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Filter Sizing: The Requirements and Their Attainment 191 between the fluid and the filter media. Flow decays can be performed quickly and easily in “indicator trials” in a matter of hours using small disc filters, whereas foregoing their option may require experimentation with process filters for days or weeks. “Verification trials” should follow to more quantitatively confirm the results gained from using 47-mm disc filters. It is from the “verification trials” with small pleated devices that the flow modifications introduced by cartridge constructions can be evaluated and allowed for. The results forthcoming from the more focused “verification trials” are then extrapolated to the full scale pleated cartridges needed to accommodate full productions. The completion of this series of preliminary flow decay evaluations, designed to progressively and realistically address production requirements, will provide fairly accurate data leading to the choice of proper prefilter/final filter combinations in the appropriate ratio of their filter areas. REFERENCES Aicholtz P, Wilkins R, Gabler R. Sterile filtration under conditions of high pressure and bacterial challenge levels. J Parenteral Drug Assoc 1987; 41:117–20. CPMP–EMEA. Note for Guidance in Manufacture of the Finished Dosage Form; 1996; April. FDA. Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing – CGMP. Rockville, MD: Center for Drugs and Biologics and Office of Regulatory Affairs, Food and Drug Administration; 1987, 2002. FDA. CDER Guidelines on Sterile Drug Products by Asceptic Processing. 21 CFR Part 10.90; 1987:28. HIMA. Microbial Evaluation of Filters for Sterilizing Liquids, Document No. 3, Vol. 4. Washington, D.C.: Health Industry Manufacturers Association; 1982. Green H, Meltzer TH. Flow & pressure, filter sizing and filter system design. In: Meltzer TH, ed. Filtration in the Pharmaceutical Industry. New York: Marcel Dekker; 1987: Chap. 10. Green H, Scheer LA. Sizing microporous membrane filter systems. In: Meltzer TH, Jornitz MW, eds. Filtration in the Biopharmaceutical Industry. New York: Marcel Dekker; 1998; Chap 12. Johnston PR. Liquid flow through a single tube. In: Fluid Sterilisation by Filtration. Buffalo Grove, IL: Interpharm Press;1992: 29. Johnston PR. Capacity of a Filter Medium in Constant-Pressure Filtration. Fluid Sterilisation by Filtration, 3rd Ed., Boca Raton, FL: Interpharm/CDC;2003. Jornitz TH, Meltzer TH. Sterile filtration: A practical approach. In: Flow Decay, Filter Sizing. New York: Marcel Dekker; 2001: Chap 4. Jornitz MW, Meltzer TH, Lindenblatt J. The filtration debate. Pharm Formulation Quality 2004; May:89–93. Jornitz MW, Meltzer TH, Bromm H, Priebe PM. Testing for the optimal filter membrane, required prerequisites. Genetic Eng News 2004; 24(13):89–93. Leahy TJ; Sullivan MJ. Validation of bacterial retention capabilities of membrane filters. Pharm Technol 1978; 2(11):64–75. Meltzer TH, Lindenblatt J. Selecting 0.1 or 0.2/0.22-rated filters: Consideration of rates of flow. Eur J Parenteral Sci 2002; 7(4):111–14. Priebe PM, Jornitz MW, Meltzer TH. Making an informed membrane filter choice. Bioprocess Int 2003; October: 64–6. Reti AR, Leahy TJ, Meier PM. The retention mechanism of sterilizing and other submicron high efficiency filter structures. Proceedings of the Second World Filtration Congress, London, U.K.; 1979: 427–36. Tanny GB, Strong DK, Presswood WG, Meltzer TH. The adsorptive retention of Pseudomonas diminuta by membrane filters. J Parenteral Drug Assoc 1979; 33(l):40–51.
192 Meltzer and Jornitz Trotter AM, Meltzer TH, Feng Bai, Thoma LA. Integrity test measurements – effects of bacterial cell loadings. Pharm Technol 2000; 24(3):72–80. Trotter AM, Rodriguez PJ, Thoma LA. The usefulness of 0.45 mm-rated filter membranes. Pharm Technol 2002; 26(4):60–71. Wrasidlo W, Mysels KJ. The structure and some properties of graded highly asymmetric porous membranes. J Parenteral Sci Technol 1984; 38(l):24–31.
