Jornitz, M.W., (1999). "Points to consider: Isolator venting using membrane filters", European Journal of Parenteral Sciences, 4(4), pp. 143-146

Kastelein, J., Logtenberg, M.T., Hesselink, P.G.M., (1991). "Test Methodology for Membrane Gas Filters by TBAC Testing", BFE Vol.8, No.7/8, pp. 403-405.

Keating, P., Levy, R., Payne, M., Proulx, S., Rowe, P., and Pearl, S., (March 1992). "Performance Testing of Membrane Based Filters Used in the Filtration of Industrial Fermentation Air", Pharm. Tech. International, pp, 46-58.

Keay, D., (June 1991). "Gas sterilization by filtration", Process Industry Journal, pp. 25-29.

Kronsbein, D. G., (1989). "Filter fiir die Druckluftaufbereitung", F & S Filtrieren und Separieren, Jahrgang 3, Heft 1: 4-10.

Lathrache, R., (January 1991). "Luftfiltration mit Faserschichten (Teil 1) ", Reinraumtechnik pp.26-34.

Leahy, T.J. and Gabler, F.R., (1984). "Sterile Filtration of Gases by Membrane Filters", Biotechnology & Bioengineering 26, pp. 836-843.

Lee, K. W., and Liu, B. Y. H. (1980).  "On the Minimum Efficiency and the Most Penetrating Particle Size for Fibrous Filters," Air Poll. Control Assoc. J., 30, 377-381.

Leo, F., Auriemmunc, M., Ball, P. and Sunderam, S., (1997). "Application of Oxygen Filtration for Entancal Sterility Assurance", Pharmaceutical Filter Operations, BFS News, pp. 15-24.

Liu B.Y.H., Rubow, K.L., and Pui, D.Y.H., (1985). "Performance of HEPA and ULPA Filters", 31st Annual Meeting of the Institute of Environmental Science.

Liu, B.Y.H., Pui, D.Y.H. and Robow, K.L., (1983). "Characteristics of Air Sampling Filter Media," in Aerosols in the Mining and Industrial Work Environments, Vol. III, V. A. Marple and B. Y. H. Liu, Eds., Butterworth Press, Woburn, Mass., Chap. 70.

Liu, B.Y.H. and Lee, K.W., (1975). "An Aerosol Generator of High Stability," Amer. Ind. Hygiene Assoc. J., 36, 161-186.

Maxon, M.D. and Gadon, E.L., (1956). "Fibrous Filters for Air Sterilization: Experimental Studies with a Pilot Scale Filters," Ind. Eng. Chem., 48, 2177-2179.

Meltzer, T.H. and Jornitz, M.W., (1998). "Filtration in the Biopharmaceutical Industry", Marcel Dekker, New York.

Mohrig, W., (1988). "Druckluft Praxis, erzeugen - aufarbeiten- verteilen- anwenden", Resch Verlag, KG, Muenchen, Germany.

Analytical Filtration
Denee, P.B., and Stein, R.L., (1971/1972). "An Evaluation of Dust Sampling Membrane Filters for Use in the Scanning Electron Microscope," Powder Tech., 5:201-204.

Bacteria Challenge Testing
ASTM Committee F-21, (1988). Standard test methods for determining bacterial retention of membrane filters utilized for liquid filtration, Annual Book of ASTM Standards, American Society for Testing and Materials, Philadelphia, pp 790-795.

Carter, J., (1996)."Evaluation of Recovery Filters for Use in Bacterial Retention Testing of Sterilizing-Grade Filters", PDA Jour, Pharm.  Sci. & Technology 50(3), pp. 147-154.

Carter, J.R. and Levy, R.V., (1998). Microbial Retention Testing in the Validation of Sterilizing Filtration". in Filtration in the Biopharmaceutical Industry. Meltzer, T.H. and Jornitz, M.W., Eds., Marcel Dekker, New York.

HIMA, (1982). Microbial Evaluation of Filters for Sterilizing Liquids, Document No. 3, Volume 4. Health Industry Manufacturers Association, Washington, D.C.

Howard, J. G. and Duberstein, R.,. (1980). A case of penetration of 0.2- m rated membrane filters by bacteria, J. Parenter. Drug Assoc, 34:95 - 102.

Johnston, P.R. and Meltzer, T.H., (1979). "Comments on Organism Challenge Levels in Sterilizing-Filter Efficiency Testing," Pharm.  Tech.:3(11): 66- 70, 110.

Jornitz, M.W., Meltzer, T.H., (2003). "Opinion Paper - Organism challenge levels at the final filter", European Journal of Parenteral and Pharmaceutical Science, pp. 55-57

Leahy, T.J., (1983). "Validation of Bacterial Retention by Membrane Filters: A Proposed Approach for Determining Sterility Assurance," PhD thesis, Plant and Soil Sciences Department, University of Massachusetts, Amherst.

Leahy, T.J.; Sullivan, M.J., (1978). "Validation of Bacterial Retention Capabilities of Membrane Filters", Pharmaceutical Technology 2(11) pp. 64-75.

Levy, R.V., (1987). The effect of pH, viscosity, and additives on the bacterial retention of membrane filters challenged with Pseudomonas diminuta, American Society for Testing and Materials, Philadelphia.

Levy, R.V. and Leahy, T.J., (1985). "The Effects of pH, Viscosity, and Additives on the Bacterial Retention of Membrane Filters Challenged with Pseudomonas diminuta," PDA Poster Session, Nov, 1985, Philadelphia, Pennsylvania.

Meltzer, T.H. and Jornitz, M.W., (1998). "Filtration in the Biopharmaceutical Industry", Marcel Dekker, New York.

Mouwen, H.C. and Meltzer, T.H., (1993). "Sterlizing Filters; Pore-Size Distribution and the 1 x 107/ cm2 Challenge", Pharmaceutical Technology 17(7), pp. 28-35.

Chemical Compatibility
Baaske, D.M., Amann, A.H., Wagenknecht, D.M., Moores, M., Carter, J.E., Hoyt, H. J., and Stoll, R.G., (1980).  "Nitroglycerin Compatibility with Intravenous Fluid Filters, Containers, and Administration Sets," Amer. J. Hosp. Pharm., 37:201-205.

Berg, H.F., Guess, W.L., and Autian, J., (1965). "Interaction of a Group of Low Molecular Weight Organic Acids with Insoluble Polyamides I. Sorption and Diffusion of Formic, Acetic, Propionic, and Butyric Acids into Nylon 66," J. Pharm. Sci., 54(l):79-84.

Helenius, A. and Simons, K., (1975). "Solubilization of Membranes by Detergents", Biochimica et Acta 415, pp. 29-79.

Lukaszewiez, R.C., and Meltzer, T.H., (1980). "On the Structural Compatibilities of Membrane Filters," J. Parenteral Drug Assoc., 34(6): 4 63- 4 72.

Cross-Flow Filtration (aka Tangential Flow)
Bowen, B.D., Levine, S., and Epstein, N., (1976). "Fine Particle Deposition in Laminar Flow Through Parallel Plates and Cylindrical Channels, J. Colloid Interface Sci., 54(3) : 375- 390.

Brose, D.J., Dosmar, M., Cates, S., and Hutchinson, F., (1996). Studies on the scale-up of Crossflow filtration devices.  J. Pharm Sci. and Techno., 50(4):252-260.

Brown, S., and Fuller, A.C., (1993). "Depyrogenation of pharmaceutical solutions using submicron and ultrafilters", J. Parent.  Sci.  Technol., 47(6):285-288.

Dosmar, M. and Brose, D., (1998). "Crossflow Filtration," Chapter 16: "Filtration in the Biopharmaceutical Industry",:Eds., Meltzer, T.H. and Jornitz, M.W.; Marcel Dekker, New York.
Elford, W.J., (1933)."The Principles of Ultrafiltration as Applied in Biological Studies", Proceedings of the Royal Society, 112B, pp. 384-406, London, U.K.

Erbe, F., (1933). "Die Bestimmung der Porenverteilung Nach lhrer Grosse in Filtern und Ultra-Filtern," Kolloid Z., 63(3): 277-285.

Erbe, F.F., (1932). "Blockierungsphenomene bei Ultrafiltern," Kolloid Z., 59(l):32-44; 59(2): 195-206.

Ferry, J. D., (1935). "Ultrafilter Membranes and Ultrafiltration," Chem.Rev., 18(3):373-447.

Gabler, F.R., (1986). "Cell Processing Using Tangential Flow Filtration, in Mooyoung, Ed., Comprehensive Biotechnology, Pergamon Press, Elmsford, New York.

Jacobs, S., (1972). "The Distribution of Pore Diameters in Graded Ultrafilter Membranes", Filtration and Separation, 9(5), pp. 525-530.

Johnson, D. S., Lin, K., Fitzgerald, E., and LePage, B., (1980). "Depyrogenation of Human Chorionic Gonadotropin", in A. R. Cooper, Ed., Ultrafiltration Membranes and Applications, Polymer Science and Technology, Vol. 13, p. 475, Plenum, New York.

Korin, A., (October 15-17, 1990)."Economic Considerations of Cross Flow Filtation", Eighth Annual Membrane Technology/Planning Conference & First High-Tech Separation Symposium, Newton, MA

Levy, P., and Shehan, J., (April 1991). Performance characteristics of polysulfone and cellulose membranes for the ultrafiltration of biological process streams, Biopharm.,:24-33.

Marshall, A.D., Munro, P. A. and Tragdgardh, G., (1993). Effect of protein fouling in micro-filtration and ultrafiltration on permeate flux, protein retention and selectivity: A literature review, Desalination, 91:65-108.

Matsuo, I., (February 26-28, 1991). "Novel Ultrafiltration Module", Proceedings of Tenth Annual Semiconductor Pure Water Conference, pp. 108-127, Santa Clara, CA.

Meltzer, T.H. and Jornitz, M.W., (1998). "Filtration in the Biopharmaceutical Industry", Marcel Dekker, New York.

Nelsen, L.L., (1978). "Removal of Pyrogens from Parenteral Solution by Ultrafiltration, " Pharm. Tech., 2:46-49.

Depth/Pre-filter
Meltzer, T.H., (1987). "Chapter 1: Depth-Filters, Particles and Filter Ratings", Filtration in the Pharmaceutical Industry, pp. 3-60, Marcel Dekker, New York

Meltzer, T.H. and Jornitz, M.W., (1998). "Filtration in the Biopharmaceutical Industry", Marcel Dekker, New York.

Disposable Technology
Priebe, P.M., Jornitz, M.W., (2004). "Disposable Technology Enhances Aseptic Processing", Pharmaceutical Formulation & Quality November 2004, pp 34-35

Economics of Filtration/Systems
Cole, J.C. and Shumsky, R.H., (1977). "Filter Sizing for Economics; Liquid Systems," Pharm. Tech., 1(6), 39-41.

