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CIP Distribution Piping Systems 187 6. The CIPR loop may also be 1.5 in. (40 mm) in diameter.This loop would receive the discharge from PP/RP,portable pump RP-2, or permanently installed pump RP-3 via lines which rise to ahigh point above the pumps, pitch to the loop, and then go through the loop to the primary return distribution valves and back to the unit. If necessary, the loop may drain in two directions both forward to the CIP system and backward tothe return pumps, which in that instance would need to be fitted with casing drain valves. Obviously, the various components of acomplete CIPS/R piping system described above may be used in many different combinations to achieve the required operating capability. The design objectives should include ( i )minimum line diameter to minimize line volume commensurate with ( ii)anacceptable supply side head loss with the spray device representing 30% to 50% of the CIPS pump discharge head and ( iii) areturn side head loss which will permit application of 1750 rpm return pumps. INTEGRATION OF CIPS AND CIPR PIPING AND PROCESS PIPING IN ACIP CIRCUIT Every effort should be made during the design process to minimize the amount of CIPS and CIPR piping required, by maximizing the use of process piping and equipment skid piping for CIP purposes. Figure 8, derived fromFigure 5previously discussed, will be used to illustrate this concept by describing the piping used to CIP clean BR-2, by following the flow of CIP flush, wash, and rinse solutions through the circuit. 1. The circuit will begin at the flow control valve on the CIP skid and continue through the primary CIPS to the CIPS loop at the top of the process, delineated as asolid line. 2. The mix-proof CIPS valve will be open to provide continuous flow, delineated by asolid line, to the BR-2 sprays via the BR-2CIPS valve manifold on the BR-2 bioreactor skid. 3. A CIPS valve on the loop will also supply TP-2 and the U-bend will be positioned to provide flow to the media line to BR-2. Intermittent flow to the vessel will be controlled by the process valves in the media leg piping and is delineated as adashed line. 4. Nine other bioreactor legs will be subject to intermittent flow controlled by sequencing of the BR-2CIPS valves and these are delineated by two short dashes in each line. These flows may vary from aone second “pulse” to a5-to 10-second interval, depending on leg length and diameter.The flow through the legs will be either ( i )tothe vessel, ( ii)the BRCIPR header which is valved to the main CIPR header,or(iii)the bioreactor condensate manifold, adirectdischarge to drain provided only at the end of each phase to clean the seats of valves which are not exposed to product. 5. The continuous flow from the sprays and the intermittent flow through legs to the vessel will drain continuously via the outlet valve and harvest line to TP-4, where the U-bend will connect to the CIPR header port. 6. The CIPR flush valve on the CIPS loop also will open intermittently to flush the full length of the CIPR header to RP-1. Adashed line depicts this flow.
CIPS loop Primary CIPS CIPSPS CIPS toTP-2 CS T TP-1 CIPS to TP-3 Mezzanine MP-4 MP-5 2000L 2000L MP-3 1000L MP-2 1000L MP-1 1000L MP-3 to TP-3 TP-2 TP-3 Floor (ref.) CIPS to BR2 TP-2 to CIPR header BR2CIPS valves Media line to BR2 188 CIP supply CIPR flush line CIP return BR3CIPS BR2 BR3 Compressed air Carbon dioxide BR1CIPS FIGURE 8 Heavy-line CIPS and CIPR illustration showing optimized integration of process piping with CIPS and CIPR. Abbreviations: CIPR, clean-in-place return; CIPS, clean-in-place supply; RP, returnpump. BR1 T Oxygen TP-4 TP-5 BR CIPR RP1 CIP skid T CIPR Bioreactor cond manifold Floor (ref.)
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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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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
Page 187 and 188: 166 Franks and Seiberling FIGURE 3
Page 191 and 192: 170 (A) (B) Franks and Seiberling F
Page 195 and 196: 174 The variables that impact the r
Page 197 and 198: 176 There are two guiding concepts
Page 199 and 200: 178 Mezz. Floor(ref.) V-5 1000L CIP
Page 201 and 202: 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: 186 Lebowitz suction-side port on T
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
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Page 232 and 233: 12 Cleanable In-Line Components INT
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Page 256 and 257: 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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