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Cleanable Liquids Processing Equipment and Systems 251 CIP3S UF CIPS CIP3R UF CIPR 2, 3 2, 3 2, 3 1 2,3 1 2 2 1,2 1,2 CIPR3 2 1,2 M UF feed CWFI 2 FE 2 1,2 2 1 CIPR4 1 2 labor is high. Figure 15 is aschematic of alarger and thus permanently mounted UF system designed to be cleaned using the UF feed vessel for supply to the UF feed pump in combination with added components on a“dual” CIP skid to supply ambient water for injection (AWFI), hot water for injection (HWFI), and heat for the CIP program. A“dual” CIP skid is shown in Figure 14 of chapter 6and described in the accompanying narrative. This process is an expansion of the concept of use of rising stem valves for mixproof isolation of two tanks in atrain illustrated in Figure 9. TK1 of the generic schematic is the UF feed tank and TK2 is the Downstream hold tank. Some basic design and operating features of this system include & The CIP skid supply pump delivers flush, wash, and rinse solution through a spray in the UF feed tank at aflow rate higher than required by the UF feed pump when operating at the CIP speed. The membrane system is thus subjected to fluids supplied by the feed pump only for Circuit 1, using all protective features incorporated in the UF system control hardware and software during CIP. & The UF feed tank is cleaned twice, first with the program required to clean the membrane system, via the “dual” CIP skid provision, and then again by the purification area CIP skid which cleans all other vessels and piping as Circuit 2. Following CIP of the membrane system it is filled with storage solution and then isolated by automatic valves. Some of the interconnecting 1,2 1 1 1 1 2 CWFI 1,2 2,3 2,3 1 UF filter 1 2 UF feed pump 1 3 FE 3 3 3 2, 3 Process waste 1 UF system using UF feed tank for CIP solutions 2 UF feed tank and piping from purification CIP skid 3 Down stream tank from purification CIP skid 2 1 Clean in two circuits M Down stream FIGURE 15 The incorporation of aUFfiltration system in the transfer line and the need for avastly different CIP program is described by the narrative with reference to the numbered arrowheads on this drawing.
252 Seiberling FIGURE 16 This tank top photograph shows the application ofarising stem mixproof valve in combination with diaphragm valves as shown schematically in Figures 9and 15. piping is, of necessity, cleaned in both circuits. Note the recycle line from the membrane to the UF feed vessel, the extension of the retentate line to the second rising stem mixproof valve to permit recycle also to the previous hold tank, and the final transfer line between vessels. & On completion of circuits 1and 2, and after the downstream tank is emptied, it is also cleaned from the purification area CIP skid as circuit 3. Figure 16 is aphotograph of atypical downstream tank included at this point to illustrate the arrangement of the inlet isolation mixproof valve and associated diaphragm valves. Filter Housing CIP in Transfer Line The use of filters as single or multiple units, and often on fixed or moveable carts is a part of most recent biopharmaceutical process designs. Some of these filters are very large, requiring hoists to remove the housing. New projects often include the desire to clean these housing in place, as part of the product piping circuit. Asection of Chapter 9discussed the means of accomplishing this. Figure 17 is aphotograph of apermanently mounted cart supporting two filters used for media filtration enroute to abioreactor selected by use of the U-Bend transfer panel upper right. Aconnection fromthe common port at bottom center to one of five ports in the circle above established the desired path. On completion of the transfer and clearing of the line, aspecial U-Bend fromthe upper right port to the common port introduces CIP flush, wash, and rinse solutions to the filter
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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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Materials of Construction and Surfa
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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
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
Page 318 and 319: 16 CIP System Troubleshooting Guide
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CIP System Troubleshooting Guide 30
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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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