Jornitz, M.W., Soelkner, P.G., Meltzer, T.H., (2002). "Sterile Filtration - A Review of the Past and Present Technolgies", PDA Journal of Science and Technology, Vol 56, No. 4, pp 192-196

Jornitz, M.W., Soelkner, P.G., Meltzer, T.H., (2003). "The Economics of Modern Sterile Filtration", Pharm. Tech. Vol. 27, No.3, pp 156-166

Jornitz, M.W., Soelkner, P.G., Meltzer, T.H., (2003). "Modern Sterile Filtration - The Economics", Pharm. Tech. Vol. 15, No.6, pp. 29-32

Jornitz, M.W. (2004). "Special Report - New Technologies Optimize Biotech Process Efficiency", Pharm. Tech, Vol 28, No. 6, pp. 40-50

Jornitz, M.W., Meltzer, T.H., Bromm, H. and Priebe, P.M., (2004). "Testing for the Optimal Filter Membrane, Required Prerequisites", Genetic Engineering News, Vol 24, No. 13, pp. 50-51

Jornitz, M.W., Meltzer, T.H., Bromm, H. and Priebe, P.M., (2005). "Choosing the Appropriate Membrane Filter - Test Requirements", PDA Journal of Science and Technology, Vol 59, No. 2, pp. 96-101

Jornitz, M.W., (2005). "Comparability Filterability Trials: The Utilization of Appropriate, Effective Filtration Area", BioPharm International September 2005

Korin, A., (October 15-17, 1990). "Economic Considerations of Cross Flow Filtation", Eighth Annual Membrane Technology/Planning Conference & First High-Tech Separation Symposium, Newton, MA

Maynard, J., Meltzer, T.H., Jornitz, M.W. and Priebe, P.M., (2005). "Sterilizing Filters: Find the Right Flow, Size them Right", Pharmaceutical Manufacturing September 2005, pp. 38-44

Priebe, P.M., Jornitz, M.W., Meltzer, T.H., (2003). "Making an Informed Membrane Filter Choice - Criteria to Consider", BioProcess International Vol. No. 10, pp. 64-66

Priebe, P.M., Jornitz, M.W., Meltzer, T.H., (2004). "Selection and Testing of High Flow Membrane Filters", BioProcess International Industry Yearbook 2004, pp. 2

Extractables/Leachables
American Society for Testing and Materials, (1984). "Quantity of Water-Extractable Matter in Membrane Filters," ASTM Standard D-3861, ASTM, Philadelphia.

Cahn, R.D., (1967). "Detergents in Membrane Filters," Science, 155:195-196.

Colton, R., Okhio, L., Reif, O.W., Jornitz, M.W. and Trotter, A.M., (2005). "Options for Extractables and Leachables Analysis in Filters", Pharma-Manufacturing January 2005

Colton, R., Okhio, L., Jornitz, M.W., (2006). "Test Methodologies And Analysis of Extractables And Leachbales", Pharma-Magazine September/October 2006, pp. 24-30

Cooney, D.L., (1980). "Interference of Contaminants from Membrane Filters in Ultraviolet Spectrophotometry," Anal. Chem., 52:1068-1071.

Goel; V., Leszczak; J. and Stone, T.E., (1994). Methodology for Analysis of Filter Extractables: A Model Stream Approach, p. 116.

Mazzu, A.L. and Smith, C.P., (1984). "Determination of Extractable Methylene Dianiline in Thermoplastic Polyurethanes by HPLC," J. of Biomedical Materials Research, 18, 961-968.

Meltzer, T.H. and Jornitz, M.W., (1998). "Filtration in the Biopharmaceutical Industry", Marcel Dekker, New York.

Filtration Applications
Aicholtz, P., Wilkins, R. and Gabler, R., (1987). Sterile filtration under conditions of high pressure and bacterial challenge levels, J. Parenteral Drug Assoc. 41:117-120.

Aranha, H. and Meeker, J., (1995). Microbial retention characteristics of 0.2-microns-rated nylon membrane filters during filtration of high viscosity fluids at high diffterential pressure and varied temperatures, J. Pharm.. Sci. Technol., 49:67-70.

Badenhop, C.T., Spann, A.T and Meltzer, T.H., (1970). "A Consideration of Parameters Governing Membrane Filtration," in J.E. Flinn, Ed., Membrane Science and Technology, Plenum, New York, pp. 120-138.

Blanden, P.D., James, J.B., Krygier, V. and Howard, G., Jr, (1991). "Comparison of Bacterial and Endotoxin Retention by Charge-Modified Sterilizing Grade Filters During Intermittent Long Term Use", Journal of Parenteral Science and Technology 45(5), pp. 229-232.

Brock, T.D., (1983). "Membrane Filtration: A User's Guide and Reference Manual", Science Technology., pp. 55-58, Madison, WI .

Brown, S., and Fuller, A.C., (1993). "Depyrogenation of pharmaceutical solutions using submicron and ultrafilters", J. Parent.  Sci.  Technol., 47(6):285-288.

Bruckshaw, N. B., (1973). "Removal of Contamination from Compressed Air," Filtration and Separation, 10(3), 296-298, 300, 302, 315.

Bruno, C.F., and Szabo, L. A., (1983). "Fermentation Air Filtration Upgrading by Use of Membrane Cartridge Filters, Biotech. Bioeng., 25, 1223-1227.

Dutka, B.J. (1981), Membrane filtration: application, techniques, and problems. Marcel Dekker, New York.

Fiore, J.V., and Babineau, R.A., (1979). "Filtration, an Old Process with a New Look," Food Technol., 33: 67-72.

Galanos, C.E., Rietschel, E.T., Ludertiz, O., Westphol, 0., Kim, Y.B.and Watson, D.W., (1972). "Biological Activity of Lipid A Complex with Bovine Serum Albumin," Eur. J. Biochem., 31:230-233.

Garvan, J.M. and Gunner, B.W., (1971). "Particulate Contamination of Intravenous Solutions" British Journal of Clinical Practice 25, pp. 119-121.

Grant, D.C., Peacock, S.L.and Accomazzo, M.A., (1986)."A Comparison of Particle Shedding Characteristics of High Purity Water filtration Cartridges" Transcripts of Fifth Annual Semiconductor Pure Water 'Conference, pp. 252-277.

Hango, R. A., Syverson, W.A., Miller, M.A. and. Fleming, M. J., Jr., (1989).  DI water point of use filter program for 1-MB DRAM semiconductor manufacture, Transcripts of Eighth Annual Semiconductor Pure Water Conference, Santa Clara, CA,  January 18-20, pp. 73-94.

Harris, J.E., McKee, T.R., Wilson, K.C., Jr., and Whitehouse, U. G., (1972). "Preparation of Membrane Filter.  Samples for Direct Examination with an Electron Microscope " Limnol. Oceanogr., 17(5):784-787.

Johnston, P.R., (1998)."Chapter 3: Particles In Fluids". Fundamentals of Fluid Filtration, A Technical Primer, 2nd Edition, Tall Oaks Publishing Company, Littleton, CO

Johnston, P.R., (1997). Fluid Sterilization By Filtration, 2nd Ed., Interpharm Press, Buffalo Grove, IL.

Keating, P., Levy, R., Payne, M., Proulx, S., Rowe, P., and Pearl, S., (March 1992). "Performance Testing of Membrane Based Filters Used in the Filtration of Industrial Fermentation Air", Pharm. Tech. International, pp, 46-58.

Knight, R.A., Fiore, J. and Rossitto, J.V., (1982). "Microporous Membranes as Depth Filters,"World Filtration Congress III, Downingtown, Pennsylvania, Vol. 2, pp. 472-483.

Filter Characteristics
Agrest, M.W., Aleksandrov, M.L., and Reifman, S. (1976). "Structural Characteristics of Porous Membranes," Russ. J. Phys. Chem., 50 (9):541-545.

Aranha, H. and Meeker, J., (1995). Microbial retention characteristics of 0.2-microns-rated nylon membrane filters during filtration of high viscosity.fluids at high diffterential pressure and varied temperatures, J. Pharm.. Sci. Technol., 49:67-70.

Badenhop, C.T., (1983). "The Determination of the Pore Distribution and the Consideration of Methods Leading to the Prediction of Retention Characteristics of Membrane Filters," D. Eng., University of Dortmund, June.

Badenhop, C.T., Spann, A.T and Meltzer, T.H., (1970). "A Consideration of Parameters Governing Membrane Filtration," in J.E. Flinn, Ed., Membrane Science and Technology, Plenum, New York, pp. 120-138.

Brose, D.J., and Weibel, P., (1996). "Adsorption of Protein in commercial Microfiltration Capsules", BioPharm. 9(1);36-39.

Fiore, J.V., and Babineau, R.A., (1979). "Filtration, an Old Process with a New Look," Food Technol., 33: 67-72.

Gelman, C.I, Korin A., and Meltzer, T.H., (1982). "The Development of a New Membrane Prefilter Utilizing Pore-Size Distribution Analysis," World Filtration Congress III, Downingtown, Pennsylvania, pp. 502-507.

Gollan, A. and Parish, B.S., (1985). "Hydrodynamics of Semi-Dense Pleat Design in Pleated Cartridges," Filtration and Separation 22(5): 326-329.

Grant, D. C., Liu, B.Y.H., Fisher, W.G. and Bowling. R.A., (1988). Particle capture mechanisms in gases and liquids.- An analysis of operative mechanisms, Proceedings of the 34th Annual Meeting of the Institute of Environmental Sciences.

Grant, D.C., Peacock, S.L.and Accomazzo, M.A., (1986)."A Comparison of Particle Shedding Characteristics of High Purity Water filtration Cartridges" Transcripts of Fifth Annual Semiconductor Pure Water 'Conference, pp. 252-277.

Grant, D.C. and Zahka, J.G., (1990). "Sieving Capture of Particles by Microporous Membrane Filters from Clean Liquids," Swiss Contamination Control, 3(4a): 160-164.

Inman, F.N., (October 1993). "Microbial Contamination Control in Antibiotic Manufacture" Filtration & Separation, Dept. pp. 543-549.

Jornitz, M.W. (2002). "Filters and Filtration" book chapter in Encyclopedia of Pharmaceutical Technology, Marcel Dekker, NY May 2002

Jornitz, M.W., Meltzer, T.H., (2002). "The Mechanics of Removing Organisms by Filtration: The Importance of Theory", Pharm. Tech. May 2002

Krygier, V., (January 1986). "Rating of Fine Membrane Filters Used in the Semiconductor Industry", Transcripts of Fifth Annual Semiconductor Pure Water Conference, pp. 232-25 1, San Fransisco, CA.

