- Page 2 and 3: Filtration and Purification in the
- Page 4 and 5: 1. Pharmacokinetics, Milo Gibaldi a
- Page 6 and 7: 55. Radiopharmaceuticals: Chemistry
- Page 8 and 9: 107. Drug Stability: Principles and
- Page 10: 156. Pharmacogenomics: Second Editi
- Page 13: Informa Healthcare USA, Inc. 52 Van
- Page 18: Foreword Filtration has been used s
- Page 21 and 22: viii Preface describing essential p
- Page 23 and 24: x Contents 14. Extractables and Lea
- Page 25 and 26: xii Contributors Theodore H. Meltze
- Page 27: 2 Quigley liquids. The problem can
- Page 31 and 32: 6 Quigley This inertial force depen
- Page 33 and 34: 8 Quigley Adsorption Activated Carb
- Page 35 and 36: 10 Quigley easier to change than a
- Page 37 and 38: 12 Quigley The graded pore size for
- Page 39 and 40: 14 Quigley FIGURE 15 Depth and memb
- Page 41 and 42: 16 Quigley The proper cake formatio
- Page 43 and 44: 18 Quigley The sterile bulk albumin
- Page 45 and 46: 20 Quigley When running a forward f
- Page 48 and 49: 2 Charge Modified Filter Media Euge
- Page 50 and 51: Charge Modified Filter Media 25 pro
- Page 52 and 53: Charge Modified Filter Media 27 saf
- Page 54 and 55: Charge Modified Filter Media 29 FIG
- Page 56 and 57: Charge Modified Filter Media 31 FIG
- Page 58 and 59: Charge Modified Filter Media 33 FIG
- Page 60 and 61: Charge Modified Filter Media 35 At
- Page 62 and 63: Charge Modified Filter Media 37 FIG
- Page 64 and 65: Charge Modified Filter Media 39 FIG
- Page 66 and 67: Charge Modified Filter Media 41 FIG
- Page 68 and 69: Charge Modified Filter Media 43 DNA
- Page 70 and 71: Charge Modified Filter Media 45 Hag
- Page 72 and 73: 3 Filter Designs Suraj B. Baloda Mi
- Page 74 and 75: Filter Designs 49 The most common 4
- Page 76 and 77: 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 75 FIG
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Pore Sizes and Distributions 77 FIG
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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
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140 Meltzer and Jornitz Interesting
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142 Meltzer and Jornitz the endotox
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144 Meltzer and Jornitz (1) The equ
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146 Meltzer and Jornitz Bowman FW,
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148 Meltzer and Jornitz Ridgway HF.
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6 Microbiological Considerations in
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Microbiological Considerations 153
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Microbiological Considerations 155
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Microbiological Considerations 157
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Microbiological Considerations 159
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Microbiological Considerations 161
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164 Meltzer and Jornitz some lower
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166 Meltzer and Jornitz taken that
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168 Meltzer and Jornitz 8. Initial
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170 Meltzer and Jornitz flow decrea
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172 Meltzer and Jornitz FIGURE 3 Pa
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174 Meltzer and Jornitz FIGURE 5 Se
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176 Meltzer and Jornitz Homogeneous
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178 Meltzer and Jornitz Prefilter A
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180 Meltzer and Jornitz upon the us
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182 Meltzer and Jornitz obtained by
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184 Meltzer and Jornitz published.
