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Cleanable Liquids Processing Equipment and Systems 245 3 CIPR 3 1 From buffer prep fill/CIPS VG 2 Buffer 4 Buffer 2 Buffer 3 Buffer 1 3 1,2 3 1,2,3 To buffer prep CIPR CIPRP1 CWFI 3 From purification CIPS 3 3 1M M #1 Train #2 Train M Product hold tank Column CIP by-pass Column feed FIGURE 8 Apartial extraction of the process schematic illustrates how Circuit 3flow of flush, wash, and rinse solutions was sequenced through the piping and the vessel. Sample To purification CIPR CIPRP2
246 CIP supply- 2" CIP return- 2" 1,2,3,4 2 Pulse upper seat to leak port 1,2,3,4 TK1 1 Mixproof valve with seat lifter T CS CIP flush line Pulse lower seat to leak port CS CS 4 3 3 TK2 FIGURE 9 Rising stem mixproof valves, applied three-per-vessel, provide automated control of all product and CIP fluids and isolation of all fluid streams. Aprocess requiring recycle to the source vessel would require afourth mixproof valve. The solid and dashed lines and numbered arrow heads define the CIP sub-circuits described in the narrative. CIP supply- 2" Bleed valve open CIP return- 2" T 1,2,3,4 Pulse bleed valve 1,2,3,4 2 TK1 T 1 3 3 CS Pulse bleed valve CIP flush line Bleed open valve 4 T TK2 T 4 Seiberling FIGURE 10 Diaphragm valves in valve assemblies can be applied to isolate product and CIP fluids and provide the identical operating capability of Figure 1or9.The solid and dashed lines and numbered arrow heads define the CIP sub-circuits described in the narrative. T 4
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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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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 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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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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170 (A) (B) Franks and Seiberling F
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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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Page 232 and 233: 12 Cleanable In-Line Components INT
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Page 240 and 241: Cleanable In-Line Components 219 FI
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Page 250 and 251: Cleanable In-Line Components 229 eq
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Page 256 and 257: 13 Cleanable Liquids Processing Equ
Page 258 and 259: Cleanable Liquids Processing Equipm
Page 268 and 269: 1-9 CIPS 2 Plant steam CIPS valves
Page 276: Cleanable Liquids Processing Equipm
Page 279 and 280: 258 8. Projectile-type thermometer
Page 281 and 282: 260 Forder control of the drying pr
Page 283 and 284: 262 Forder FIGURE 5 Pharmaceutical
Page 285 and 286: 264 Forder FIGURE 7 Pharmaceutical
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
Page 293 and 294: 272 FIGURE 17 Sanitary Vbenders. So
Page 295 and 296: 274 one each for the upper, central
Page 297 and 298: 276 CIP VS. TRADITIONAL BOIL-UP MET
Page 299 and 300: 278 Cerulli were not designed to be
Page 301 and 302: 280 by large flanged connections fo
Page 303 and 304: 282 CIP header Once thru CIP soluti
Page 305 and 306: 284 Nozzle Use A Manway B Agitator
Page 307 and 308: 286 3" Stub end w/150# flange 2A 1
Page 309 and 310: 288 In most cases, the pressure dro
Page 311 and 312: 290 CIP fluids Process fluids 1 2 3
Page 313 and 314: 292 A Vent to atm. B M Conical drye
Page 315 and 316: 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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17 Waste Treatment for the CIP Syst
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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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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
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