Lee, J., Liu, B.Y.H. and Rubow, K.L., (1993), "Latex Sphere Retention by Microporous Membranes in Liquid Filtration", Jane ES xxxvi (1): 26-36.

Lee, K. W., and Liu, B. Y. H. (1980).  "On the Minimum Efficiency and the Most Penetrating Particle Size for Fibrous Filters," Air Poll. Control Assoc. J., 30, 377-381.

Lindenblatt, J.; Jornitz, M.W.; Meltzer, T.H.; "Filter pore size versus process validation - a necessary debate ?", European Journal of Parenteral Science, 2002

Marshall, A.D., Munro, P. A. and Tragdgardh, G., (1993). Effect of protein fouling in micro-filtration and ultrafiltration on permeate flux, protein retention and selectivity: A literature review, Desalination, 91:65-108.

Megaw, W.J., and Wiffen, W.D., (1963). "The Efficiency of Membrane Filters," Int. J. Air Water, Pollut., 7, 501-509.

Meltzer, T.H., (1988). "The Pore Structures of Microporous Filters", Ultrapure Water 5(5), pp. 49-55.

Moll, G., (1965). "Elektronenmikroskopische Demonstration des Filtrations - Mechanismsn von Membranenfiltern," Kolloid Zeitschrift 203:20-27.

Nicholaus, N., (1975). "What, When, and Why of Cartridge Filters," Filtration and Separation, 12(2): 155-163.

Filter Housings
Lawton, D., (1986). Technical Selection Guide: Cartridge Filter Housings Filtrite, Filtration Technology, Brunswick Technetics, Timonium, MD.

McAllister, M. and Wolber, P., (1986). "Selecting Filter Housings for Pharmaceutical Processing Applications," Pharm. Manuf., 3(3), 23-27.

Filter Scaling/Filterability
Brose, D.J., Cates, S. and Hutchison, F.A., (1994). "Studies on the Scale-Up of Microfiltration Devices", PDA of Pharm. Sci. and Tech. 48:184-188.

Gollan, A. and Parish, B.S., (1985). "Hydrodynamics of Semi-Dense Pleat Design in Pleated Cartridges," Filtration and Separation 22(5): 326-329.

Hermans, P. H., and Bredee, H. L., (1936).  "Principles of the Mathematical Treatment of Constant-Pressure Filtration," J. Soc.  Chem. Ind., Trans. Commun., 55:1-4.

Jornitz, M.W., Meltzer, T.H., Bromm, H. and Priebe, P.M., (2004). "Testing for the Optimal Filter Membrane, Required Prerequisites", Genetic Engineering News, Vol 24, No. 13, pp. 50-51

Jornitz, M.W., Meltzer, T.H., Bromm, H. and Priebe, P.M., (2005). "Choosing the Appropriate Membrane Filter - Test Requirements", PDA Journal of Science and Technology, Vol 59, No. 2, pp. 96-101

Jornitz, M.W., (2005). "Comparability Filterability Trials: The Utilization of Appropriate, Effective Filtration Area", BioPharm International September 2005

Keating, P., Levy, R., Payne, M., Proulx, S., Rowe, P., and Pearl, S., (March 1992). "Performance Testing of Membrane Based Filters Used in the Filtration of Industrial Fermentation Air", Pharm. Tech. International, pp, 46-58.

Maynard, J., Meltzer, T.H., Jornitz, M.W. and Priebe, P.M., (2005). "Sterilizing Filters: Find the Right Flow, Size them Right", Pharmaceutical Manufacturing September 2005, pp. 38-44

Meltzer, T.H. and Jornitz, M.W., (1998). "Filtration in the Biopharmaceutical Industry", Marcel Dekker, New York.

Nicholaus, N., (1975). "What, When, and Why of Cartridge Filters," Filtration and Separation, 12(2): 155-163.

Guidances
DIN - 38356, (1972) Alleinverkauf der Normen durch Beuth, Vertag GmbH, Oct. 7, Berlin.

EMEA-CPMP, (April 1996). Note for Guidance in Manufacture of the Finished Dosage Form.

FDA, (1993). Sterilization Process Validation-Recommendations for Information To Be Submitted to Human and Veterinary Applications, Food and Drug Administration, Bethesda, MD.

FDA, (1988). Guideline on Sterile Drug Products Produced by Aseptic Processing, Center for Drugs and Biologics and Office of Regulatory Affairs.  Food and Drug Administration, Bethesda, MD.

FDA, (1987). Guidelines on the General Principles of Process Validation, Prepared by the Center for Drugs and Biologics and the Center for Devices and Radiological Health, Food and Drug Administration, Bethesda, MD.

FDA, (September 1985). "Guideline on General Principles of Process Validation", Center for Drugs and Biologicals and Office of Regulatory Affairs, Washington, D.C.

HIMA, (1982). Microbial Evaluation of Filters for Sterilizing Liquids, Document No. 3, Volume 4. Health Industry Manufacturers Association, Washington, D.C.

Heat Sterilization/Sanitization/Desinfection
Adair, F.W., Geffic, S.G. and Heymann, H., (1979). "Lytic Effects of DI or Tri Carboxylic Acids Plus Sodium Dodecyl Sulfate Against Pseudomonas aeruginosa", AntimicrobialAgents and Chemotherapy 16(3), pp. 419-420.

Agalloco, J.P., (1990-A). "Steam Sterilization-In-Place Technology", Journal of Parenteral Science and Technology 44(5), pp. 253-256.

Agalloco, J.P. (1990-B). "Steam in Place", PDA Short Course, Parenteral Drug Association, Philadelphia, PA.

Anwar, H., Das Gupta, M.K. and Costerton, W., (1990). "Testing the Susceptibility of Bacteria in Biofilms to Antibacterial Agents" Antimicrobial Agents and Chemotherapy 34, pp. 2043-2046.

Beckwith, T.D. and  Moser, J.R., (1933)."Germicidal Effectiveness of Chlorine, Bromine, and Iodine", Journal American Water Works Association 25, pp. 367-374.

Berman, D.; Meyers, T.; Chrai, S., (1986). "Factors Involved in Cycle Development of a Steam-in-Place System", Journal Of Parenteral Science and Technology 40(4), pp. 119-121.

Chang, H.W. and Bock, E., (1980)."Pitfalls in the Use Of Commercial Nonionic Detergents for the Solubilization of lntegeral Membrane Proteins: Sulfhydryl Oxidizing Contaminants and Their Elimination", Biochemistry 104, pp.112-117.

Chirol, C.O., Hambleton, R., and Rigby, G. J., (1965).  "Inhibition of Spores of B. Subtilis by Cetrimide Retained on Washed Membrane Filters, "J. Appl. Bacteriol.. 28:122-330.

Conley, J.D. and Puzig, E.H., (1987) "Bromine Chemistry, An Alternative Dechlorination" Proceeding of the Condenser Technology Symposium of the Electric Power Research Institute.

Denny, V.F., Kopis, E.M. and Marsik, F.J., (1999). "Element for a Successful Disinfectant Program in the Pharmaceutical Environment", PDA Journal of Pharm. Sci. & Tech. 53 (3):115-124.

Denny, V.F. and Marsik, F.J., (1997). "Current Practices in the Use of Disinfectans Within the Pharmaceutical Industry", PDA Journal of Pharm. Sci. & Tech. 57 (6):227-228.

Flemming, H.C., (1984). "Peressigsaure als Desinfectionsmittel", Krankenhaushygiene, Arbeitshygiene, Praev. Medizin 179(2), pp. 97-111.

Frank, J.F. and Kaffi, R.A., (1990). "Surface-Adherent Growth of Listeria monocytogenes Is Associated with Increased Resistance to Surface Sanitizers and Heat", J. Food Prot. 53, pp. 550-554.

Hart, A., (1973). "Antibacteril; Activity of Phenyl Mercuric Nitrate in Zinc Sulfate and Adrenaline Eye-Drops, " J. Pharm. Pharmacol., 25 Supple. (6)"507-508.

Kovary, S.J., Agalloco, J.P. and Gordon, B.M., (1983)."Validation of the Steam-in-Place Sterilization of Disc Filter Housings and Membranes", Journal of Parenteral Science and Technology 37(2), pp. 55-63

Krasner, S.W., McGuire, M.J., Jacangelo,J.G., Potania, N.L., Reagan, K.M., and Aieta, E.M., (1989). "The Occurence of Disinfection By-Products in U.S. Drinking Water", Journal American Water Works Association 8](8), pp. 41-53.

Krysinski, E.P., Brown, L.J. and Marchisello, T.J., (1992). "Effect of Cleaners and Sanitizers on Listeria monocylogenes Attached to Product Contact Surfaces", J. Food Prot. 55, pp. 246-251

Lange, A., (1969). "Uber die Einwirkung van Peressigsaure auf Bacterielle Pyrogen", Naturwiss Reihe 18, pp. 175-1177, Wiss. Z Humboldt-Univ., Berlin.

Latham, T., (1995). "Clean Steam Systems", PharmaceuticalEngineering 15(2), pp. 8-19.

LeChevallier, M.W.; Hasenauer, T.S.; Camper, A.K.; McFeters, G.A., (1984). "Disinfection of Bacteria Attached to GranularActivated Carbon",Applied and Environmental Microbiology 48, pp. 918.-923

LeChevallier, M.W., Cawthon, D.P. and Lee, R.G., (1988). "Factors Promoting Survival of Bacteria in Chlorinated Water Supplies", Applied and Environmental Microbiology 54, pp. 649-654.

LeChevallier, M.W., Cawthon, D.P. and Lee, R.G., (1988). "Inactivation of Biofilm Bacteria", Applied and Environmental Microbiology 54, pp. 2492-2499

Levy, R.V. and Leahy, T.J., (1991). Sterilization Filtration in Disinfection, Sterilization, and Preservation (S.S. Block, ed.), Lea and Febiger, Philadelphia, pp. 527-551.

Lukaszewicz, R.C., Artiss, D.H., and Kaplan, S.J., (1984). "Contamination of Steam Used in Sterilization," Proc. Inst. Environ. Sci., 124-126.

Maltais, J.B. and Stern, T., (1990) "An Evaluation of Various Biocides for Disinfection of Reverse Osmosis Membranes and Water Distribution Systems", Ultrapure Water 7(3), pp. 37-40

McCoy, W.F., (1987). "Chapter 9: Strategies for the Treatment of Biological Fouling", Biological Fouling of Industrial Water Systems: A Problem Solving Approach, Mittelman, M.W.; Geesey, G.G., Eds., Water, Micro Associates, Long Beach, CA.

Meltzer, T.H. and Rice, R.G., (1987). "Chapter, 5: Ultraviolet and Ozone Systems", Biological Fouling of Industrial Water Systems: A Problem Solving Approach, Geesey, G.G.; Mittelman, M.W., Eds., Water Micro Associates, San Diego, CA.

