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Index 383 [Cleaning cycle sequences] development of, 73–74 master recipes, 84–90 acid and alkaline cleaners, 87–88 aqueous based cleaning program, 84–87 clean hold expiration times, 91 solvent assisted, 90 based, 88–90 process controls, 90–91 CIP hold dirty expiration timer, 91 rinse phase, 79–80 Cleaning process, 53–54 validation of, 69–70 Cleaning programs, 10–12 alkaline solution wash, 11 post-acid rinse, 11 post-wash rinse, 11 pre-wash rinse, 10 variables of, 29 water requirements, 10–12 Cleaning regimes, 31 Cleaning requirements, water requirements, 11–12 Cleaning temperature, impact of, 78 Cleaning validation, 328–329 acceptable criteria, 351–354 consecutive iterations, 353–354 contaminant/cleaning agent residue limits, 351–353 visual, 351 analytical techniques, 354–356 nonspecific methods, 355–356 selective method, 354–355 specific method, 354–355 levels of, 358–359 sampling techniques, 356–358 single vs. multi-product equipment, 358–359 strategies, 347–359 sanitization vs., 347–348 sterilization vs., 347–348 study design and implementation, 348–351 FDA expectations, 348 master plan, 349 policy, 349 studies, 349–350 Commissioning, 36–37 Composition of cleaning agents, 53–72 Condensers, 284 Conductivity alarms, 304–305 set point, 304–305 Conductivity sensing element, 127 Construction issues, 36 Construction materials, 195–208 corrosion, 197–199 residue removal, affect on, 207 stainless steel, 195–197 Containment systems, chemical storage and handling, 146 Contaminant/cleaning agent residue limits, 351–353 Control ofmechanical action, 123–124 flow control valve, 123–124 mass flowmeter, 123 variable speed drive, 123–124 vortex shedding flowmeter, 123 Controls, CIP systems and, 119–143 COP. See Cleaned out-of-place Corrosion, 197–199 crevice, 197 fatigue, 198 galvanic, 197 inhibitors, 69 intergranular, 197 microbial influence, 198 pitting, 197 rouge, 198 stress cracking, 197 Coverage criteria, spray cleaning and, 162 Coverage testing, 334–335 Coverage verification, spray, 173–174 Crevice corrosion, 197 Datalogging, CIP System instrumentation and control quality tools, 140–143 DCS. See Distributed control system Dead ends, elimination of, 219–220 Dead legs in flow distribution, 182–187 Dedicated production process, mixproof valves and, 240–241 Defoamer, 66–68 Descalers, 56 Design for cleaning ferrite number, 208 metal thickness, 208
384 [Design for cleaning] surface, 207–208 welds, 208 Destination vessel, 13–14 Detergents, composition of, 55–58 acidic, 56 neutral cleaners, 56–57 Device sequences, 331–333 matrix, 133–135 Diaphragm pumps, 149–153 air operated, 149 electromagnetic, 150 meter based, 153 motor operated, 150 peristaltic type, 150 venturi, 150–153 Diaphragm valves, 225–228 multi-port, 226–227 single-port, 225–226 zero dead-leg, 227–228 Diaphragm-type mixproof valves, 243 Distributed control system (DCS), 130–131 programmable logic controller (PLC) vs., 31 hybrid of, 131–132 Distributing piping systems, 175–193 Distribution dead legs, 182–187 loops, 184–186 valves, 183–184 Distribution valves, 183–184 positions, 183–184 Double containment system, 146 Double diaphragm pumps, 231 Double seat rising stem valves, 224–225 Drain, intermediate, 82 Drain phase, 74 final, 84 Dryer equipment CIP, 290–291 Duration gas blow and, 81 rinse phase and, 80 Eductor return flow, 178–179 Eductor-assisted pumped return flow, 179–180 Effluent, 315–316 Electromagnetic diaphragm pump, 150 Electron spectroscopy for chemical analysis (ESCA), 206 Index Electropolish, 202, 213 Engineering considerations, CIP facility project planning and, 33–34 Environmental effects, cleaning agent constituents and, 70–71 Equipment layout, 33 Equipment procurement, 34–36 ESCA. See electron spectroscopy for chemical analysis European Union regulations, 363–364 Germany, 363–364 Expansion of piping connections, 217 Eye wash equipment, 146–147 Fabrication expansion considerations, 217 non-permanent joints, 214–215 permanent joints, 214 piping system slope, 217 pressure limitations, 216 support system, 217 Failure to start, 298–300 batch recipe, 299 interlock, 300 permissive, 299–300 Fatigue, stainless steel, 198 FDA cleaning validation expectations, 348 regulations, 362–363 test until clean observations, 277 Ferritic steel, 195 Filter housing, 13–14 CIP, 252–253 sprays, 170–173 Final drain phase, 84 Final rinse conductivity check, 128 inadequate, troubleshooting of, 311–312 phase, 75 high quality water, 83 Fixed piping systems, 175–176 Fixed spray devices, 160–161, 163–168 ball-type, 163–164 coverage, 167 flow rate, 168 positioning, 164–166 Flanged joints, 214–215 Flexible hoses, 217–218 Flexible tubing, 236
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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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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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Commissioning and Qualification 331
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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 395 and 396: 374 TABLE 1 Directives of the Europ
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Page 400 and 401: Index Accessibility, 28 Acid cleane
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Page 410 and 411: Index 389 Rising stem valves, 223-2
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