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Introduction and Historical Development 13 CA (pulse) AWFI CIP skid Drain T,L CA Vent T1V3 Vent T filter T1V1 (Pulse) T,L T1 CIP supply CIP return T1V2 AWFI T TP1 (Pulse) T,L L CIPS3 CIPS1 T L Transfer line CIPS2 (Intermittent) L AWFI T,L T CS T,L T,L F1V1 CIP return pump CA Vent CIP return remove the cartridge after which the housing would be replaced after manually cleaning the base joint and gasket area. The TP U-Bends would be installed as described for the more simple circuit shown in Figure 7. Filter valves F1V1 and F1V4 would be open full time for CIP. Tank T1 would be sprayed and the fill line “pulsed” as described above for tank CIP. However, when CIPS2 would open for perhaps 20 to 30 seconds of each minute, allowing flush, wash and rinse solutions to pass through the transfer line and filter housing in areverse direction, F1V2 would be pulsed for two to three of the 20 to 30 seconds, allowing solution passage through the filter inlet line and valve. Then, when F1V2 closes, the reverse flow will spray the filter housing via the permanently installed ball or disc-type distributor (see chap. 9), the flow being caused by the back pressure created by the T1 sprays. The filter housing may be evacuated by the CIPR pump only, ormay be assisted by the introduction of acontrolled flow of CA to the CIPS line at the CIP Skid. The intentional injection of air to the CIPS flow will require areturn system and CIP Skid that can handle retained air, and these will be discussed in chapter 6. SIP of the Transfer Line with Filter Housing and Destination Vessel Figure 9illustrates one method of steaming the assembled components of the combination vessel and line CIP circuit (Fig. 8) for sterilizing purposes. Following CIP, the filter cartridges would be installed in the product filter and vent filter and the appropriate U-Bends would be installed on T1TP1 and T2TP2, with steam traps as shown. CS supplied to T2 via use of the 3-Leg U-Bend would then be cycled in sequence through the transfer line and process filter with the vent open to remove air, after which the vent valve would be closed and steam admitted at the top and bottom would continue to the trap on T1TP1. Then, with the T2 vent valve open, T2V2 would be opened to admit steam to the bottom of T2, driving air out the top. Vent CA F1V4 F1V3 Vent filter F1V2 (Pulse) T,L FIGURE 8 This version of the schematic includes aproduct filter housing in the transfer line. CIP of T1, transfer line and filter housing is described in the narrative. Air L L T2 T2V3 T2V2 T2V4 T2V1 TP2 L CS Next tank CIP flush line
14 AWFI CIP skid Drain When steam appears at the vent valve, it would be closed and steam would be admitted to all of the remaining tank top piping to bring the entire system to temperatures and pressures required. THAT IS CIP! CA Vent Vent filter T1 CIP supply CIP return T1V2 T1V3 AWFI T1V1 TP1 T CIPS1 CIPS2 Transfer line CS F1V1 CIP return pump CIP return The selection, arrangement, and installation of the above-described generic CIPcleaned process may vary in many ways, for example: & Vessels may vary in capacity from 30Lto 16 m 3 ,orlarger. & Vessels may be fixed or portable, or acombination of both. & Vessels may be simple in design and function (e.g., media prep or buffer prep), or complex (e.g., abioreactor with multiple legs to be cleaned with the vessel). & CIPS/R and product piping may be fixed, or fixed in combination with flexible hose final connections to portable equipment. & Individual TPs may be replaced with larger top and bottom located multitank TPs. & For the production facility, all TPs may be replaced with valve arrays of diaphragm, rising stem mixproof, or diaphragm mixproof type, to enhance control and minimize labor requirements for conversion fromproduction to CIP and back. & Transfer lines may be smaller (generally) than CIPS/R piping, and may include other equipment in the transfer path. Some components which permit flow in only one direction, i.e., adiaphragm pump, may require abypass for CIP in reverse flow. Vent CA F1V4 F1V3 F1V2 Vent filter CA Vent T2 T2V3 T2V2 AWFI T2V4 T2V1 TP2 T Seiberling FIGURE 9 This version of the schematic illustrates the flow path for SIP sanitizing of T2 with the filter housing and transfer line prior to the T1 T2 transfer. The design would also permit hot water sanitizing. Afull sterile process would require several added valves to maintain sterility during removal ofthe 3-Leg U-Bend after sterilize-in-place. CIPS3 CS Next tank CIP flush line
Page 2: Clean-In-Place for Biopharmaceutica
Page 13 and 14: Informa Healthcare USA, Inc. 52 Van
Page 15 and 16: iv Preface period, the industry rec
Page 18 and 19: Preface iii Contents Acknowledgment
Page 20: Contributors Barry J. Andersen Seib
Page 23 and 24: 2 the last step of abatch manufactu
Page 25 and 26: 4 Seiberling The vessel capacity ma
Page 27 and 28: 6 Seiberling any two ports. For pur
Page 29 and 30: 8 AWFI (or Any Water) Supply If the
Page 31 and 32: 10 Seiberling program, and through
Page 33: 12 Seiberling (380 L) for the solut
Page 37 and 38: 16 Seiberling products in asingle f
Page 39 and 40: 18 Seiberling The literature began
Page 42 and 43: 2 Project Planning for the CIPable
Page 44 and 45: Project Planning for CIPable Facili
Page 62 and 63: 3 Water for the CIP System Jay C. A
Page 64 and 65: Water for the CIP System 43 FIGURE
Page 66 and 67: Water for the CIP System 45 of clea
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
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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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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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