Merrill, D.T. and Drago, J.A., (1980). "Evaluation of Ozone Treatment in Air-Conditioning Cooling Towers", Condenser Biofouling Control, Carey, J.F.; Jorden, R.M.; Aitken, A.H.; Burton, D.T.; Grays, R.H., Eds., Ann Arbor Science, Ann Arbor, MI.

Nebel C. and Nebel, T., (1984). "Ozone: The Process Water Sterilant"', Pharmaceutical Manufacturing 1(2), pp. 16-22.

Integrity Testing
Alkan, M.H. and Groves, M.J., (1978). "The Measurement of Filter Pore-Size by a Gas Permeability Technique", Drug Development and Industrial Pharmacv 4(3), pp. 225-241.

Bardat, A., Chatenet, E. and Schmitthauseler. R., (1997). "Automatic Integrity Testing of Autoclave and Freeze-Dryer Inlet Filters", Pharmaceutical Engineering, Nov/Dec 1997.

Bardat, A., Schmitthauseler, R., Chatenet, E., and Cappia, J.M., (1996). "Validation of the drying procedure for freeze-dryer inlet filters after the Water Intrusion Integrity Test", European Journal of Parenteral Sciences, 1(4).

Baszkin, A., Lyman, D.J., and Meltzer, T.H., (1978). "Theoretical Considerations of Bubble Point Measurement: Solid/Liquid Wetting Interaction," Pharm.-Tech. Int., 2(l):22-31.

Desaulniers, C. and Fey, T., (1990). "The product bubble point and its use in filter integrity testing," Pharm. Tech., 42(10): 42-52.

Dosmar, M., Wolber, P., Bracht, K. Troger, H., and Waibel, P., (1992) "The Water Pressure Integrity Test",  Journal of Parenteral Science and Technology, Vol. 46, No. 4, pp. 102-106.

Dosmar, M., Wolber, P. Bracht, K., Troger, H. and Waibel, P., (1993) "A New In-Place Integrity Test for Hydrophobic Membrane Filters", Filtration and Separation, June 1993, pp 305-309.

Dosmar, M., Wolber, P. Bracht, K., Troger, H., Waibel, P. and Jornitz, M.W. (1993) "An In-Place Test for Hydrophobic Membrane Filters", Laboratory Equipment Digest, February 1993, pp 9-10.

Hart, I., (1998). Private communication to M.W. Jomitz and T.H. Meltzer, published in Sterile Filtration A Practical Approach, Marcel Dekker, NY (2001)

Hofmann, F., (1984). Integrity testing of microfiltration membranes, J. Parenter. Sci. Technol., 38(4): 148-158.

Honold, E. and Skau, E.L., (1954). "Application of Mercury-Intrusion Method for Determination of Pore-Size Distribution in Membrane Filters," Science, 120:805-806.

Jaenchen, R.and Malsy, J., (1993). "Analysis of water penetration through hydrophobic filters as a method for integrity testing", Pall Scientific and Technical Report, SDI 427, Pall Corp., Glen Cove, NY.

Johnston, PR., (1986). "Another View of the Integrity Test (Bubble Point) Applied to Fluid Filter Media," Fluid Filtration; Liquid Vol. II ASTM-STP 975. Johnston, P.R. and Schroeder, H.G., Eds., . ASTM, Philadelphia, Pa.

Johnston, P.R., (1984).  Research Report for ASTM Committee F-21 Regarding Use of Permeability Data to Determine Average Pore Diameter.

Johnston, P.R., (1983). "The Most Probable Pore-Size Distribution in Fluid Filter Media; Parts I and II,11 J. Testing Evaluation, 11(2):117-125.

Johnston, P.R., Lukaszewicz, R.C., and Meltzer, T.H., (1981). "Certain Imprecisions in the Bubble Point Measurement," J. Parenteral Sci.Tech., 35(l):36-39.

Johnston, P.R., and Meltzer, T.H., (1980).  "Suggested Integrity Testing of Membrane Filters at a Robust Flow of Air," Pharm.  Tech., 4(11):49- 59.

Johnston, S., Parks, S.R., Bennett, A.M., and Benbough, J.E., (April 1995). "Integrity Testing Air Sterilizing Filters: A Comparison of Aerosol Challenge with Airborne Microbiological Challenge Methods", Pharm. Tech. Europe, pp. 16-25.

Jomitz, M.W., Brose, D.J., and Meltzer, T.H., (1998). Experimental Evaluations of Diffusive Airflow Integrity Testing, PDA J. Parenter. Sci.  Technol.

Jornitz, M.W., Waibel, P.J. and Meltzer, T.H., (October 1994). "The Filter Integrity Test Correlations," Ultrapure Water, pp. 59-64.

Jornitz, M.W., Agalloco, J.P., Akers, J.E., Madsen, R.E. and Meltzer, T.H., (2001). "Filter Integrity Testing in Liquid Applications, Revisited, Part I", Pharm. Tech. October 2001

Jornitz, M.W., Agalloco, J.P., Akers, J.E., Madsen, R.E. and Meltzer, T.H., (2001). "Filter Integrity Testing in Liquid Applications, Revisited, Part II", Pharm. Tech. November 2001

Jornitz, M.W., Agalloco, J.P., Akers, J.E., Madsen, R.E. and Meltzer, T.H., (2002). "Considerations in Sterile Filtration, Part I: The Changed Role of Filter Integrity Tetsing", PDA Journal of Science and Technology, Vol. 56, No. 1, pp. 4-10

Jornitz, M.W., Meltzer, T.H., (2004). "The Integrity Tests - Choosing Diffusive Airflows or Bubble Points", Pharm. Tech. Supplement October 2004, S24-S39

Kastelein, J., Logtenberg, M.T., Hesselink, P.G.M., (1991). "Test Methodology for Membrane Gas Filters by TBAC Testing", BFE Vol.8, No.7/8, pp. 403-405.

Mehta, D.V., Hauk, D.I., and Meltzer, T.H., (1979). "The Influence of Wetting Agents on the Bubble Points of Membrane Filters," Proc. Second World Filtration Congress, London, pp.387-396.

Meltzer, T.H., (1992). "The Insufficiency of Single Point Diffusive Air Flow Integrity Testing", Journal of Parenteral Science and Technology 46(l), pp. 19-24.

Meltzer, T.H., (1989a). "A Critical Review of Filter Integrity Testing, Part I -The Bubble Point Method; Assessing Filter Compatibility; Initial and Final Testing", Utirapure Water 6(4),
pp. 40-51.

Meltzer, T.H., (January 18-19, 1989b). "A Critical Review of Filter Integrity Testing, Part II - The Diffusive Air Flow and Pressure-Hold Methods: Initial and Final Testing", Ultrapure Water 6(5), pp. 45-56.

Meltzer, T.H. and Jornitz, M.W., (1998). "Filtration in the Biopharmaceutical Industry", Marcel Dekker, New York.

Meltzer, T. H., Madsen, R.E., Jr. and Jomitz, M.W., (March/April 1999), "Considerations for Diffusive Airflow Integrity Testing", PDA Journal of Pharmaceutical Science and Technology, Vol. 53, No. 2: 56-59.

Meltzer, T.H., Jornitz, M.W. and Waibel, P.J., (1994). "The Hydrophobic Air Filter and the Water Intrusion Test", Pharmaceutical Technology 18(9), pp. 76-87.

Meltzer, T.H., Jornitz, M.W. and Waibel, P.J., (1995). "Current Views of Present Integrity Testing Practices", Pharmaceutical Technology, April 1995, pp. 92-98.

Meltzer, T.H. and Meyers, T. R., (1971). "The Bubble Point in Membrane Characterization," Bull. Parenteral Drug Assoc., 25:165-173.

Spanier, H.J., Jornitz, M.W., (1998). "Fully Automated Systems for Integrity Testing of Sterilizing Grade Filters", PDA Journal of Science and Technology, pp. 52

Tarry, S.W., Trotter, A.M., Jornitz, M.W. and Boncore, N., (1996), "The Water Intrusion Test for Testing Hydrophobic Membrane Filters", BFS News Decmber 1996

Waibel, P.J., Jornitz, M.W. and Meltzer, T.H., (199). "Diffusive Airflow Integrity Testing", PDA Journal of Pharmaceutical Science and Technology 50/5, pp. 311-316.

Membrane Characteristics
Agrest, M.W., Aleksandrov, M.L., and Reifman, S. (1976). "Structural Characteristics of Porous Membranes," Russ. J. Phys. Chem., 50 (9):541-545.

Alkan, M.H. and Groves, M.J., (1978). "The Measurement of Filter Pore-Size by a Gas Permeability Technique", Drug Development and Industrial Pharmacv 4(3), pp. 225-241.

American Society for Testing and Materials, (1980). "Pore-Size Characteristics of Membrane Filters for Use with Aerospace Fluids," ASTM Standard F-316, ASTM, Philadelphia.

Badenhop, C.T., (1983). "The Determination of the Pore Distribution and the Consideration of Methods Leading to the Prediction of Retention Characteristics of Membrane Filters," D. Eng., University of Dortmund, June.

Beasley, J.K., (1977). "The Evaluation and Selection of Polymeric Materials for Reverse Osmosis Membranes", Desalination 22, pp. 181-189.

Blanden, P.D., James, J.B., Krygier, V. and Howard, G., Jr, (1991). "Comparison of Bacterial and Endotoxin Retention by Charge-Modified Sterilizing Grade Filters During Intermittent Long Term Use", Journal of Parenteral Science and Technology 45(5), pp. 229-232.

Brock, T.D., (1983). "Membrane Filtration: A User's Guide and Reference Manual", Science Technology., pp. 55-58, Madison, WI .

Brose, D.J. and Hendricksen, G., (1994). "A Quanitative Analysii of Preservative Adsorption on Microfiltration membranes", Pharmaceutical Technology, 18(3), pp. 64-73.

Carazonne, M. Orecco, D. Fava, M. and Sansin, P., (1985). "A New Type of Positively Charged Filter: Preliminary Test Results," J. Parenteral Sci. and Tech. 39 (2): 69-74.

Datar, R., Martin, J.M. and Manteuffel, R.I., (1992). Dynamics of protein recovery from process filtration systems using microporous membrane filter cartridges, J. Parenter. Sci. Technol. 46(2): 35-42.

Elford, W. J., (1931). "A New Series of Graded Colloidion Membranes Suitable for General Microbiological Use Especially in Filterable Virus Studies," J. Path. Bact., 34:505-521.

Emory, S.F., Koga, Y., Azuma, N., and Matsumoto, K., (1993). "The Effects of Surfactant Type and Latex-Particle Feed Concentration on Membrane Retention", Ullrapure Water 10(2), pp. 41-44.

