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CIP System Components and Configurations 115 FIGURE 16 This CIP skid is adrug mixing system that can clean four mixing tanks, and all associated piping to three downstream processes. phases of aCIP program tobemanually initiated. A230-V AC power supply compressed air and one or two waters are required for operation. Desirable Criteria for Pharmaceutical and Biotech CIP Systems The desirable criteria for apharmaceutical CIP unit were listed by Seiberling (3) in 1996 and are included here for easy reader access. 1. The unit should be constructed of components and materials which meet 3-A sanitary design requirements, or the evolving pharmaceutical industry equivalents as outlined by Clem in Chapter 12. 2. All solution contact surfaces should be polished to aRa20to25orbetter finish. This is aminimum polish applicable to the CIP skid tanks, pumps, valves, and interconnecting piping. Electropolish is specified by some users. 3. The CIP unit should operate reliably with aminimal quantity of solution in the total system, to reduce water, chemical, and steam requirements, time for filling and draining for each program phase, and the cost of treating aqueous waste.
116 Seiberling FIGURE 17 This mini-CIP skid is used for demonstrating fully automated CIP to an aseptic process course and acleaning validation course. Source:Courtesy of the ParenteralDrug Association (PDA)- Training and Research Institute (TRI). 4. The CIP unit design must provide for isolation of soft water and pure water supplies from chemical solutions. 5. The CIP unit recirculation tank and all interconnecting piping, pumps, and valves should be fully “self-cleaning” and drainable, and at the end of any completed programthe CIP skid solution contact surfaces should be as clean as the equipment to which it was connected. 6. The CIP skid and the associated controlsoftware should be of robust design and construction, to comply with Roebers suggestion (see Chapter 2) “If you cannot clean your process equipment and piping in arobust, validated way, donot even think about making apharmaceutical or biological product!” Location of CIP Skids Though CIP has been employed in the biopharmaceutical industry for morethan 15 years, not all processors, orsupport companies, are knowledgeable about the application to anew process or production facility. Space for CIP equipment is often not provided in the initial design, and when the concept is ultimately included, adequate space is not available in the proper location. The effective, and economical,
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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
Page 85 and 86: 64 B C D E FIGURE 17 Capability of
Page 87 and 88: 66 pH 13 pH 7 pH, %, Excess water h
Page 89 and 90: 68 dramatically increased rinsing t
Page 91 and 92: 70 desorption. If the affinity is v
Page 93 and 94: 72 & Cleaning procedure inthe case
Page 95 and 96: 74 effort being performed relativel
Page 97 and 98: 76 Rush & A1000 Lmixing vessel, hav
Page 99 and 100: 78 TABLE 2 Typical Single-Pass Chem
Page 101 and 102: 80 Rush Rinse Volume (Duration) The
Page 103 and 104: 82 Rush Intermediate Drain Objectiv
Page 105 and 106: 84 Rush Final Drain Phase (Gravity)
Page 107 and 108: 86 TABLE 4 Recirculated Chemical Wa
Page 109 and 110: 88 Rush type of soil include fermen
Page 111 and 112: 90 The pre-cleaning process flush w
Page 113 and 114: 92 REFERENCES Rush 1. Howard T, Wie
Page 115 and 116: 94 CIP return (CIPR)-piping to conv
Page 117 and 118: 96 Seiberling provided, generally o
Page 119 and 120: 98 Single-Tank CIP Skid Operational
Page 121 and 122: 100 Single-Tank Bypass or Recycle O
Page 123 and 124: 102 Seiberling Single-Tank Single P
Page 125 and 126: 104 Seiberling installation of an e
Page 127 and 128: 106 Chemical loop AB FE Chemical bl
Page 129 and 130: 108 Chemical loop AB FCV FE Steam C
Page 131 and 132: CIP supply Transfer line (typical)
Page 133 and 134: 112 Seiberling FIGURE 14 This singl
Page 135: 114 Seiberling FIGURE 15 This large
Page 140 and 141: 7 CIP System Instrumentation and Co
Page 142 and 143: CIP System Instrumentation and Cont
Page 164: CIP System Instrumentation and Cont
Page 167 and 168: 146 Lebowitz should be considered f
Page 169 and 170: 148 Lebowitz barrels and the chemic
Page 171 and 172: 150 Lebowitz Electromagnetic-Operat
Page 173 and 174: 152 Lebowitz FIGURE 5 The venturi o
Page 175 and 176: 154 Chemical pump enclosure Acid AL
Page 177 and 178: 156 Steam Facility acid header Faci
Page 179 and 180: 158 Lebowitz That is to say aweak a
Page 181 and 182: 160 CIP Philosophy The production p
Page 183 and 184: 162 Franks and Seiberling the numbe
Page 185 and 186: 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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