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Filtration and Purification in the
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1. Pharmacokinetics, Milo Gibaldi a
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55. Radiopharmaceuticals: Chemistry
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107. Drug Stability: Principles and
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156. Pharmacogenomics: Second Editi
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Informa Healthcare USA, Inc. 52 Van
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Foreword Filtration has been used s
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viii Preface describing essential p
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x Contents 14. Extractables and Lea
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xii Contributors Theodore H. Meltze
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2 Quigley liquids. The problem can
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4 Quigley FIGURE 3 Diatoms in diato
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6 Quigley This inertial force depen
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8 Quigley Adsorption Activated Carb
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10 Quigley easier to change than a
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12 Quigley The graded pore size for
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14 Quigley FIGURE 15 Depth and memb
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16 Quigley The proper cake formatio
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18 Quigley The sterile bulk albumin
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20 Quigley When running a forward f
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2 Charge Modified Filter Media Euge
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Charge Modified Filter Media 25 pro
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Charge Modified Filter Media 27 saf
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Charge Modified Filter Media 29 FIG
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Charge Modified Filter Media 35 At
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Charge Modified Filter Media 43 DNA
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Charge Modified Filter Media 45 Hag
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3 Filter Designs Suraj B. Baloda Mi
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Filter Designs 49 The most common 4
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Filter Designs 51 Multiple steps an
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Filter Designs 53 air filtration or
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Filter Designs 55 pleat pack that c
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Filter Designs 57 FIGURE 7 Differen
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Filter Designs 59 the tailoring of
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Filter Designs 61 measured. This gi
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Filter Designs 63 FIGURE 12 (A) Pil
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4 Pore Sizes and Distributions C. T
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Pore Sizes and Distributions 67 Fil
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Pore Sizes and Distributions 69 FIG
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Pore Sizes and Distributions 71 pre
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Pore Sizes and Distributions 73 whe
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Pore Sizes and Distributions 79 fil
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82 Meltzer and Jornitz The pore str
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84 Meltzer and Jornitz Pore Size Di
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86 Meltzer and Jornitz The dilution
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88 Meltzer and Jornitz per cm 2 EFA
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90 Meltzer and Jornitz TABLE 2 Rete
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92 Meltzer and Jornitz FIGURE 9 B.
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94 Meltzer and Jornitz Viscosity Vi
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96 Meltzer and Jornitz TABLE 5 Rete
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98 Meltzer and Jornitz fluid in its
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100 Meltzer and Jornitz TABLE 7 Flu
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102 Meltzer and Jornitz THE MODELIN
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104 Meltzer and Jornitz FIGURE 12 P
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106 Meltzer and Jornitz the mechani
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108 Meltzer and Jornitz filters in
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110 Meltzer and Jornitz particles f
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112 Meltzer and Jornitz from the el
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114 Meltzer and Jornitz modified to
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116 Meltzer and Jornitz This finds
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118 Meltzer and Jornitz The hydroge
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120 Meltzer and Jornitz Solvating E
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122 Meltzer and Jornitz filter’s
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124 Meltzer and Jornitz bonding of
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126 Meltzer and Jornitz and strongl
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128 Meltzer and Jornitz bacteria ne
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130 Meltzer and Jornitz The Electri
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132 Meltzer and Jornitz namely VDW
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134 Meltzer and Jornitz (non-flowin
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136 Meltzer and Jornitz hydrocarbon
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138 Meltzer and Jornitz neutralized
Page 165 and 166: 140 Meltzer and Jornitz Interesting
Page 167 and 168: 142 Meltzer and Jornitz the endotox
Page 169 and 170: 144 Meltzer and Jornitz (1) The equ
Page 171 and 172: 146 Meltzer and Jornitz Bowman FW,
Page 173 and 174: 148 Meltzer and Jornitz Ridgway HF.
Page 176 and 177: 6 Microbiological Considerations in
Page 178 and 179: Microbiological Considerations 153
Page 186: Microbiological Considerations 161
Page 189 and 190: 164 Meltzer and Jornitz some lower
Page 191 and 192: 166 Meltzer and Jornitz taken that
Page 193 and 194: 168 Meltzer and Jornitz 8. Initial
Page 195 and 196: 170 Meltzer and Jornitz flow decrea
Page 197 and 198: 172 Meltzer and Jornitz FIGURE 3 Pa
Page 199 and 200: 174 Meltzer and Jornitz FIGURE 5 Se
Page 201 and 202: 176 Meltzer and Jornitz Homogeneous
Page 203 and 204: 178 Meltzer and Jornitz Prefilter A
Page 205 and 206: 180 Meltzer and Jornitz upon the us
Page 207 and 208: 182 Meltzer and Jornitz obtained by
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Page 211 and 212: 186 Meltzer and Jornitz If flow dec
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Page 219 and 220: 194 Bardo We will survey key aspect
Page 221 and 222: 196 Bardo corrosion cracking, inclu
Page 223 and 224: 198 Bardo were to skip any of the m
Page 225 and 226: 200 Bardo stainless steel and other
Page 227 and 228: 202 Bardo all the obligations requi
Page 229 and 230: 204 Bardo built into the top plate,
Page 231 and 232: 206 Bardo often called domes or she
Page 233 and 234: 208 Bardo FIGURE 3 T-style sanitary
Page 235 and 236: 210 Bardo In multi-round sanitary h
Page 237 and 238: 212 Bardo FIGURE 6 (A) 222- and (B)
Page 239 and 240: 214 Bardo Cartridge replacement. St
Page 241 and 242: 216 Bardo ever larger. As the bioph
Page 243 and 244: 218 Bardo n Difficult to scale-up n
Page 245 and 246: 220 Bardo that is free of many of t
Page 247 and 248: 222 Bardo TABLE 3 Comparison of Sta
Page 249 and 250: 224 Bardo From this productive amal
Page 251 and 252: 226 Bardo n integrity testing, n va
Page 253 and 254: 228 Bardo CONCLUSION The evolution
Page 256 and 257: 9 Stainless Steel Application and F
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Stainless Steel Application and Fab
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258 Meltzer operational mechanism (
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260 Meltzer adsorptive interactions
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262 Meltzer surfaces to which they
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264 Meltzer matter, the bovine seru
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266 Meltzer FIGURE 2 Outer coats of
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268 Meltzer molecular arrangements
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270 Meltzer Extents of adsorption d
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272 Meltzer Qualitative Measurement
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274 Meltzer albumin solution, etc.