Erbe, F., (1933). "Die Bestimmung der Porenverteilung Nach lhrer Grosse in Filtern und Ultra-Filtern," Kolloid Z., 63(3): 277-285.

Erbe, F.F., (1932). "Blockierungsphenomene bei Ultrafiltern," Kolloid Z., 59(l):32-44; 59(2): 195-206.

Gebott, M.D., Marshall, J.C., and Meltzer, T.H., (1969). "Polymeric Parameters of Cellulosic Support Media Affecting Serum Protein Electrophoresis," J. Appl. Polymer Sci., 13:211-233.

Gillespie, D. and Spiegelman, S., (1965). "A Qualitative Assay for DNA-RNA Hybrids with DNA Immobilized on a Membrane," J. Mol. Biol., 12: pp.829-842.

Helenius, A. and Simons, K., (1975). "Solubilization of Membranes by Detergents", Biochimica et Acta 415, pp. 29-79.

Hiatt, W.C., Vitzthum, G.H., Wagener, K.B., Gerlach, K., and Josefi, C., (1985). "Microporous Membranes Via Upper Critical TemperaturePhase Separation," Material Science of Synthetic Membranes, D. R.Lloyd, Ed. American Chemical Society, Washington, D.C.

Honold, E. and Skau, E.L., (1954). "Application of Mercury-Intrusion Method for Determination of Pore-Size Distribution in Membrane Filters," Science, 120:805-806.

Jacobs, S., (1972). "The Distribution of Pore Diameters in Graded Ultrafilter Membranes", Filtration and Separation, 9(5), pp. 525-530.

Johnston, P.R., (1983). "The Most Probable Pore-Size Distribution in Fluid Filter Media; Parts I and II,11 J. Testing Evaluation, 11(2):117-125.

Katz, M.G., (1982). "Measurement of Pore-Size Distribution in Microporous Filters and Membranes," Proceedings of World Filtration Congress III, pp. 508-512, Downington, PA.

Kesting, R.E., Murray, A.S., Jackson, K. and Newman, J.M., (1981). "Highly Anisotropic Microfiltration Membranes", Pharmaceutical Technology 5(5), pp. 52-60

Kesting, R.E., (1971). Synthetic Polymeric Membranes, McGraw-Hill, Inc., New York, NY, pp. 142-152.

Kim, M., et al., (1994). "Reduction of Nonselective Adsorption of Proteins by Hydrophilization of Microfiltration Membranes by Radiation-Induced Grafting," Biotechnol. Prog., 10(1), 114-120.

Knight, R.A., and Ostreicher, E.A. (1981). "Measuring the Electrokinetic Properties of Charged Filter Media," Filtration and Separation, 18:30-34.

Libby, D.V., Cronin, J.J. and Cunningham, L.L., (1981).  The effect of anisotropy on mixed ester microfiltration membranes, J. Parenter.  Sci.  Technol., 35(6): 276-280.

Lukaszewicz, R.C., Johnston, P.R., and Meltzer, T.H., (1981). "Prefilter/Final Filters: A Matter of Particle/Pore Size Distributions", Journal of Parenteral and Technology 35(l), pp. 40-47.

Lukaszewiez, R.C., and Meltzer, T.H., (1980). "On the Structural Compatibilities of Membrane Filters," J. Parenteral Drug Assoc., 34(6): 4 63- 4 72.

Maier, K. and Scheuermann, E.A., (1960). "Formation of Semipermeable Membranes," Kolloid Z., 171:122-135.

Manegold, E., Komagata, S., and Albrecht, E., (1940). "Uber Kapillarsysteme-XIX/11," Kolloid Z, 93(2/3):167-199.

Marshall,J.C. and Meltzer,T.H., (1976). "Certain Porosity Aspects of Membrane Filters, Their Pore Distributions and Anisotropy", Bulletin of the Parenteral Drug Association 30(5), pp., 214-225.

Martin, J.M. and Manteuffel, R.L., (Nov./Dec. 1998). "Protein Recovery From Effluents of Microporous Membranes,":Biopharm., pp.20-25.

Meltzer, T.H., (1988). "The Pore Structures of Microporous Filters", Ultrapure Water 5(5), pp. 49-55.

Meltzer, T.H., (1986d). "The Advantages of Asymmetric Filter Morphology", Ultrapure Water 3(6). pp. 43-48.

Meltzer, T.H., (1984). "Polymeric Surfaces and Protein Adsorption , Society of Manufacturing Engineers, Ann Arbor, Michigan.

Meltzer, T.H. and Jornitz, M.W., (1998). "Filtration in the Biopharmaceutical Industry", Marcel Dekker, New York.

Meltzer, T.H., Jornitz, M.W. and Mittleman, M.W., (Feb. 17-19, 1997). "Surrogate solution attributes and use conditions: Effects on bacterial cell size and surface charge relevant to filter validation studies," PDA Second Asian Symposium, Osaka, Japan.

Meltzer, T.H., Jornitz, M.W. and Trotter, A.M., (1998). "Application-Directed Selection 0.1 m or 0.2 m Rated Sterilizing Filters," Pharm. Tech., 22 (9): 116-122.

Meltzer, T.H. and Meyers, T. R., (1971). "The Bubble Point in Membrane Characterization," Bull. Parenteral Drug Assoc., 25:165-173.

Microbiology
Akerman, K.K., Kuronen, I. and Kajander, E.O, (1993). "Scanning Electron Micsroscopy of Nanobacteria-Novel Biofilm Producing Organisms in Blood", Scanning Vol. 15, Suppl. III.

American Society for Testing and Materials, (1985). "Enumeration of Aquatic Bacteria by Epifluorescence Microscopy Counting Procedure", pp 632-635 in WATER Vol 11. 02 D-4455 85, Philadelphia, PA.

Anwar, H., Das Gupta, M.K. and Costerton, W., (1990). "Testing the Susceptibility of Bacteria in Biofilms to Antibacterial Agents" Antimicrobial Agents and Chemotherapy 34, pp. 2043-2046.

ASTM Committee F-21, (1988). Standard test methods for determining bacterial retention of membrane filters utilized for liquid filtration, Annual Book of ASTM Standards, American Society for Testing and Materials, Philadelphia, pp 790-795.

Baldwin W.W., R. Myer, T. Kung, E. Anderson, and A.L. Koch, (1995). "Growth and buoyant density of Escherichia coli at very low osmolarities" J.Bacteriol. 177: 235-237.

Baldwin, W.W., Sheu, J.T.M., Bankston, P.W. and Woldringh, C.L., (1988). "Changes in buoyant density and cell size of Escherichia coli is response to osmotic shocks," J. Bacteriol., 170, 170-177.

Baldwin, W.W., Myer, R., Powell, N., Anderson, E., and Koch, A.L., (1995). "Buoyant density of Escherichia coli is determined solely by the osmolarity of the culture medium," Arch. Microbiol., 164, 155-157.

Baldwin, W.W., Myer, R, Kung, T. Anderson, E., and Koch, A.L., (1995).  "Growth and buoyant density of Escherichia coli at very low osmolarities," J. Bacieriol., 177, pp. 235-237.

Blosse, P., Boulter, E. and Sundaram, S., (1998). "Diminutive Bacteria - Implications for Sterile Filtration", Amer Biotechnol. Lab. 16 (12): 38-40.

Carter, J., (1996)."Evaluation of Recovery Filters for Use in Bacterial Retention Testing of Sterilizing-Grade Filters", PDA Jour, Pharm.  Sci. & Technology 50(3), pp. 147-154.

Chirol, C.O., Hambleton, R., and Rigby, G. J., (1965).  "Inhibition of Spores of B. Subtilis by Cetrimide Retained on Washed Membrane Filters, "J. Appl. Bacteriol.. 28:122-330.

Christian, D.A.; Meltzer, T.H., (1986). "The Penetration of Membranes by Organism Grow-Through and Its Related Problems", Ultrapure Water 3(3), pp. 39-44.

Colwell, R.R., (May 9-11, 1994). "Viable but Non-Culturable Bacteria and Their Implications for Water Purification", Ultrapure Water Expo '94, Philadelphia, PA.

Colwell, R.R. and Huq, A., (1995)."Viable but Non-Culturable Bacteria and Their Implications for Water Purification", Ultrapure Water 12(3), pp. 67-74

Conley, J.D. and Puzig, E.H., (1987) "Bromine Chemistry, An Alternative Dechlorination" Proceeding of the Condenser Technology Symposium of the Electric Power Research Institute.

Dahlback, B., Hermannsson, M., Kjelleberg S. and Norkrans, B., (1981). "The hydrophobicity of bacteria-an important factor in the initial adhesion at the air-water interface,"Arch. Microbiol, 128, 267-270.

Davies, D.G. and McFeters, G.A., (1988). Growth and comparitive physiology of Klebsiella oxytocia attached to GAC particles in liquid media. Microb. Ecol., 15:165-175.

DeLuca, P.P., (1983)."Microcontamination Control: A Summary of an Approach to Training", Journal of Parenteral Science and Technology 37(6), pp. 218-224.

Frank, J.F. and Kaffi, R.A., (1990). "Surface-Adherent Growth of Listeria monocytogenes Is Associated with Increased Resistance to Surface Sanitizers and Heat", J. Food Prot. 53, pp. 550-554.

Geertsema-Doornbusch, G.I., Mei, H.C.V.D. and Busscher, H. J., (1993)."Microbial cell surface hydrophobicity. The involvement of electrostatic interactions in microbial adhesion to hydrocarbons," J. Microbiol. Meth., 18, 61-63.

Gerson, D.F. and Zajic, J.E., (1978). "The Biophysics of Cellular Adhesion" in Immobilized Microbiological Cells, K.. Ven Katsubram, Ed., American Chemical Society, Washington, D.C., pp, 29-53.

Gould, M.J., (1993). "Evaluation of Microbial/Endotoxin Contamination Using the L.A.L. Test", Ultrapure Water 10 (6): 43-47.

Haas, C.N. and Karra, S.B., (1984). "Kinetics off Microbial Inactivation by Chlorine: Review of Results in Demand-Free Systems," Water Research 18, pp. 1443-1449.

Hargreaves, P., (1993)."Paul Hargreaves Speaks Out on Pharmaceutical Manufacturing" PDA
Letter 10-13.

Haycock J.W., et al., "Bacterial L-Forms Are Omnipresent in 'Sterile' Culture Sera", Unpublished Communication.

Haycock, J. W., Joho, K.E., Galyon, J.C. and Moses, R.L., (1994).  Bacterial L forms are omnipresent in "sterile" tissue culture sera. Tissue Culture Assoc., Conference on Regulation of Cell and Tissue, NC.

