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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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- Page 25 and 26: 4 Seiberling The vessel capacity ma
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- Page 31 and 32: 10 Seiberling program, and through
- Page 33 and 34: 12 Seiberling (380 L) for the solut
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- Page 37 and 38: 16 Seiberling products in asingle f
- Page 39 and 40: 18 Seiberling The literature began
- Page 42 and 43: 2 Project Planning for the CIPable
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- Page 62 and 63: 3 Water for the CIP System Jay C. A
- Page 64 and 65: Water for the CIP System 43 FIGURE
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- Page 68 and 69: Water for the CIP System 47 FIGURE
- Page 70 and 71: Water for the CIP System 49 FIGURE
- Page 72: Water for the CIP System 51 WATER U
- Page 77 and 78: 56 Classification of Cleaners by pH
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- Page 81 and 82: 60 + - Na O O C CH 2 CH 2 (CH 2 ) n
- Page 83 and 84: 62 CH3 -(CH2 ) n -CH2 -O -CH2 -CH2
- Page 85 and 86: 64 B C D E FIGURE 17 Capability of
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- Page 91 and 92: 70 desorption. If the affinity is v
- Page 93 and 94: 72 & Cleaning procedure inthe case
- Page 95 and 96: 74 effort being performed relativel
- Page 97 and 98: 76 Rush & A1000 Lmixing vessel, hav
- Page 99 and 100: 78 TABLE 2 Typical Single-Pass Chem
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- Page 103 and 104: 82 Rush Intermediate Drain Objectiv
- Page 105 and 106: 84 Rush Final Drain Phase (Gravity)
- Page 107 and 108: 86 TABLE 4 Recirculated Chemical Wa
- Page 109 and 110: 88 Rush type of soil include fermen
- Page 111 and 112: 90 The pre-cleaning process flush w
- Page 113 and 114: 92 REFERENCES Rush 1. Howard T, Wie
- Page 115 and 116: 94 CIP return (CIPR)-piping to conv
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- Page 119 and 120: 98 Single-Tank CIP Skid Operational
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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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Cleanable Liquids Processing Equipm
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1-9 CIPS 2 Plant steam CIPS valves
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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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258 8. Projectile-type thermometer
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260 Forder control of the drying pr
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262 Forder FIGURE 5 Pharmaceutical
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264 Forder FIGURE 7 Pharmaceutical
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266 FIGURE 9 Pleated filter cartrid
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268 FIGURE 12 Disassembledstainless
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270 The acid wash of 85% phosphoric
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272 FIGURE 17 Sanitary Vbenders. So
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274 one each for the upper, central
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276 CIP VS. TRADITIONAL BOIL-UP MET
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278 Cerulli were not designed to be
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280 by large flanged connections fo
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282 CIP header Once thru CIP soluti
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284 Nozzle Use A Manway B Agitator
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286 3" Stub end w/150# flange 2A 1
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288 In most cases, the pressure dro
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290 CIP fluids Process fluids 1 2 3
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292 A Vent to atm. B M Conical drye
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294 One of the designer’s first t
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16 CIP System Troubleshooting Guide
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CIP System Troubleshooting Guide 29
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CIP System Troubleshooting Guide 30
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CIP System Troubleshooting Guide 30
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CIP System Troubleshooting Guide 30
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CIP System Troubleshooting Guide 30
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CIP System Troubleshooting Guide 30
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CIP System Troubleshooting Guide 31
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CIP System Troubleshooting Guide 31
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17 Waste Treatment for the CIP Syst
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Waste Treatment for the CIP System
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Waste Treatment for the CIP System
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Waste Treatment for the CIP System
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Waste Treatment for the CIP System
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Waste Treatment for the CIP System
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18 Commissioning and Qualification
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Commissioning and Qualification 329
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Commissioning and Qualification 331
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Commissioning and Qualification 333
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Commissioning and Qualification 335
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Commissioning and Qualification 337
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Commissioning and Qualification 339
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Commissioning and Qualification 341
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Commissioning and Qualification 343
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Commissioning and Qualification 345
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348 & Sterilization refers to the r
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350 Lankford All analytical methods
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352 should be based upon scientific
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354 Lankford acleaning validation p
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356 In summary, TOC analysis is are
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358 In-Situ In-situ measurement tec
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360 15. Karen A. Clark, Product Man
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362 Actually, most countries revise
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364 §211.100 Written procedures; d
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366 §211.186 Master production and
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368 Equipment Regulation C.02.005 T
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370 … C.02.004 … 4. Pipework sy
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372 5.20 Schedules and procedures (
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374 TABLE 1 Directives of the Europ
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376 TABLE 5 Cleanability Performanc
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Index Accessibility, 28 Acid cleane
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Index 381 CIP supply flow troublesh
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Index 383 [Cleaning cycle sequences
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Index 385 Flow alarm, no-return, 30
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Index 387 Off skid instrumentation,
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Index 389 Rising stem valves, 223-2
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Index 391 [Troubleshooting] spray c