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276 Meltzer hydrophobic bonding. An
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278 Meltzer network. Thus, the mole
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280 Meltzer FIGURE 8 The hydrogen b
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282 Meltzer TABLE 4 Flu-Vaccine Fil
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284 Meltzer feedstream. At this poi
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286 Meltzer FIGURE 10 Different pro
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288 Meltzer factors, the short rang
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290 Meltzer plotted trace signals b
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292 Meltzer instead of flat membran
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294 Meltzer Characklis WG. Microbia
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11 The Filter Integrity Tests Theod
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The Filter Integrity Tests 299 befo
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The Filter Integrity Tests 301 side
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The Filter Integrity Tests 303 the
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The Filter Integrity Tests 305 supe
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The Filter Integrity Tests 307 thes
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The Filter Integrity Tests 309 Data
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The Filter Integrity Tests 311 The
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The Filter Integrity Tests 313 FIGU
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The Filter Integrity Tests 315 may
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The Filter Integrity Tests 317 pres
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The Filter Integrity Tests 321 Due
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The Filter Integrity Tests 323 Log
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The Filter Integrity Tests 325 Pres
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The Filter Integrity Tests 327 filt
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The Filter Integrity Tests 329 are
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The Filter Integrity Tests 335 test
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The Filter Integrity Tests 337 Is t
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The Filter Integrity Tests 339 (Tro
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The Filter Integrity Tests 341 an i
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The Filter Integrity Tests 345 The
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The Filter Integrity Tests 347 EMEA
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The Filter Integrity Tests 349 Waib
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352 Jornitz For this reason vendors
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354 Jornitz Nevertheless, the vendo
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356 Jornitz meaning every step requ
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358 Jornitz successes will also ens
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360 Jornitz components are required
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362 Jornitz API WFI Higher Risk or
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364 Jornitz FIGURE 9 Typical flow d
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366 Jornitz is supplied to assure a
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368 Jornitz FIGURE 12 Validation sc
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13 Validation of the Filter and of
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Validation of the Filter and of the
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390 Colton and Bestwick FIGURE 1 Cr
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392 Colton and Bestwick such as pol
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394 Colton and Bestwick Filters use
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396 Colton and Bestwick 3. Composit
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398 Colton and Bestwick Another con
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400 Colton and Bestwick This experi
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402 Colton and Bestwick and leachab
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404 Colton and Bestwick The mass fr
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406 Colton and Bestwick through the
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408 Colton and Bestwick Alternative
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410 Colton and Bestwick Modeling Le
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15 Endotoxin, Limulus Amebocyte Lys
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Endotoxin, Limulus Amebocyte Lysate
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426 Gould thousand to roughly 25,00
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428 Gould different endotoxin prepa
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430 Gould Because turbidity can be
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432 Gould ERROR OF THE LAL TEST The
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434 Gould qualification of the LAL
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436 Gould promotes adsorption and d
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438 Gould Twohy CW, Nierman ML, Dur
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440 Jornitz and Meltzer form a high
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442 Jornitz and Meltzer Another imp
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444 Jornitz and Meltzer commonly sh
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446 Jornitz and Meltzer required to
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448 Jornitz and Meltzer FIGURE 10 F
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450 Jornitz and Meltzer filter devi
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452 Jornitz and Meltzer filter (600
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454 Jornitz and Meltzer FIGURE 15 F
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456 Jornitz and Meltzer the end use
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18 Downstream Processing Uwe Gottsc
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Downstream Processing 461 medium wi
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Downstream Processing 463 explore s
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Downstream Processing 465 (A) (B) S
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Downstream Processing 467 impuritie
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Downstream Processing 469 TABLE 1 D
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Downstream Processing 471 (A) (B) S
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Downstream Processing 473 n flux us
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Downstream Processing 475 Feed Resi
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Downstream Processing 477 TABLE 2 S
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Downstream Processing 479 Chromatog
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Downstream Processing 481 TABLE 3 S
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Downstream Processing 483 crystalli
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Downstream Processing 485 presents
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Downstream Processing 487 and react
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Downstream Processing 489 The chall
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Downstream Processing 491 Jagschies
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Downstream Processing 493 Zhou JX,
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496 Dosmar and Pinto Pore size (mic
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498 Dosmar and Pinto Flux (ml/min/c
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500 Dosmar and Pinto APPLICATIONS I
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502 Dosmar and Pinto In instances w
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504 Dosmar and Pinto TABLE 1 The Th
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506 Dosmar and Pinto 40% respective
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508 Dosmar and Pinto The polysulfon
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510 Dosmar and Pinto 0.4 0.3 0.2 0.