Herald, P.J. and Zottola, E.A., (1987). "Attachment of Listeria monacytogenes and Yersinia enterocolitica to Stainless steel at various temperatures and pH values," J. Food Protect. (abst.), 50, 994.

Innis, M.A., (1990). "A Guide to Methods and Applications", PCR Protocols; Academic Press, San Diego, CA.

Kajander, E.O., Kuronen, I. and Ciftcioglu, N., (1996). "Fatal (Fetal) Bovine Serum, Discovery of Nanobacteria", Mol. Biol. Cell, Suppl., Vol. 7, 517a.

Krysinski, E.P., Brown, L.J. and Marchisello, T.J., (1992). "Effect of Cleaners and Sanitizers on Listeria monocylogenes Attached to Product Contact Surfaces", J. Food Prot. 55, pp. 246-251

Marshall, K.C., (1992). "Biofilms: An Overview of Bacterial Adhesion, Activity, and Control at Surfaces", American Society for Microbiology News 58(4), pp. 202-207.

Meltzer, T.H., Jornitz, M.W. and Johnston, P.R., (1999). "Relative Efficiencies of Double Filters on Tighter Filters for Small Organism Removal," Pharm. Tech. 23 (9): 98-109.

Meltzer, T.H., Jornitz, M.W. and Mittleman, M.W., (Feb. 17-19, 1997). "Surrogate solution attributes and use conditions: Effects on bacterial cell size and surface charge relevant to filter validation studies," PDA Second Asian Symposium, Osaka, Japan.

Mittleman, M.W. and White, D.C., (1990). "The role of biofilms in contamination of process fluids by biological particulates." in Particles in gases and liquids. K.L. Mittal, Ed., Pelnum Press, New York.

Mittleman, M.W., Jornitz, M.W. and Meltzer, T.H., (1998). "Bacterial Cell Size and Surface Charge Characteristics Relevant to Filter Validation Studies," PDA J. Pharm. Sci. Tech. 52 (1): 37-42.

Mittlemann, M.W., Kawamura K., Jornitz M.W. and Meltzer T.H. (2001). "Filter Validation: Bacterial Hydrophobicity, Adsorptive Sequestration and Cell Size Alteration" PDA J. of Science and Technology: 422 - 429

Morita, R.Y., (1985). "Starvation and miniaturization of heterotrophs, with special emphasis on maintenance of the starved viable state." pp. 111-130, in: Bacteria in the natural environments: the effect of nutrient conditions. M. Fletcher and G. Floodgate (ed.), Soc. Gen. Microbiol., London.

Noble, P.T., (1994). "Transport Considerations for Microbiological Control in Piping", J Pharm Sci. & Tech. 48(2), pp. 76-85.

Nystrom, T., Olsson, R.M., and Kjelleberg, S., (1992). "Survival, stress resistance, and alterations in protein expression in the marine Vibrio sp. strain sl4 during starvation for different individual nutrients," Appl. Environ. Microbiol., 58, 55-65.

Quality Assurance/Control
Bowman, F. W., Calhoun, M.P., and White, M., (1967). Microbiological methods for quality control of membrane filters,  J. Pharm. Sci., 56: 222-225.

Bowman, F.W, Calhoun, M.P. and White, M., (1967). Microbiological methods for quality control of membrane filters, J. Pharm. Sci., 56(2 :453-459.

Garvan, J.M. and Gunner, B.W., (1971). "Particulate Contamination of Intravenous Solutions" British Journal of Clinical Practice 25, pp. 119-121.

Gould, M.J., (1993). "Evaluation of Microbial/Endotoxin Contamination Using the L.A.L. Test", Ultrapure Water 10 (6): 43-47.

Sterility/Microbial Testing
Bowman, F.W., (1966). "Application of Membrane Filtration to Antibiotic Quality Control Sterility Testing", J. Pharm. Sci, 55,818- 821.

Clancy, J.L. and Cimini, L., (April 29-May 1, 1991)."Methods for the Improved Recovery of High Purity Water Bacteria." Ultrapure Water Expo '91-East Conference on' High-Purity Water, Proceedings, Philadelphia, PA

Davenport, S.M., (1989). "Design and Use of a Novel Peraectic Acid Study for Absolute Bases Sterility Testing Chambers," J.Pharm.Sci. and Tech. 43 (4), pp.158-166.

Hoadley, A.W., (1981). "Effects of injury on the recovery of bacteria on membrane filters," pp. 413-450.in: Dutka, B.J. (ed.), Membrane filtration: application, techniques, and problems. Marcel Dekker, New York.

Odlaug, T.E., Ocwieja, D.A., Purohit, K.S., Riley, R.M. and Young, W.E., (1984). Sterility assurance for terminally sterilized products without end-product sterility testing, J. Parenter. Sci. Technol., 34(4): 141-147.

Sterilizing Liquid Filtration
Blosse, P., Boulter, E. and Sundaram, S., (1998). "Diminutive Bacteria - Implications for Sterile Filtration", Amer Biotechnol. Lab. 16 (12): 38-40.

Christian, D.A.; Meltzer, T.H., (1986). "The Penetration of Membranes by Organism Grow-Through and Its Related Problems", Ultrapure Water 3(3), pp. 39-44.

Collentro, W.V., (1999). "The Use of 0.1 -  m Membrane Filters in USP Purified Water Systems - Case Histories, Part I", Pharm. Tech.: 176-192

Hawker, J. and Hawker, L. M., (1975). "Protein Losses During Sterilization by Filtration," Lab. Practice, 24: 805-807, 814.

Howard, J. G. and Duberstein, R.,. (1980). A case of penetration of 0.2- m rated membrane filters by bacteria, J. Parenter. Drug Assoc, 34:95 - 102.

Johnston, P.R., (1997). Fluid Sterilization By Filtration, 2nd Ed., Interpharm Press, Buffalo Grove, IL.

Johnston, P.R., (1975). "Submicron Filtration," Filtration and Separation, 1 2(4) : 352-353.

Jornitz, M. W. and Meltzer, T. H., (1999).  "Addressing Uncertainties In Sterile Filtrations; Substituting Double Filters and 0. 1 for 0.2  m Rating", Pharm. Tech. Vol. 12, No. 2, pp. 20-24

Jornitz, M.W. and Meltzer, T.H., (1998). "Sterile Double Filtration," Pharm. Tech., 22 (10): 92-100.

Jornitz, M.W. and Meltzer, T.H., (1998). "Validation of Filtrative Sterilizations," Filtrations in Biopharmaceutical Industry, T.H. Meltzer and M.W. Jornitz, Eds., (Marcel Dekker, New York).

Jornitz, M.W. and Meltzer, T.H., (1998). "Filtrative Particle Removal from Liquids," Filtrations in Biopharmaceutical Industry, T.H. Meltzer and M.W. Jornitz, Eds., (Marcel Dekker, New York).

Jornitz, M.W., Meltzer, T.H., (2000). "Identifying the Sterilizing Grade Filter", Pharm. Tech., pp. 38-46

Jornitz, M.W., Agalloco, J.P., Akers, J.E., Madsen, R.E. and Meltzer, T.H., (2002). "Considerations in Sterile Filtration, Part I: The Changed Role of Filter Integrity Testing", PDA Journal of Science and Technology, Vol. 56, No. 1, pp. 4-10

Jornitz, M.W., Agalloco, J.P., Akers, J.E., Madsen, R.E. and Meltzer, T.H., (2003). "Considerations in Sterile Filtration, Part II: The Sterilizing Filter and Its Organism Challenge: A Critic of Regulatory Standards", PDA Journal of Science and Technology, Vol. 57, No. 2, pp. 88-96

Jornitz, M.W., Meltzer, T.H., (2003). "Opinion Paper - Organism challenge levels at the final filter", European Journal of Parenteral and Pharmaceutical Science, pp. 55-57

Jornitz, M.W., Meltzer, T.H., Lindenblatt, J., (2004). "Which to try first in untested filtrations - 0.1 micron or 0.2/0.22 micron rated membranes ?", Pharmaceutical Formulation & Quality, May 2004, pp. 89-93

Jornitz, M.W., Meltzer, T.H., (2004). "Sterilizing Filtrations with Microporous Membranes", Pharmacopeial Forum Vol. 30 (5), pp. 1903-1910

Karbachsch, M., (1982). "Particle-Free and Sterile Filtration of Pharmaceuticals," Test Methods for Integrated Filtration Systems, Concept Seminar Nov. 19-20, 1982.

Kawamura, K., Jornitz, M.W., Meltzer, T.H., (2000). "Absolute or Sterilizing Grade Filtration - What is required ?", PDA Journal of Science and Technology, November/December 2000, pp. 485-492

Levy, R.V. and Leahy, T.J., (1991). Sterilization Filtration in Disinfection, Sterilization, and Preservation (S.S. Block, ed.), Lea and Febiger, Philadelphia, pp. 527-551.

Lindenblatt, J., Jornitz, M.W., (1999). "0.1 micron vs. 0.2 micron final filtration in BFS operations", BFS News October 1999, pp. 44-48

Madsen, R.E., Jr. and Meltzer, T.H., (1998).  An Interpretation of the Pharmaceutical Industry Survey of Current Sterile Filtration Practices, PDA Journal of Pharmaceutical Science and Technology, Vol. 52, No. 6: 337-339

Meltzer, T.H., (1983). "The Absolute Retention of P. diminuta by 0.2  m-Rated Membrane Filters," XVI Congress Nacional de Ciencias Farmaceuticas, Merida, Yucatan.

Meltzer, T.H. and Jornitz, M.W., (1998). "Filtration in the Biopharmaceutical Industry", Marcel Dekker, New York.

Meltzer, T.H., Jornitz, M.W. and Trotter, A.M., (1998). "Application-Directed Selection 0.1 m or 0.2 m Rated Sterilizing Filters," Pharm. Tech., 22 (9): 116-122.

Meltzer, T.H., Jornitz, M.W., Johnston, P.R., (1999). "Relative Efficiencies of Double Filters or Tighter Filters for Small-Organism Removals", Pharm. Tech. Vol. 23, No. 9, pp. 98-106

Meltzer, T.H., Jornitz, M.W., (2003). "The Sterilizing Filter and Its Pore Size Rating", American Pharmaceutical Review, pp. 44-52

Mouwen, H.C. and Meltzer, T.H., (1993). "Sterlizing Filters; Pore-Size Distribution and the 1 x 107/ cm2 Challenge", Pharmaceutical Technology 17(7), pp. 28-35.

Surface Interactions
Adamson, A.A., (1982). Physical Chemistry of Surfaces, 4th Edition Wiley Interscience, New York.

