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Commissioning and Qualification 331 CIPR from circuits TT AT Resistivity Waste LT FIGURE 2 Schematic of aCIP skid. 5CWater 65 CWater Spray balls CIP tank Vent filter Caustic CIPS to circuits CIP Supply pump AT AT Caustic 4. Solutions are pumped through the CIP supply piping with asupply pump. Return flow is via gravity or areturn pump. 5. Cleaning of the process equipment is via stationary spray balls. Product contacting piping will be cleaned via appropriate cleaning velocity through the piping. 6. Cleaning cycles are: water prerinse, alkaline wash, water post-rinse, acid wash, final water rinse. 7. Water rinses are once through followed by a short drain of the process equipment and return piping. 8. The alkaline wash and acid wash are circulated via the CIP skid solution tank, and are followed by an air blow of the supply piping, drainage of the complete CIP circuit, and awater rinse of the CIP tank. 9. During each cleaning cycle and air blow, fluids are passed through the CIP circuit in arepetitive pattern. The wash sequence is called the normal device sequence (NDS). The air blow is in accord with an air blow sequence (ABS). Device Sequences Asimplified NDS can be found in Table 1. The ABS sequence looks similar but is normally less complicated than the NDS. These sequences are prepared for each CIP circuit. Sequence steps are similar for similar process equipment. However,step times and specific valve and equipment identities will vary for each circuit. The sequencing of the CIP skid program must be equally well understood. The CIP skid prepares the solution required for various CIP cycles to be delivered to Acid Steam PT Conductivity Heat exchanger VFD Acid TT FCV FT
332 TABLE 1 Normal Device Sequence Tag no. Description Spray ball Dip tube Sample valve Transition Transfer line Transition Step time seconds 60 10 10 1 35 1 Sequenced valves FV-AA Spray ball supply O O O O C O FV-AB Process dip tube CIP supply C O C C C C FV-AC Sample CIP supply C C O C C C FV-AD Tank bottom valve O O O O C O FV-AE Tank AtoBtransfer CIP supply C C C O O O Maintained open valves FV-AS Tank-A top manifold feed to tank-A valve O O O O O O FV-AR Tank-A bottom manifold CIP return valve O O O O O O FV-SA CIPS manifold tank ACIPS valve O O O O O O FV-SB CIPS manifold tank BCIPS valve O O O O O O Maintained closed valves FV-BS Tank-B top manifold feed to tank-B valve C C C C C C Abbreviations: CIP, clean-in-place; CIPS, clean-in-place supply. Norton
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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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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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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
Page 318 and 319: 16 CIP System Troubleshooting Guide
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Page 371 and 372: 350 Lankford All analytical methods
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Page 375 and 376: 354 Lankford acleaning validation p
Page 377 and 378: 356 In summary, TOC analysis is are
Page 379 and 380: 358 In-Situ In-situ measurement tec
Page 381 and 382: 360 15. Karen A. Clark, Product Man
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Page 389 and 390: 368 Equipment Regulation C.02.005 T
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Page 393 and 394: 372 5.20 Schedules and procedures (
Page 395 and 396: 374 TABLE 1 Directives of the Europ
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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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