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CIP System Troubleshooting Guide 313 and CIP operations should be examined to determine if the “hold dirty” time has been exceeded. If the dirty hold time is exceeded, it may take repeated executions of the CIP program toremove the dried on soil. Evaluate Spray Coverage Spray devices will be removed and reinstalled throughout the life of the facility, and if this operation is done by those unskilled in the process, one or more may be improperly positioned. The first field investigation is to ensure that there are no spray device installation or indexing errors, meaning the sprays destined for the vessel are properly installed in the correct nozzle and indexed according to its indexing pin or 0 8 notch. If inadequate spray device coverage is suspected, the following investigations should be performed: & The installation of the proper spray in its identified position should be confirmed. & The spray device may have multiple pieces that require clamps or slip pins to assemble, and each individual component should be permanently identified with an identifying part number. & If the sprays are not all welded, and are assembled pieces, confirm that the components are properly matched up and assembled. As discussed in chapter 9, many sprays are directionally drilled and must be indexed for proper installation in the nozzle in which they are located to assure proper coverage. Directionally drilled sprays will have an indexing pin or 0 8 notch, and the spray device schedule may provide supportive data to confirm the index position within the nozzle for proper spray coverage. Following confirmation of assembly, location, and indexing, it may be necessary to remove the spray to determine if there isdebris in the spray, causing an obstruction to flow through the complete spray pattern. If several of the holes are obstructed with debris, most commonly aloose gasket, then the spray coverage will be flawed and soil may not be removed from the entire vessel. An observation of the CIP supply pressure/flow relationship during an active cleaning cycle may provide an indication that the sprays may be plugged prior to having afailed CIP program. If aspray device is plugged with debris, the FCV may be operating within adifferent range to control flow, orthe CIP supply pressure may be higher than typical to overcome the resistance caused by spray blockage. A simple visual check through asight glass can sometimes reveal uneven spray coverage, suggesting apartially blocked spray. SUMMARY This chapter has presented what may seem to be overwhelming amounts of information to troubleshoot CIP systems, though the directives noted can be distilled into afew simple guidelines to troubleshoot any specific problem. Afew quick rules for troubleshooting successfully include 1. When afailure is noted by the CIP program, obtain the best data possible before entering the field. This includes the pertinent data historian trends for flow, pressure, conductivity, and temperature.
314 Rush 2. Troubleshooting is performed in the field allows the personnel to use their senses in the debug process. a. Vision to confirm equipment states b. Hearing for detecting proper pump operation, active flow, or spray coverage c. Touch for detection of temperature or flow 3. Once you have entered the field, start at the source of the problem and methodically work back through the system from the field device to the control system hardware. 4. While troubleshooting requires field observation, ateam approach involving an automation savvy helper at the HMI can support the field work to ensure prompt success. As in all detective works, athoughtful and methodical approach with proper background data and field observations can work to satisfactorily resolve any CIP system operational issue.
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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
Page 283 and 284: 262 Forder FIGURE 5 Pharmaceutical
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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
Page 293 and 294: 272 FIGURE 17 Sanitary Vbenders. So
Page 295 and 296: 274 one each for the upper, central
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Page 299 and 300: 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
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Page 336 and 337: 17 Waste Treatment for the CIP Syst
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Page 348 and 349: 18 Commissioning and Qualification
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Page 369 and 370: 348 & Sterilization refers to the r
Page 371 and 372: 350 Lankford All analytical methods
Page 373 and 374: 352 should be based upon scientific
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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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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