Andrade, J.D., (1985).  Principles of protein adsorption, in Surface and Interfacial Aspects of Biomedical Polymers, Vol. 2, Protein Adsorption (J.D. Andrade, ed.), Plenum, New York, pp. 1-79.

Berg, H.F., Guess, W.L., and Autian, J., (1965). "Interaction of a Group of Low Molecular Weight Organic Acids with Insoluble Polyamides I. Sorption and Diffusion of Formic, Acetic, Propionic, and Butyric Acids into Nylon 66," J. Pharm. Sci., 54(l):79-84.

Busscher, H.J. and Weerkamp, A.H., (1987). "Specific and non-specific interactions in bacterial adhesion to solid substrata," FEMS Microbiol, Rev., 46,165-173.

Characklis, W.G., (1990). "Microbial Biofouling control," pp. 585-633, in: W. G. Characklis and K. C. Marshall (ed.), Biofilms.  Wiley, New York.

Characklis, W., (1981)."Fouling Biofilm Development: A Process Analysis", Biotechnology & Bioengineering 23, pp. 1923-1940.

Characklis, W., (1973)."Attached Microbial Growths Frictional Resistance Due to Microbial Slimes", Water Research 7, pp. 1249-1258.

Dahlback, B., Hermannsson, M., Kjelleberg S. and Norkrans, B., (1981). "The hydrophobicity of bacteria-an important factor in the initial adhesion at the air-water interface,"Arch. Microbiol, 128, 267-270.

Davies, D.G. and McFeters, G.A., (1988). Growth and comparitive physiology of Klebsiella oxytocia attached to GAC particles in liquid media. Microb. Ecol., 15:165-175.

Emory, S.F., Koga, Y., Azuma, N., and Matsumoto, K., (1993). "The Effects of Surfactant Type and Latex-Particle Feed Concentration on Membrane Retention", Ullrapure Water 10(2), pp. 41-44.

Frank, J.F. and Kaffi, R.A., (1990). "Surface-Adherent Growth of Listeria monocytogenes Is Associated with Increased Resistance to Surface Sanitizers and Heat", J. Food Prot. 53, pp. 550-554.

Gabler, R., (1978). Electrical Interactions in Molecular Biophysics. Academic Press, New York.

Galanos, C.E., Rietschel, E.T., Ludertiz, O., Westphol, 0., Kim, Y.B.and Watson, D.W., (1972). "Biological Activity of Lipid A Complex with Bovine Serum Albumin," Eur. J. Biochem., 31:230-233.

Gebott, M.D., Marshall, J.C., and Meltzer, T.H., (1969). "Polymeric Parameters of Cellulosic Support Media Affecting Serum Protein Electrophoresis," J. Appl. Polymer Sci., 13:211-233.

Geertsema-Doornbusch, G.I., Mei, H.C.V.D. and Busscher, H.J., (1993). "Microbial cell surface hydrophobicity. The involvement of electrostatic interactions in microbial adhesion to hydrocarbons," J. Microbiol. Meth., 18, 61-63.

Gerson, D.F. and Zajic, J.E., (1978). "The Biophysics of Cellular Adhesion" in Immobilized Microbiological Cells, K.. Ven Katsubram, Ed., American Chemical Society, Washington, D.C., pp, 29-53.

Gillespie, D. and Spiegelman, S., (1965). "A Qualitative Assay for DNA-RNA Hybrids with DNA Immobilized on a Membrane," J. Mol. Biol., 12: pp.829-842.

Herald, P.J. and Zottola, E.A., (1987). "Attachment of Listeria monacytogenes and Yersinia enterocolitica to Stainless steel at various temperatures and pH values," J. Food Protect. (abst.), 50, 994.

Knight, R.A., and Ostreicher, E.A. (1981). "Measuring the Electrokinetic Properties of Charged Filter Media," Filtration and Separation, 18:30-34.

Krysinski, E.P., Brown, L.J. and Marchisello, T.J., (1992). "Effect of Cleaners and Sanitizers on Listeria monocylogenes Attached to Product Contact Surfaces", J. Food Prot. 55, pp. 246-251

Langmuir, I., (1918). "The Adsorption of Gases on Plane Surfaces of Glass, Mica, and Platinum",Journal of the American Chemical Society 40, pp. 1361-1401.

Lyttle, C.D.and Routson, L.B., (1995). Minimized virus binding for tests of barrier materials," Appl. Environ. Microbiol., 61, 643-649.

Mafu, A.A., Roy, D., Goulet, J. and Magny, P., (1990). "Attachment of Listeria monocylogenes to Stainless Steel, Glass, Polypropylene, and Rubber Surfaces after Short Contact Times", J. Food Prot. 53, pp. 742-746.

Marshall, K.C., (1992). "Biofilms: An Overview of Bacterial Adhesion, Activity, and Control at Surfaces", American Society for Microbiology News 58(4), pp. 202-207.

Marshall, K.C., Stout, R. and Mitchell, R., (1971). "Mechanisms of the initial events in the sorption of marine bacteria to surfaces," J. Gen. Microbiol, 68,337-348.

Noble, P.T., (1994). "Transport Considerations for Microbiological Control in Piping", J Pharm Sci. & Tech. 48(2), pp. 76-85.

Validation/Qualification
Carter, J.R. and Levy, R.V., (1998). Microbial Retention Testing in the Validation of Sterilizing Filtration". in Filtration in the Biopharmaceutical Industry. Meltzer, T.H. and Jornitz, M.W., Eds., Marcel Dekker, New York.

Detyna, J., (1995). Adsorption validation for aseptic filtration, J. Validation Tech., 1(4): 46-50.

Fennington, G.J. and Howard, G., Jr., (1997). Preparation and evaluation of bacterial stock for filter validation, PDA J. Pharm. Sci. Technol. 51(4): 153-155.

HIMA, (1982). Microbial Evaluation of Filters for Sterilizing Liquids, Document No. 3, Volume 4. Health Industry Manufacturers Association, Washington, D.C.

Johnston, P.R. and Meltzer, T.H., (1979). "Comments on Organism Challenge Levels in Sterilizing-Filter Efficiency Testing," Pharm.  Tech.:3(11): 66- 70, 110.

Jornitz, M.W. and Meltzer, T.H., (1998). "Validation of Filtrative Sterilizations," Filtrations in Biopharmaceutical Industry, T.H. Meltzer and M.W. Jornitz, Eds., (Marcel Dekker, New York).

Jornitz, M.W., Meltzer, T.H., (2001). "Validation of sterilizing grade filtration", Chemical Processing Directions International 2002, pp. 123

Kovary, S.J., Agalloco, J.P. and Gordon, B.M., (1983)."Validation of the Steam-in-Place Sterilization of Disc Filter Housings and Membranes", Journal of Parenteral Science and Technology 37(2), pp. 55-63

Krygier, V., (January 1986). "Rating of Fine Membrane Filters Used in the Semiconductor Industry", Transcripts of Fifth Annual Semiconductor Pure Water Conference, pp. 232-25 1, San Fransisco, CA.

Krygier, V., Latham, M. and Conway, R., (January 1985)."Automatic Particle Measurement in Liquids Used by the Semiconductor Industry Downstream of Fine Membrane Filters", Transcripts of Fourth 4nnual Semiconductor Pure Water Conference, pp. 71-78, San Francisco, CA.

Leahy, T.J., (1983). "Validation of Bacterial Retention by Membrane Filters: A Proposed Approach for Determining Sterility Assurance," PhD thesis, Plant and Soil Sciences Department, University of Massachusetts, Amherst.

Leahy, T.J.; Sullivan, M.J., (1978). "Validation of Bacterial Retention Capabilities of Membrane Filters", Pharmaceutical Technology 2(11) pp. 64-75.

Lee, J., Liu, B.Y.H. and Rubow, K.L., (1993), "Latex Sphere Retention by Microporous Membranes in Liquid Filtration", Jane ES xxxvi (1): 26-36.

Levy, R.V., (1987). The effect of pH, viscosity, and additives on the bacterial retention of membrane filters challenged with Pseudomonas diminuta, American Society for Testing and Materials, Philadelphia.

Levy, R.V., Souza, K.S., Gambale, D.L.H.M., and Neville, C.B., (1991). "The matrix approach: microbial retention testing of sterilizing-grade filters with final parenteral products, part II," Pharm. Technol., 15, 58-68.

Levy, R.V., Souza, K.S. and Neville, C.B., (1990). "The matrix approach: microbial retention testing or sterilizing-grade filters with final parenteral products, part I," Pharm Technol, 14, 160-173.

Levy, R.V. and Leahy, T.J., (1985). "The Effects of pH, Viscosity, and Additives on the Bacterial Retention of Membrane Filters Challenged with Pseudomonas diminuta," PDA Poster Session, Nov, 1985, Philadelphia, Pennsylvania.

Lindenblatt, J.; Jornitz, M.W.; Meltzer, T.H.; "Filter pore size versus process validation - a necessary debate ?", European Journal of Parenteral Science, 2002

Lukaszewicz, R. C. and Meltzer, T. H., (1979). "Concerning Filter Validation," J. Parenteral Drug Assoc., 33(4): 187-194.

Meltzer, T.H., (January 15-16,1987). "An Investigation of Membrane Cartridge Shedding: A Quantative Comparison of Four Competitive Filters", Transcripts of Sixth Annual SemiconductorPure Water Conference, pp. 221-239, Santa Clara, CA.

Meltzer, T.H. and Jornitz, M.W., (1998). "Filtration in the Biopharmaceutical Industry", Marcel Dekker, New York.

Meltzer, T.H. and Lukaszewicz, R.C., (1979). "Filtrative Statistics with Porous Membranes," chapter in Quality in the Pharmaceutical Industry, Ed. M.S. Cooper, Vol. 3, Academic Press, New York, pp:147-213.

Mittlemann, M.W., Kawamura K., Jornitz M.W. and Meltzer T.H. (2001). "Filter Validation: Bacterial Hydrophobicity, Adsorptive Sequestration and Cell Size Alteration" PDA J. of Science and Technology: 422 - 429

Mouwen, H.C. and Meltzer, T.H., (1993). "Sterlizing Filters; Pore-Size Distribution and the 1 x 107/ cm2 Challenge", Pharmaceutical Technology 17(7), pp. 28-35.

Viral Filtration
Elford, W. J., (1931). "A New Series of Graded Colloidion Membranes Suitable for General Microbiological Use Especially in Filterable Virus Studies," J. Path. Bact., 34:505-521.

Water Testing/Treatment
American Water Works Association, (1969) "Chapter 8: Filtration", Water Treatment Plant Design, pp. I17-147, American Water Works Association, New. York, NY.

Amjad, Z., (1988). "Mechanistic Aspects of Reverse Osmosis Mineral Scale Formation and Inhibition", Ultrapure Water 5(6), pp. 23-28.

