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Clean-In-Place for Biopharmaceutica
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Informa Healthcare USA, Inc. 52 Van
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iv Preface period, the industry rec
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Preface iii Contents Acknowledgment
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Contributors Barry J. Andersen Seib
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2 the last step of abatch manufactu
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4 Seiberling The vessel capacity ma
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6 Seiberling any two ports. For pur
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8 AWFI (or Any Water) Supply If the
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10 Seiberling program, and through
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12 Seiberling (380 L) for the solut
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14 AWFI CIP skid Drain When steam a
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16 Seiberling products in asingle f
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18 Seiberling The literature began
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2 Project Planning for the CIPable
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Project Planning for CIPable Facili
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Project Planning for CIPable Facili
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Project Planning for CIPable Facili
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Project Planning for CIPable Facili
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Project Planning for CIPable Facili
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Project Planning for CIPable Facili
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Project Planning for CIPable Facili
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Project Planning for CIPable Facili
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Project Planning for CIPable Facili
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3 Water for the CIP System Jay C. A
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Water for the CIP System 43 FIGURE
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Water for the CIP System 45 of clea
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Water for the CIP System 47 FIGURE
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Water for the CIP System 49 FIGURE
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Water for the CIP System 51 WATER U
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54 Time Temperature FIGURE 2 The cl
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56 Classification of Cleaners by pH
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58 [mg/sec] Cleaning velocity C v ,
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60 + - Na O O C CH 2 CH 2 (CH 2 ) n
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62 CH3 -(CH2 ) n -CH2 -O -CH2 -CH2
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64 B C D E FIGURE 17 Capability of
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66 pH 13 pH 7 pH, %, Excess water h
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68 dramatically increased rinsing t
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70 desorption. If the affinity is v
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72 & Cleaning procedure inthe case
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74 effort being performed relativel
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76 Rush & A1000 Lmixing vessel, hav
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78 TABLE 2 Typical Single-Pass Chem
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80 Rush Rinse Volume (Duration) The
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82 Rush Intermediate Drain Objectiv
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84 Rush Final Drain Phase (Gravity)
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86 TABLE 4 Recirculated Chemical Wa
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88 Rush type of soil include fermen
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90 The pre-cleaning process flush w
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92 REFERENCES Rush 1. Howard T, Wie
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94 CIP return (CIPR)-piping to conv
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96 Seiberling provided, generally o
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98 Single-Tank CIP Skid Operational
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100 Single-Tank Bypass or Recycle O
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102 Seiberling Single-Tank Single P
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104 Seiberling installation of an e
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106 Chemical loop AB FE Chemical bl
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108 Chemical loop AB FCV FE Steam C
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CIP supply Transfer line (typical)
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112 Seiberling FIGURE 14 This singl
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114 Seiberling FIGURE 15 This large
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116 Seiberling FIGURE 17 This mini-
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7 CIP System Instrumentation and Co
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CIP System Instrumentation and Cont
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CIP System Instrumentation and Cont
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CIP System Instrumentation and Cont
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CIP System Instrumentation and Cont
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CIP System Instrumentation and Cont
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CIP System Instrumentation and Cont
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CIP System Instrumentation and Cont
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CIP System Instrumentation and Cont
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CIP System Instrumentation and Cont
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CIP System Instrumentation and Cont
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CIP System Instrumentation and Cont
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CIP System Instrumentation and Cont
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146 Lebowitz should be considered f
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148 Lebowitz barrels and the chemic
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150 Lebowitz Electromagnetic-Operat
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152 Lebowitz FIGURE 5 The venturi o
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154 Chemical pump enclosure Acid AL
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156 Steam Facility acid header Faci
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158 Lebowitz That is to say aweak a
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160 CIP Philosophy The production p
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162 Franks and Seiberling the numbe
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164 Franks and Seiberling Similar s
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166 Franks and Seiberling FIGURE 3
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168 Franks and Seiberling FIGURE 5
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170 (A) (B) Franks and Seiberling F
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172 Franks and Seiberling FIGURE 9
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174 The variables that impact the r
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176 There are two guiding concepts
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178 Mezz. Floor(ref.) V-5 1000L CIP
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180 return line piping, substantial
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182 Lebowitz U-bend transfer panels
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184 Lebowitz oriented vertically. T
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186 Lebowitz suction-side port on T
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CIPS loop Primary CIPS CIPSPS CIPS
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190 Lebowitz FIGURE 10 Photo of sma
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192 Drain CIP return Drain Recycle
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11 Materials of Construction and Su
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Materials of Construction and Surfa
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Materials of Construction and Surfa
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Materials of Construction and Surfa
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Materials of Construction and Surfa
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Materials of Construction and Surfa
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Materials of Construction and Surfa
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Materials of Construction and Surfa
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12 Cleanable In-Line Components INT
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Cleanable In-Line Components 213 &
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Cleanable In-Line Components 215 Al
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Cleanable In-Line Components 217 Ex
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Cleanable In-Line Components 219 FI
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Cleanable In-Line Components 221 Tr
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Cleanable In-Line Components 223 it
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Cleanable In-Line Components 225 FI
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Cleanable In-Line Components 227 FI
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Cleanable In-Line Components 229 eq
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Cleanable In-Line Components 231 Th
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Cleanable In-Line Components 233 co
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13 Cleanable Liquids Processing Equ
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Cleanable Liquids Processing Equipm
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Cleanable Liquids Processing Equipm
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Cleanable Liquids Processing Equipm
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Cleanable Liquids Processing Equipm
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- Page 279 and 280: 258 8. Projectile-type thermometer
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- Page 287 and 288: 266 FIGURE 9 Pleated filter cartrid
- Page 289 and 290: 268 FIGURE 12 Disassembledstainless
- Page 291 and 292: 270 The acid wash of 85% phosphoric
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- Page 309 and 310: 288 In most cases, the pressure dro
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- Page 357 and 358: 336 Norton Understand the Software
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19 Cleaning Validation Strategies C
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Cleaning Validation Strategies 349
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Cleaning Validation Strategies 351
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Cleaning Validation Strategies 353
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Cleaning Validation Strategies 355
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Cleaning Validation Strategies 357
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Cleaning Validation Strategies 359
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20 International Regulations INTROD
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International Regulations 363 §211
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International Regulations 365 of th
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International Regulations 367 “
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International Regulations 369 Sanit
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International Regulations 371 guide
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International Regulations 373 The a
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International Regulations 375 TABLE
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International Regulations 377 6. Co
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380 Chemical storage and handling,
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382 [CIPable facility project plann
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384 [Design for cleaning] surface,
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386 International Society for Pharm
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388 Process controls, CIP system in
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390 [Spray cleaning] fixed devices,