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Cleanable Solids Processing Equipment and Systems 269 Additional areas of concern are the isolation valve in the bottom of the fluid bed dryer body and the diffusion screens. These pieces of equipment may be cleaned in place but will need to be inspected during start-up to ensure they are adequately cleaned. Cleaning of the atomizer for the fluid bed dryer can be approached in asimilar manner to the atomizer cleaning used in spray dryer operations. The actual integration of the automated cleaning cycle and equipment can be approached in much the same manner as other tanks and vessels. Figure 14 illustrates an approach to incorporating the many different components of adry powder process into aCIPable process, and though published in 1995 (1), itisstill representative of an approach in current use. Typical Spray Dryer CIP Cycle Separate cleaning circuits may be developed and used to ensure adequate flow to sections of the dryer and ancillary equipment like the baghouse. Aset of circuits may clean the dryer body, the cyclone, and then a final collection device or baghouse. The CIP sequence should incorporate the same steps as cleaning a fermentor or tank, including rinse, caustic wash, acid wash, final rinse, and dry. The prerinse will be used to wash off powder contacting services and depending upon application may be sent to waste or pretreatment prior to waste. An alkaline wash is used for primary cleaning of the dryer. The wash solution should be at temperatures 658 Cto70 8 Cand solution makeup should incorporate aformulated cleaner or sodium hydroxide or potassium hydroxide. Awater rinse and airblow can be used after the alkaline wash. CIP collector Lift door Tote &cover cop housing Return pump CIP collector CIPR Return pump COP tank Return header w/ collector funnels Discharge to equalization tank CIPR valves CIP skid CIPS valves Explosion relief Trans CIPR line CIPR CAP CIPS Collector CAP Roof line CIPR Tote dumper CIP collector FIGURE 14 Schematic diagram of aCIPable dry products process. Abbreviations: CIPR, cleanin-place return; COP, cleaned-out-of-place; RTD, resistance temperature detector. CIPR
270 The acid wash of 85% phosphoric acid or equivalent is then used for neutralization and mineral removal. The acid wash is followed by arinse and airblow followed by afinal water-for-injection rinse. Where this would normally be the end of the washing cycle for tanks and vessels, the configuration of the spray dryer allows for quick and efficient drying of the dryer after CIP. Afinal drying step should be incorporated into the dryer CIP sequence. This can usually be nothing more than passing heated process gas through the dryer body and collection equipment. GLOVE BOXES AND BARRIER EQUIPMENT Barrier equipment or glove boxes are used in dry powder operations for containment and product/operator protection. The glove box provides aphysical barrier between the processing operations and the outside environment. Some examples of application include protecting operations personnel during cytotoxic product processing or keeping hydrophilic powders dry during processing (Fig. 15). Design Considerations for Glove Boxes Incorporating CIP The glove box uses ahigh-efficiency particulate air (HEPA) or similar filter to filter air into or out of the glove box. Glove boxes may be purged with clean dry air or FIGURE 15 Sanitary glove box. Source: Courtesy of La Calhene, Inc. Forder
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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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Page 279 and 280: 258 8. Projectile-type thermometer
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Page 287 and 288: 266 FIGURE 9 Pleated filter cartrid
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Page 293 and 294: 272 FIGURE 17 Sanitary Vbenders. So
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Page 297 and 298: 276 CIP VS. TRADITIONAL BOIL-UP MET
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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
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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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