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CIP System Components and Configurations 95 TABLE 1 ComparisonofWater Requirements to Fill Clean-In-Place Supply and Return Piping and Process Piping Associated with Vessels of Various Sizes and Types in aLarge Biopharmaceutical Facility Vessel type Volume (L) CIPS (ft) CIPS dia (in.) CIPS (gal) CIPR (ft) CIPR dia (in.) CIPR (gal) Total line (gal) Media prep 200 140 1.5 11 180 1.5 14 25 Media prep 4,000 200 1.5 and 2.0 31 210 2.0 30 61 Media prep 12,000 200 1.5 and 2.0 31 210 2.0 30 61 Bioreactor 120 280 1.0 and 1.5 21 200 1.5 15 36 Bioreactor 600 350 1.0 and 1.5 26 85 2.0 26 52 Bioreactor 3,000 450 1.0 and 1.5 35 180 2.0 26 61 Bioreactor 15,000 700 1.0, 1.5, and 2.0 83 140 2.5 16 99 Buffer prep 4,000 220 2.0 and 2.5 50 205 2.0 29 79 Buffer prep 13,000 220 2.0 and 2.5 50 205 2.0 29 79 Purification 4,000 190 1.5 16 90 2.0 13 29 Purification 10,000 210 1.5 18 160 2.0 26 44 Formulation 3,000 80 1.0 and 1.5 6 60 2.0 9 15 Abbreviations: CIPR, CIP return; CIPS, CIP supply.
96 Seiberling provided, generally on the skid. Some designers provide a separate supply reservoir for each flush, wash, and rinse solution required by the CIP program. Presented in Figure 1isacomposite design of all the components required to configure aone-tank or two-tank skid to operate in three different manners. The circled numbers 1–20 arereferenced in parentheses in the following paragraphs that explain each component’s function. Major Components ACIP recirc tank, sometimes used also as the only water tank, is apart of all CIP skids (1).The combination of aconical (or dish) bottom tank and outlet leg provides adequate net positive suction head (NPSH) for the CIP pump with aminimal volume of water in the tank. Atank outlet valve (TOV) (2) controls supply to the CIP pump (3). Acasing drain on this pump is at the lowest point on the skid and will fully drain the complete skid at the end of the program. Ashell and tube heat exchanger (4) is shown vertically mounted for space considerations and drainability is provided by installation of atangentially drilled restrictor between the inlet and outlet tees. Heat exchangers may also be mounted horizontally,apreferred practice for large units. Steam supply and temperature controlisdiscussed in Chapter 7. The CIPS piping on the skid includes the conductivity sensor,pump discharge pressure sensor,and CIPS temperature sensor,all near (5), and the flow continues to the flow element (generally avortex meter, mass flow meter, orturbine meter) and aflow control valve (6). The choice of athrottling-type valve or apump with avariable frequency drive for flow rate control inturn based on the meter analog output is described in Chapter 7. The two close coupled valves (7) are optional and will be discussed as part of three differentconfiguration scenarios. The CIPS then continues to the process and the circuits. ACIPR manifold on the skid is the general location for areturn-flow probe (discrete), return-temperature probe, and resistivity probe, all (8). Areturn flow hold-back valve (HBV) (9) is optional. The means of establishing recirculation through the tank or around the tank will be discussed as part of the configuration scenarios. Single- or Multi-Tank Variation Asingle-tank skid would require the provision of the water supply to the CIP recirc tank. Asingle ambient water for injection (AWFI) source is shown via valve (14) to aspray device (12). Two waters of different quality, ortemperature, are commonly used, and both are supplied through individual spray devices. A multi-tank CIP skid may be fitted with one or more water tanks to accommodate the different water qualities or temperatures. The hot water for injection (HWFI) TANK (16) is shown as an American Society of Mechanical Engineers (ASME) vessel equipped with a rupture disc and is supplied with HWFI by valve (18) through aspray to flush the tank head and sidewalls, under control of alevel probe. Avent filter is shown and atemperaturesensor and sample valve are indicated (19). If this tank is intended to be SIP’d it would be insulated. Chemical supply to the skid is shown by means of achemical loop that originates at optional valve (20), with arestrictor adjacent downstream to control flow through the loop (see Chapter 8). The return connection for this chemical loop is optional and will vary with the operating scenario.
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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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Page 70 and 71: Water for the CIP System 49 FIGURE
Page 72: Water for the CIP System 51 WATER U
Page 75 and 76: 54 Time Temperature FIGURE 2 The cl
Page 77 and 78: 56 Classification of Cleaners by pH
Page 79 and 80: 58 [mg/sec] Cleaning velocity C v ,
Page 81 and 82: 60 + - Na O O C CH 2 CH 2 (CH 2 ) n
Page 83 and 84: 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: 94 CIP return (CIPR)-piping to conv
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
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Page 137 and 138: 116 Seiberling FIGURE 17 This mini-
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
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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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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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