Anwar, H., Das Gupta, M.K. and Costerton, W., (1990). "Testing the Susceptibility of Bacteria in Biofilms to Antibacterial Agents" Antimicrobial Agents and Chemotherapy 34, pp. 2043-2046.

Argo, D.G. and Ridgway, H.F. "Biological Fouling of Reverse Osmosis Membranes at Water Factory 21", Proceedings of the Water Supply Improvementt Association, Vol. I.

Bates, W.T.; Coulter, B.L.; Thomas, J.D. (1988)."Pretreatment Guidelines for Reverse Osmosis", Ultrapure Water 5(4), pp. 34-41.

Beasley, J.K., (1977). "The Evaluation and Selection of Polymeric Materials for Reverse Osmosis Membranes", Desalination 22, pp. 181-189.

Carter, J.W., (May 1976)."Membrane Techniques (Reverse Osmosis and Ultrafiltration)", Towards Absolute Water, A Survey of Current Water Purification, Proceedings of International Symposium, pp. 103-114, Lane End, High Wycombe, Bucks, England.

Characklis, W.G., (1990). "Microbial Biofouling control," pp. 585-633, in: W. G. Characklis and K. C. Marshall (ed.), Biofilms.  Wiley, New York.

Characklis, W., (1981)."Fouling Biofilm Development: A Process Analysis", Biotechnology & Bioengineering 23, pp. 1923-1940.

Characklis, W., (1973)."Attached Microbial Growths Frictional Resistance Due to Microbial Slimes", Water Research 7, pp. 1249-1258.

Clancy, J.L. and Cimini, L., (April 29-May 1, 1991)."Methods for the Improved Recovery of High Purity Water Bacteria." Ultrapure Water Expo '91-East Conference on' High-Purity Water, Proceedings, Philadelphia, PA

Collentro, W.V., (1999). "The Use of 0.1 -  m Membrane Filters in USP Purified Water Systems - Case Histories, Part I", Pharm. Tech.: 176-192

Colwell, R.R., (May 9-11, 1994). "Viable but Non-Culturable Bacteria and Their Implications for Water Purification", Ultrapure Water Expo '94, Philadelphia, PA.

Colwell, R.R. and Huq, A., (1995)."Viable but Non-Culturable Bacteria and Their Implications for Water Purification", Ultrapure Water 12(3), pp. 67-74

Crits, G.J., (1989). "Pretreatment Methods for Ion-Exchange and Reverse Osmosis," Ultrapure Water 6 (6): 48-57.

Dahlback, B., Hermannsson, M., Kjelleberg S. and Norkrans, B., (1981). "The hydrophobicity of bacteria-an important factor in the initial adhesion at the air-water interface,"Arch. Microbiol, 128, 267-270.

Dawson, M.D.; Novitsky, T.J. and Gould M.J., (1988). "Microbes, Endotoxins and Water", Pharmaceutical Engineering 8(2), pp. 9-12.

Fletcher, C.J. and Pace, V., (1995)."New Performance Standards for Demineralizers Set By Recoflo Technology", American Power Conference, Chicago.

Gagnon, S., Plank, E. and Kling, A., (1993). "Case Study - Reverse Osmosis Problem," Ultrapure Water 10 (7), pp. 33-43.

Gagnon, S.R. and Lesieczka, R., (1994). "AT&T Technologies -- RO System Case Study," Ultrapure Water 11 (4), pp.45-53.

Grant, D.C., Peacock, S.L.and Accomazzo, M.A., (1986)."A Comparison of Particle Shedding Characteristics of High Purity Water filtration Cartridges" Transcripts of Fifth AnnualSemiconductor Pure Water 'Conference, pp. 252-277.

Haas, C.N. and Karra, S.B., (1984). "Kinetics off Microbial Inactivation by Chlorine: Review of Results in Demand-Free Systems," Water Research 18, pp. 1443-1449.

Hall, D., (January 1984a). "A Study of Particulate Contamination in High Purity Water for Integrated Circuit Manufacture," Semiconductor Pure Water Conference, San Jose, Ca.

Hall, D., (1984b). "Variation in Particulate Contamination in High Purity Water," European Semiconductor Design and Production 5 (2): 182-186.

Hango, R. A., Syverson, W.A., Miller, M.A. and. Fleming, M. J., Jr., (1989).  DI water point of use filter program for 1-MB DRAM semiconductor manufacture, Transcripts of Eighth Annual Semiconductor Pure Water Conference, Santa Clara, CA,  January 18-20, pp. 73-94.

LeChevallier, M.W.; Hasenauer, T.S.; Camper, A.K.; McFeters, G.A., (1984). "Disinfection of Bacteria Attached to GranularActivated Carbon",Applied and Environmental Microbiology 48, pp. 918.-923

LeChevallier, M.W., Cawthon, D.P. and Lee, R.G., (1988). "Factors Promoting Survival of Bacteria in Chlorinated Water Supplies", Applied and Environmental Microbiology 54, pp. 649-654.

LeChevallier, M.W., Cawthon, D.P. and Lee, R.G., (1988). "Inactivation of Biofilm Bacteria", Applied and Environmental Microbiology 54, pp. 2492-2499

Luttinger, L.B., (1981). "The Use of Polyelectrolytes in Filtration Processes", Polyelectrolytes for Water and Wastewater Treatment, Schwoyer, W.L.K., Ed., pp. 211-242, CRC Press, Cleveland, OH,

Martin, J.M., (May 24-25, 1995). "Charge Modified Filters for Pharmaceutical Water", Conference on Pharmaceutical Waters, Medical TechSources Atlantic City, NJ

Martyak, J.E., (1988). "Reverse Osmosis/Deionized Water Bacterial Control at the Central Production Facility", Microcontamination 6(l), pp. 34-37, 55.

Matsuo, I., (February 26-28, 1991). "Novel Ultrafiltration Module", Proceedings of Tenth Annual Semiconductor Pure Water Conference, pp. 108-127, Santa Clara, CA.

McAfee, A.L., Nowlin, B. and Beardsley, S., (1990). Pretreatment of an Ion Exchange Demineralizer with Reverse Osmosis", Ultrapure Water 7(7), pp. 54-62.

McCoy, W.F., (1987). "Chapter 9: Strategies for the Treatment of Biological Fouling", Biological Fouling of Industrial Water Systems: A Problem Solving Approach, Mittelman, M.W.; Geesey, G.G., Eds., Water, Micro Associates, Long Beach, CA.

McCoy, W.F. and Costerton, J.W., (1982). "Fouling Biofilm Development in Tubular Flow Systems", Developments in Industrial Microbiology 23, pp. 55 1-558.

Meltzer, T.H., (1997)."Ozone and Its Applications," Chapter 3: Pharmaceutical Water Systems, Tall Oaks Publishing, Inc. Littleton, Co.

Meltzer, T.H., (1996). "Pharmaceutical Water Systems", Tall Oaks, Publishing Inc., Littleton, Colorado.

Meltzer, T.H., (1991a)."Chapter 6: Pharmaceutical Water: Generations, Storage, Distribution and Quality Testing", Sterile Pharmaceutical Manufacturing, Vol. 1, Groves, M.J.; Olson, W.P.; Anisfeld. M.H.. Eds.. Interpharm Press. Buffalo Grove, IL.

Meltzer, T.H. and Rice, R.G., (1987). "Chapter, 5: Ultraviolet and Ozone Systems", Biological Fouling of Industrial Water Systems: A Problem Solving Approach, Geesey, G.G.; Mittelman, M.W., Eds., Water Micro Associates, San Diego, CA.

Meltzer, T.H., Jornitz, M.W., (2002). "Filter Applications for Organic Removal", Ultrapure Water, Vol. 19, No. 4, pp. 39-43

Meltzer, T.H., Collentro, W.V., Zoccolante, G., Jornitz, M.W. and Mittleman, M.W., (2002). "In Defense of Filters in Pharmaceutical Water", PDA Journal of Science and Technology, July/August 2002

Meltzer, T.H., Jornitz, M.W., Tetzlaff, R.F., (2003). "Regulatory Concerns Regarding Filters in Pharmaceutical Water Systems", PDA Journal of Science and Technology, Vol. 57, No. 4, pp. 239-244

Melzter, T.H., Livingston, R.C., Jornitz, M.W., (2003). "Filters and Experts in Water System Design", Ultrapure Water Vol 20, No. 8, pp. 26-30

Meltzer, T.H., Jornitz, M.W., Tetzlaff, R.F., (2004). "Pharmaceuticals - FDA on Filters in Water Systsems at Point-of-Use, Storage, and Distribution", Ultrapure Water Vol 21, No. 1, pp. 40-42

Merrill, D.T. and Drago, J.A., (1980). "Evaluation of Ozone Treatment in Air-Conditioning Cooling Towers", Condenser Biofouling Control, Carey, J.F.; Jorden, R.M.; Aitken, A.H.; Burton, D.T.; Grays, R.H., Eds., Ann Arbor Science, Ann Arbor, MI.

Michaud, D., (1988)."Granulated Activated Carbon", A Series of Three Papers, Water Conditioning and Purification, June pp. 20-26, July pp.38-50, and August pp. 36-41.

Michels, D.L., (1981). "Letter to the Pharmaceutical Industry Re: Validation and Control of Deionized Water Systems", FDA, Rockville, MD., Bureau of Drugs, Assoc. Dir. of Compliance.

Mittelman, M.W., (1990). "Bacterial Growth and Biofouling Control in Purified Water Systems" Biofouling and Biocorrosion in Industrial Systems: Proceedings of the International Workshop on Industrial Biofouling and Biocorrosion,W.Stuttgart Flemming, H.C.; Geesey, G.G., Eds., Springer-Verlag.

Mittelman, M.W., (1987). "Chapter7: Biological Fouling of Purified Water Systems", Biological Fouling of Industrial Water Systems, A Problem Solving Approach, Mittelman, M.W.; Geesey, G.G. Eds., Water Micro Associates, San Diego, CA.

Mittelman, M.W., (1986). "Biological Fouling of Purified Water Systems, Part 3, Treatment", Microcontamination 4(l), pp. 30-40, 70.

Mittelman, M.W., (1985). "Biological Fouling of Purified Water Systems, Part 1", Microcontamination 3(10). pp. 51-55, 70.

Mittleman, M.W. and Geesey, G.G., (1987)."Chapter 10: Sampling and Enumeration of Fouling Organisms", Biological Fouling of Industrial Water Systems: A Problem Solving Approach, Mittleman, M.W.; Geesey, G.G. Eds., Water Micro Associates, Long Bevac'h, CA.

Nebel C. and Nebel, T., (1984). "Ozone: The Process Water Sterilant"', Pharmaceutical Manufacturing 1(2), pp. 16-22.