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Cleanable In-Line Components 229 equipment. While it is possible to use gas overpressure to transfer fluids from a vessel, the ability to use speed controls to alter flow rates, pressures, and levels make the use of pumps very common in process systems. Installation of pumps needs to consider accessibility for maintenance such as seal replacements, lubrication, and general housekeeping. It is also important to consider physical location as the prime movers for pumps include electric motors or hydraulic motors, both of which require attention to cooling as well as the fact that they often contain many crevices and openings that are not desirable from a clean process environment perspective. Electric motors with fan cooling are often considered to be sources of particulates not desired in clean process spaces. These issues are sometimes addressed by placing pumps in service or “gray” space and allowing the piping to penetrate walls to/from the process. It is also important to consider the needs for system drainage, line pitch, and vibration potential. In many process systems, pumps are equipped with low-point casing drains to enable complete evacuation of fluids from the system. The hygienic aspects of pumps need to include appropriate materials of construction for the main pump chambers and, perhaps more important, all sealing points. With the exceptions of air-operated double diaphragm (AODD) and peristaltic type pumps, all other pump types include some sealing method on arotating shaft. The complex nature ofrotating seals is inherently difficult to flush and clean. Often the best design option is to place the seal mechanism outside of the product contact zone, relying on aminimal elastomer exposure to product and cleaning solutions. Another design method utilizes double mechanical seals, with two rotating seal surfaces, and the option to use a flushing liquid in the area between these sealing faces. In all cases, the rotating seal faces rely on either a flush liquid or the process liquid to lubricate the rotating mating surfaces. Although this lubrication uses extremely small quantities, it nevertheless presents aneed for cleaning solutions to also be utilized to clean these surfaces. Centrifugal Pumps Centrifugal pumps designed for hygienic applications often include impeller retention methods that completely isolate the driving shaft from the liquid being pumped (Fig. 13). Static seals are used to prevent fluids from touching threaded fasteners such as impeller retaining bolts or the impeller includes an integral shaft that can extend beyond the fluid chamber (Fig. 14). The result is that process residues can be easily rinsed and cleaning solutions effectively cover all product contact surfaces. Similar construction and impeller retention methods are used for rotary lobe pumps. In fact, whereitwas once necessary to remove the lobes or rotors from rotary lobe pumps to assure access of cleaning solutions, there is now available, positive rotary lobe pumps that do not require disassembly prior to using CIP procedures. Progressive Cavity Pumps Progressive cavity pumps are also available for CIP applications. It should be noted that extreme care must be taken to prevent dry running of the rotor inside of the stator as this can cause rapid destruction of the mating surfaces of the stator.
230 FIGURE 13 Hygienic impeller retaining nut. FIGURE 14 Hygienic retaining nut and seal. Clem
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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
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 and 208: 186 Lebowitz suction-side port on T
Page 209 and 210: CIPS loop Primary CIPS CIPSPS CIPS
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 256 and 257: 13 Cleanable Liquids Processing Equ
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Page 268 and 269: 1-9 CIPS 2 Plant steam CIPS valves
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Page 279 and 280: 258 8. Projectile-type thermometer
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Page 283 and 284: 262 Forder FIGURE 5 Pharmaceutical
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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
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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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