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Cleanable API Processing Equipment and Systems 291 The first three devices aregenerally chosen for afacility designed for CIP.The reasons are: & The inlet/outlet connections are fixed & The internal design can be adapted for ease of cleaning Rotary double cone dryers can be cleaned in place, but the need to make and break large diameter connections makes them a less-than-ideal selection. Tray dryers are made less suitable for CIP due to the internal trays and structure. Figure 7depicts aconical dryer designed for CIP. The CIP piping is shown in alternating short/long dashes. A conical or pan dryer does not normally handle process liquids. In the example shown, aportable CIP skid is positioned below the dryer discharge chute. This skid includes a tank of 100 to 200 gal capacity, a circulating pump, and instrumentation. There are six major CIP circuits defined by the numbered arrow heads including (1) the dryer vessel circuit, (2) the dust filter housing, (3) the charge chute and emergency vent system, (4) the vent line, and (5) the discharge chute. Spent solutions are pumped to waste per path (6). The vendors of dryer systems have recently begun to offer CIP spray devices and guarantee CIP performance. PIPING DESIGN CONSIDERATIONS To alarge extent, the piping design of an API facility will determine the ultimate success of cleaning. The most important aspects include: & L / D ratios of fittings & Orientation of fittings & Drainability The L / D ratio can be defined as: & L is the leg extension from the internal wall of the major flow axis. & D is the internal diameter of the leg or extension. Obviously,bymaking the L / D ratio as small as possible, the cleaning of dead legs is made easier. Inrecent years, the manufacturers of Teflon-lined pipe have started to make short stacked tees with greatly reduced L / D ratios. These should be used in place of standard tees. Reducing tees should be avoided. The orientation of piping branches and dead legs also should be carefully considered. Horizontal lines with atee positioned in avertical-up position will trap gas, while atee positioned in the vertical-down orientation will trap solids. Tees positioned in ahorizontal orientation will avoid both of these problems. The piping designer should slope piping back to avessel or local low point, which can be drained automatically at the end of each cycle. CIP FLUID/WASTE DISTRIBUTION The goal in the CIP of API systems is to use as much of the process system as possible to supply,condition, and distribute CIP fluids and direct cleaning waste to the appropriate final destination.
292 A Vent to atm. B M Conical dryer Solid charge 5 Dust filter 1 PC 2 Portable CIP skid 3 4 FC FE Bubble spray (typical) Ball spray (typical) CIPs line (typical) CIP fluids CIP header 6 Vacuum system C Cerulli Waste FIGURE 7 Typical conical dryer circuit. Abbreviations: FE, flow element; PC, pressure controller.
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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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Cleanable Liquids Processing Equipm
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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: 290 CIP fluids Process fluids 1 2 3
Page 315 and 316: 294 One of the designer’s first t
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Page 336 and 337: 17 Waste Treatment for the CIP Syst
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Page 348 and 349: 18 Commissioning and Qualification
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Commissioning and Qualification 341
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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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