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512 Dosmar and Pinto Flux (mL/min/c
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514 Dosmar and Pinto interface. The
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516 Dosmar and Pinto Permeate port
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518 Dosmar and Pinto layer is on th
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520 Dosmar and Pinto TABLE 4 Factor
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522 Dosmar and Pinto If the tempera
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524 Dosmar and Pinto Excessive TMP
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526 Dosmar and Pinto Permeate Flow
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528 Dosmar and Pinto rate, identify
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530 Dosmar and Pinto shown) at any
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532 Dosmar and Pinto TABLE 6 Casset
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534 Dosmar and Pinto to the feed ta
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536 Dosmar and Pinto TABLE 8 Biolog
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538 Dosmar and Pinto TABLE Adsorpti
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540 Dosmar and Pinto MWCO Abbreviat
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542 Dosmar and Pinto Marshall AD, M
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544 Aranha were directed at selecti
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546 Aranha CONTROL OF PRODUCTION PR
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548 Aranha There are several availa
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550 Aranha TABLE 4 Risk Minimizatio
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552 Aranha proteins from chromatogr
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554 Aranha side of the filter is ta
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556 Aranha If the size of the prote
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558 Aranha Regulatory guidelines (C
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560 Aranha vary depending on the un
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562 Aranha the virus, it cannot be
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564 Aranha Steps that require dilut
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566 Aranha TABLE 10 Categorization
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568 Aranha TABLE 12 Main Characteri
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570 Aranha rederivatization. CBER h
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572 Aranha also virus removal filte
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574 Aranha every single reported ca
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576 Aranha Golker CF, Whiteman MD,
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21 A Rapid Method for Purifying Esc
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A Rapid Method for Purifying Escher
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22 Membrane Chromatography Jeffrey
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Membrane Chromatography 599 contami
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Membrane Chromatography 601 the cyl
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Membrane Chromatography 603 Even so
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Membrane Chromatography 605 TABLE 2
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Membrane Chromatography 609 Isoelec
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Membrane Chromatography 611 validat
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Membrane Chromatography 613 C/CO 1
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Membrane Chromatography 617 spiked
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23 Expanded Polytetrafluoroethylene
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Expanded Polytetrafluoroethylene Me
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24 Air Filtration Applications in t
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Air Filtration Applications in the
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25 Sterility Testing by Filtration
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Sterility Testing by Filtration in
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700 Mittelman phospholipids surroun
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702 Mittelman 1. Trace organics, wh
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704 Mittelman from chemical treatme
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706 Mittelman Flow Effects In the s
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708 Mittelman TREATMENT Inactivatio
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710 Mittelman TABLE 3 Chemical Trea
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712 Mittelman Khoury AE, Lam K, Ell
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714 Mittelman Richards GK, Gagnon R
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27 Steam Sterilization of Filters S
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Steam Sterilization of Filters 719
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754 Manfredi TABLE 1 List of Organo
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756 Manfredi Based upon its unstabl
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758 Manfredi Ozone, unlike chlorine
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760 Manfredi FIGURE 3 Tubular coron
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762 Manfredi Ozone monitors, for bo
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764 Manfredi ultraviolet decomposit
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766 Manfredi entering the vessel ma
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768 Manfredi d[O 3] = dt k o3 [M] [
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770 Manfredi pressure, although the
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772 Manfredi Ozone. 9 September 200
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774 Index [Air filtration applicati
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776 Index [Charge-modified filters]
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778 Index [ePTFE] lyophilization, 6
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780 Index [Filter validation/filter
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782 Index [Integrity tests] redunda
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784 Index Optimum TMP, definition,
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786 Index [Product capture/purifica
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788 Index [Steam sterilization of f
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790 Index Wetted membrane, rate of
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