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Preface iii Contents Acknowledgments v Contributors ix 1. Introduction and Historical Development 1 Dale A. Seiberling 2. Project Planning for the CIPable Pharmaceutical or Biopharmaceutical Facility 21 Johannes R. Roebers and Dale A. Seiberling 3. Water for the CIP System 41 Jay C. Ankers 4. The Composition of Cleaning Agents for the Pharmaceutical Industries 53 Dietmar Rosner 5. Cleaning Cycle Sequences 73 Sally J. Rush 6. CIP System Components and Configurations 93 Dale A. Seiberling 7. CIP System Instrumentation and Controls 119 Barry J. Andersen 8. Cleaning Agent Injection Systems 145 Samuel F. Lebowitz 9. CIP Spray Device Design and Application 159 John W. Franks and Dale A. Seiberling 10. CIP Distribution Piping Systems 175 Samuel F. Lebowitz 11. Materials of Construction and Surface Finishes 195 David M. Greene 12. Cleanable In-Line Components 211 Lyle W. Clem 13. Cleanable Liquids Processing Equipment and Systems 235 Dale A. Seiberling vii
viii 14. Cleanable Solids Processing Equipment and Systems 257 Simon E.J. Forder 15. Cleanable API Processing Equipment and Systems 275 Gerald J. Cerulli 16. CIP System Troubleshooting Guide 297 Sally J. Rush 17. Waste Treatment for the CIP System 315 Linda Rauch and Jay C. Ankers 18. Commissioning and Qualification 327 James P. Norton 19. Cleaning Validation Strategies 347 Charles Lankford 20. International Regulations 361 Albrecht Killinger and Joachim Höller Index 379 Contents
Page 2: Clean-In-Place for Biopharmaceutica
Page 13 and 14: Informa Healthcare USA, Inc. 52 Van
Page 15 and 16: iv Preface period, the industry rec
Page 20: Contributors Barry J. Andersen Seib
Page 23 and 24: 2 the last step of abatch manufactu
Page 25 and 26: 4 Seiberling The vessel capacity ma
Page 27 and 28: 6 Seiberling any two ports. For pur
Page 29 and 30: 8 AWFI (or Any Water) Supply If the
Page 31 and 32: 10 Seiberling program, and through
Page 33 and 34: 12 Seiberling (380 L) for the solut
Page 35 and 36: 14 AWFI CIP skid Drain When steam a
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
Page 44 and 45: Project Planning for CIPable Facili
Page 62 and 63: 3 Water for the CIP System Jay C. A
Page 64 and 65: Water for the CIP System 43 FIGURE
Page 66 and 67: 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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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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11 Materials of Construction and Su
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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 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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1-9 CIPS 2 Plant steam CIPS valves
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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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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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