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Cleanable In-Line Components 233 communication is via a hardwire connection. Although wireless technologies are frequently used in industrial processes, and pneumatic signals are still utilized in some classified environments, the hardwire connection is most prevalent in hygienic process control. Whether this is analog, Ethernet, or afieldbus signal, it is important to consider the wiring methods and their impact on housekeeping in a good manufacturing practice environment. Use of nonmetallic conduit and fittings is encouraged to minimize opportunities for corrosion and particulate generation (Fig. 16). Use of all welded, sanitary tubing as low-voltage conduit is frequently an accepted method to maintain hygienic conditions in and around instrumentation. This system may require use of plenum-rated cables, but is ultimately azero maintenance installation. REFERENCES FIGURE 16 Pressure sensor with nonmetallic conduit. 1. 3-A Sanitary Standards, Inc., 6888 Elm Street, Suite 20, McLean, Virginia 22101, U.S.A. Tel.: 703 790 0295; Fax: 703 761 6284; www.3-a.org 2. American Welding Society,550 N.W.LeJeune Road, Miami, Florida 33126, U.S.A. Tel.: 800 443 9353; www.aws.org 3. ASME International, Three Park Avenue, New York, New York 10016-5990, U.S.A. Tel.: 800 843 2763; Fax: 212 591 8676; www.asme.org
234 Clem 4. ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, Pennsylvania 19428-2959, U.S.A. Tel.: 610 832 9500; Fax: 610 832 9555; www.astm.org 5. EHEDG Secretariat, Avenue Grandchamp 148, B-1150 Brussels, Belgium. Tel.: 32 02 761 7408; Fax: 32 02 763 0013; www.ehedg.org 6. ICH Secretariat, c/o IFPMA, 15 ch. Louis-Dunant, P.O. Box 195, 1211 Geneva 20, Switzerland. Tel.: 41 22 338 32 06; Fax: 41 22 338 32 30; www.ich.org 7. Tuthill AH, Brunkow R. Stainless steels for bioprocessing. BioProcess Int 2004; 3(11):46–53.
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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
Page 203 and 204: 182 Lebowitz U-bend transfer panels
Page 205 and 206: 184 Lebowitz oriented vertically. T
Page 207 and 208: 186 Lebowitz suction-side port on T
Page 209 and 210: CIPS loop Primary CIPS CIPSPS CIPS
Page 211 and 212: 190 Lebowitz FIGURE 10 Photo of sma
Page 213 and 214: 192 Drain CIP return Drain Recycle
Page 216 and 217: 11 Materials of Construction and Su
Page 218 and 219: Materials of Construction and Surfa
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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
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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
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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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