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Waste Treatment for the CIP System 323 chemicals together in alarge equalization tank prior to the addition of neutralization chemicals in subsequent mix tanks. In practice, this result may be difficult to achieve in a large facility with multiple process and CIP systems operating simultaneously. Often the wastewater flow rate carries the alkaline wash through the system before the acid wash can blend in to equalize it 20 to 30 minutes later. High Temperature Wastewater from CIP circuits is often hot (65–858 C) and can cause the facility’s waste stream to exceed allowable discharge limits for temperature. The heat of the CIP effluent is combined with blowdown streams fromthe large distillation systems and other steam condensate sources to significantly raise the temperature of the waste stream leaving the facility. Provisions should be made for cooling this wastewater to below permit requirements. The waste stream can be cooled down to 358 Cto40 8 Cwith aplate and frame type heat exchanger and plant cooling water of appropriate temperature. The opportunity exists for energy savings if the CIP circuits are designed and validated to operate at lower temperatures. Total Phosphates Many cleaning chemicals contain phosphates or phosphoric acid both of which contribute to the total phosphorus in the wastewater stream. Aswas noted previously, this nutrient is often tightly regulated to prevent excessive algae and plant growth in the nation’s lakes and rivers. Not all POTW facilities are designed for nutrient removal (e.g., phosphurus, nitrogen) which can result in arequirement for the biopharmaceutical facility to meet the final nutrient discharge requirements for the receiving body of water. The on-site treatment of phosphorus is not preferred as it typically involves either achemical precipitation reaction ora complex biological process. The best approach is to avoid CIP chemicals that contain phosphates or phosphoric acid if at all possible. One alternative to phosphoric acid for CIP cleaning is hydroxyacetic acid (also called glycolic acid). The use of these alternate cleaners needs to be considered early in the process development and cleaning validation. Biochemical Oxygen Demand (BOD) Finally, CIP wastewater may contain high levels of biochemical oxygen demand (BOD) depending on the area of the biopharmaceutical facility being cleaned. In particular, circuits that clean cell debris from fermentation and harvest areas result in high BOD loads in the CIP effluent, especially the initial rinse steps. BOD is a measurement of the organic loading in awaste water stream. BOD is typically measured with a5-day analytical test that determines the amount of dissolved oxygen used by microorganisms in the biochemical oxidation of organic matter. Because most POTW facilities use microbialprocesses to treat their incoming waste stream, this measure is used to size and operate their treatment plants. High or variable levels of incoming BOD will directly impact their ability to operate. Similar to phosphorus, on-site treatment of BOD is not preferred due to the complexity of operating these systems. However, BOD equalization may be necessary depending on the facility permit requirements. In this case, high BOD waste streams are segregated within the plant and collected in alarge vessel.
Biowaste BOD Plant steam 324 Retention tube Hex-1 Hex-2 N.C. Hex-3 T-1 T-3 BOD receiver P Cooling water Kill system recirc tank Hex-4 P-1 T-2 Rauch and Ankers P-2 P-3 P-4 Biowaste receiver FIGURE 7 Typical continuous biowaste inactivation system. Abbreviations :BOD, biochemical oxygen demand, NC, normaly closed.
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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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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
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
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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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Page 348 and 349: 18 Commissioning and Qualification
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Page 371 and 372: 350 Lankford All analytical methods
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Page 375 and 376: 354 Lankford acleaning validation p
Page 377 and 378: 356 In summary, TOC analysis is are
Page 379 and 380: 358 In-Situ In-situ measurement tec
Page 381 and 382: 360 15. Karen A. Clark, Product Man
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Page 385 and 386: 364 §211.100 Written procedures; d
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Page 389 and 390: 368 Equipment Regulation C.02.005 T
Page 391 and 392: 370 … C.02.004 … 4. Pipework sy
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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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