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186 Meltzer and Jornitz If flow dec
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188 Meltzer and Jornitz effect, the
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190 Meltzer and Jornitz differentia
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192 Meltzer and Jornitz Trotter AM,
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194 Bardo We will survey key aspect
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196 Bardo corrosion cracking, inclu
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198 Bardo were to skip any of the m
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200 Bardo stainless steel and other
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202 Bardo all the obligations requi
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204 Bardo built into the top plate,
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206 Bardo often called domes or she
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208 Bardo FIGURE 3 T-style sanitary
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210 Bardo In multi-round sanitary h
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212 Bardo FIGURE 6 (A) 222- and (B)
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214 Bardo Cartridge replacement. St
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216 Bardo ever larger. As the bioph
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218 Bardo n Difficult to scale-up n
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220 Bardo that is free of many of t
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222 Bardo TABLE 3 Comparison of Sta
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224 Bardo From this productive amal
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226 Bardo n integrity testing, n va
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228 Bardo CONCLUSION The evolution
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9 Stainless Steel Application and F
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Stainless Steel Application and Fab
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Stainless Steel Application and Fab
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Stainless Steel Application and Fab
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Stainless Steel Application and Fab
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Stainless Steel Application and Fab
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Stainless Steel Application and Fab
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Stainless Steel Application and Fab
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Stainless Steel Application and Fab
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Stainless Steel Application and Fab
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Stainless Steel Application and Fab
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Stainless Steel Application and Fab
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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 319 FIGU
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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 331 the
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The Filter Integrity Tests 333 the
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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 343 FIGU
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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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Validation of the Filter and of the
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Validation of the Filter and of the
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Validation of the Filter and of the
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Validation of the Filter and of the
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Validation of the Filter and of the
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Validation of the Filter and of the
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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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Endotoxin, Limulus Amebocyte Lysate
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Endotoxin, Limulus Amebocyte Lysate
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Endotoxin, Limulus Amebocyte Lysate
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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
- Page 518:
Downstream Processing 493 Zhou JX,
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496 Dosmar and Pinto Pore size (mic
- Page 523 and 524:
498 Dosmar and Pinto Flux (ml/min/c
- Page 525 and 526:
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
- Page 535 and 536:
510 Dosmar and Pinto 0.4 0.3 0.2 0.
- Page 537 and 538:
512 Dosmar and Pinto Flux (mL/min/c
- Page 539 and 540:
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
- Page 587 and 588:
562 Aranha the virus, it cannot be
- Page 589 and 590:
564 Aranha Steps that require dilut
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566 Aranha TABLE 10 Categorization
- Page 593 and 594:
568 Aranha TABLE 12 Main Characteri
- Page 595 and 596:
570 Aranha rederivatization. CBER h
- Page 597 and 598:
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,
- Page 604 and 605:
21 A Rapid Method for Purifying Esc
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A Rapid Method for Purifying Escher
- Page 608 and 609:
A Rapid Method for Purifying Escher
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A Rapid Method for Purifying Escher
- Page 612 and 613:
A Rapid Method for Purifying Escher
- Page 614 and 615:
A Rapid Method for Purifying Escher
- Page 616 and 617:
A Rapid Method for Purifying Escher
- Page 618 and 619:
A Rapid Method for Purifying Escher
- Page 620 and 621:
A Rapid Method for Purifying Escher
- Page 622 and 623:
22 Membrane Chromatography Jeffrey
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Membrane Chromatography 599 contami
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Membrane Chromatography 601 the cyl
- Page 628 and 629:
Membrane Chromatography 603 Even so
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Membrane Chromatography 605 TABLE 2
- Page 632 and 633:
Membrane Chromatography 607 TABLE 4
- Page 634 and 635:
Membrane Chromatography 609 Isoelec
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Membrane Chromatography 611 validat
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Membrane Chromatography 613 C/CO 1
- Page 640 and 641:
Membrane Chromatography 615 TABLE 6
- Page 642 and 643:
Membrane Chromatography 617 spiked
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23 Expanded Polytetrafluoroethylene
- Page 646 and 647:
Expanded Polytetrafluoroethylene Me
- Page 648 and 649:
Expanded Polytetrafluoroethylene Me
- Page 650 and 651:
Expanded Polytetrafluoroethylene Me
- Page 652 and 653:
Expanded Polytetrafluoroethylene Me
- Page 654 and 655:
Expanded Polytetrafluoroethylene Me
- Page 656 and 657:
Expanded Polytetrafluoroethylene Me
- Page 658 and 659:
Expanded Polytetrafluoroethylene Me
- Page 660 and 661:
Expanded Polytetrafluoroethylene Me
- Page 662 and 663:
Expanded Polytetrafluoroethylene Me
- Page 664 and 665:
Expanded Polytetrafluoroethylene Me
- Page 666 and 667:
24 Air Filtration Applications in t
- Page 668 and 669:
Air Filtration Applications in the
- Page 670 and 671:
Air Filtration Applications in the
- Page 672 and 673:
Air Filtration Applications in the
- Page 674 and 675:
Air Filtration Applications in the
- Page 676 and 677:
Air Filtration Applications in the
- Page 678 and 679:
Air Filtration Applications in the
- Page 680 and 681:
Air Filtration Applications in the
- Page 682 and 683:
Air Filtration Applications in the
- Page 684 and 685:
Air Filtration Applications in the
- Page 686 and 687:
Air Filtration Applications in the
- Page 688 and 689:
Air Filtration Applications in the
- Page 690 and 691:
Air Filtration Applications in the
- Page 692 and 693:
Air Filtration Applications in the
- Page 694 and 695:
Air Filtration Applications in the
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Air Filtration Applications in the
- Page 698 and 699:
Air Filtration Applications in the
- Page 700 and 701:
Air Filtration Applications in the
- Page 702 and 703:
Air Filtration Applications in the
- Page 704 and 705:
Air Filtration Applications in the
- Page 706 and 707:
25 Sterility Testing by Filtration
- Page 708 and 709:
Sterility Testing by Filtration in
- Page 710 and 711:
Sterility Testing by Filtration in
- Page 712 and 713:
Sterility Testing by Filtration in
- Page 714 and 715:
Sterility Testing by Filtration in
- Page 716 and 717:
Sterility Testing by Filtration in
- Page 718 and 719:
Sterility Testing by Filtration in
- Page 720 and 721:
Sterility Testing by Filtration in
- Page 722:
Sterility Testing by Filtration in
- Page 725 and 726:
700 Mittelman phospholipids surroun
- Page 727 and 728:
702 Mittelman 1. Trace organics, wh
- Page 729 and 730:
704 Mittelman from chemical treatme
- Page 731 and 732:
706 Mittelman Flow Effects In the s
- Page 733 and 734:
708 Mittelman TREATMENT Inactivatio
- Page 735 and 736:
710 Mittelman TABLE 3 Chemical Trea
- Page 737 and 738:
712 Mittelman Khoury AE, Lam K, Ell
- Page 739 and 740:
714 Mittelman Richards GK, Gagnon R
- Page 742 and 743:
27 Steam Sterilization of Filters S
- Page 744 and 745:
Steam Sterilization of Filters 719
- Page 746 and 747:
Steam Sterilization of Filters 721
- Page 748 and 749:
Steam Sterilization of Filters 723
- Page 750 and 751:
Steam Sterilization of Filters 725
- Page 752 and 753:
Steam Sterilization of Filters 727
- Page 754 and 755:
Steam Sterilization of Filters 729
- Page 756 and 757:
Steam Sterilization of Filters 731
- Page 758 and 759:
Steam Sterilization of Filters 733
- Page 760 and 761:
Steam Sterilization of Filters 735
- Page 762 and 763:
Steam Sterilization of Filters 737
- Page 764 and 765:
Steam Sterilization of Filters 739
- Page 766 and 767:
Steam Sterilization of Filters 741
- Page 768 and 769:
Steam Sterilization of Filters 743
- Page 770 and 771:
Steam Sterilization of Filters 745
- Page 772 and 773:
Steam Sterilization of Filters 747
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Steam Sterilization of Filters 749
- Page 776:
Steam Sterilization of Filters 751
- Page 779 and 780:
754 Manfredi TABLE 1 List of Organo
- Page 781 and 782:
756 Manfredi Based upon its unstabl
- Page 783 and 784:
758 Manfredi Ozone, unlike chlorine
- Page 785 and 786:
760 Manfredi FIGURE 3 Tubular coron
- Page 787 and 788:
762 Manfredi Ozone monitors, for bo
- Page 789 and 790:
764 Manfredi ultraviolet decomposit
- Page 791 and 792:
766 Manfredi entering the vessel ma
- Page 793 and 794:
768 Manfredi d[O 3] = dt k o3 [M] [
- Page 795 and 796:
770 Manfredi pressure, although the
- Page 797 and 798:
772 Manfredi Ozone. 9 September 200
- Page 799 and 800:
774 Index [Air filtration applicati
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776 Index [Charge-modified filters]
- Page 803 and 804:
778 Index [ePTFE] lyophilization, 6
- Page 805 and 806:
780 Index [Filter validation/filter
- Page 807 and 808:
782 Index [Integrity tests] redunda
- Page 809 and 810:
784 Index Optimum TMP, definition,
- Page 811 and 812:
786 Index [Product capture/purifica
- Page 813 and 814:
788 Index [Steam sterilization of f
- Page 815:
790 Index Wetted membrane, rate of