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CIP System Instrumentation and Controls 123 Control of Mechanical Action Control of mechanical action of cleaning solutions is generally accomplished by control ofthe CIP supply flow rate. This procedure ensures proper flow velocities through all CIP supply, return, and product piping and to all vessel spray devices. The objective is to assure full lines and spray coverage. Flow control isgenerally accommodated by utilization of aflowmeter,flow control valve, and associated PID loop. This concept is indicated in Figure 1. The Vortex Shedding Flowmeter In the past, a sanitary vortex shedding flowmeter was the instrument most commonly used to measure flow in CIP applications. This instrument has been generally reliable and very cost effective for this application. The biggest downside to these instruments is the fact that they are only available with either 2 00 or 3 00 flowtubes. Frequently, pharmaceutical users have CIP applications with very low flow ranges (less than 75 L/min) which are below a2 00 vortex meter can read. This, of course, necessitates adifferenttype of instrument for the application. It should be noted that the CIP flow rate should never be less than that required for avelocity of 5ft/sec in the largest portion of the CIP supply/return piping in the circuit. Amagnetic flowmeter might be considered for this application; however, most pharmaceutical applications utilize high purity water whose conductivity is so low that this type of instrument will not work. The Mass Flowmeter Mass flowmeters have gained atremendous amount of popularity over the last few years and are often chosen for CIP applications also. These instruments, although much morecostly,are available in various sizes that can measurelow flow rates that the vortex shedding element cannot. Many earlier mass flow instruments were problematic with CIP applications; however, because of their very long recovery time when transitioning from anempty pipe to afilled system (also known as slug flow or two-phase flow). This resulted in unreliable flow readings during the initial burst rinses of a typical CIP tank cycle. Recent improvements in mass flow technology have eliminated this problem; however, and it is anticipated that these instruments will be the most popular for CIP applications in the future. It is recommended that the instrument manufacturer be consulted for the most appropriate flow tube design for aCIP application as the technology is being advanced all of the time. On afinal note, one must be careful to specify amass flow instrument that is both CIP cleanable and drainable. Many mass flow tubes require specific orientation to maintain drainability. The Flow Control Valve and Variable Speed Drive The vast majority of CIP applications use amodulating flow control valve to regulate the CIP supply. They are generally cost effective and provide the quickest response to system disturbances. In addition, the valve is sometimes used as a blocking valve during air blow steps to prevent air from blowing backwards through the CIP Unit. Variable speed drives on the CIP supply pump provide an alternative method of regulating flow and this has become much more economical as drive costs have dropped while the reliability of this technology has improved considerably. Some energy savings can be expected with this approach, but the quick response of the flow control valve is lost, and ablocking valve may still be required as part of the air
124 blow system. The flow control valve logic can incorporate ameans of clamping the valve at apoint near the normal operating position during the circuit and using a timer or counter to release the clamp when the fill is complete. This minimizes the time required to achieve stable flow. It is also possible to utilize aflow control valve and variable speed pump combined. This is particularly useful on systems where avery wide range of flow is expected or when the CIP system may supply circuits over awide range of vertical elevations. In such applications, it is sometimes difficult to specify a single modulating valve that will work for every circuit application. In general, the pump is run at aselected fixed speed during the selected CIP cycle while the flow control valve is actually used to regulate the CIP supply flow. AMORE COMPLEX CIP UNIT MODEL While the basic CIP unit model illustrates the most basic requirements for the proper control of cleaning solutions, it is not apractical model for real applications. Figure 3illustrates afully functional CIP system that requires additional instrumentation and controls to perform properly. These additional requirements are detailed in the following pages. Level Control Apractical CIP system will require the application of level monitoring instrumentation to provide ( i )control of the incoming water supply to the CIP skid water tank, ( ii) monitoring and control ofsolution tank level during recirculation sequences, PID Conductivity sensor/ analyzer PE/ PT PID CIP supply FE/ FT AE/ AIT TE/ TT To chem feed encl FCV COND CIP supply pump FPA Steam Shell &tube heater TCV Recirc tank FIGURE 3 Pharmaceutical CIP model. LE/ LT Chem feed loop PID CIP motive pump CIP return Drain Return probe FSL AE/ AIT Resistivity sensor/ analyzer TE/ TT LCV LT Vent filter WFI supply tank 80 gal WFI supply Andersen PSE
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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
Page 93 and 94: 72 & Cleaning procedure inthe case
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Page 97 and 98: 76 Rush & A1000 Lmixing vessel, hav
Page 99 and 100: 78 TABLE 2 Typical Single-Pass Chem
Page 101 and 102: 80 Rush Rinse Volume (Duration) The
Page 103 and 104: 82 Rush Intermediate Drain Objectiv
Page 105 and 106: 84 Rush Final Drain Phase (Gravity)
Page 107 and 108: 86 TABLE 4 Recirculated Chemical Wa
Page 109 and 110: 88 Rush type of soil include fermen
Page 111 and 112: 90 The pre-cleaning process flush w
Page 113 and 114: 92 REFERENCES Rush 1. Howard T, Wie
Page 115 and 116: 94 CIP return (CIPR)-piping to conv
Page 117 and 118: 96 Seiberling provided, generally o
Page 119 and 120: 98 Single-Tank CIP Skid Operational
Page 121 and 122: 100 Single-Tank Bypass or Recycle O
Page 123 and 124: 102 Seiberling Single-Tank Single P
Page 125 and 126: 104 Seiberling installation of an e
Page 127 and 128: 106 Chemical loop AB FE Chemical bl
Page 129 and 130: 108 Chemical loop AB FCV FE Steam C
Page 131 and 132: CIP supply Transfer line (typical)
Page 133 and 134: 112 Seiberling FIGURE 14 This singl
Page 135 and 136: 114 Seiberling FIGURE 15 This large
Page 137 and 138: 116 Seiberling FIGURE 17 This mini-
Page 140 and 141: 7 CIP System Instrumentation and Co
Page 142 and 143: CIP System Instrumentation and Cont
Page 164: CIP System Instrumentation and Cont
Page 167 and 168: 146 Lebowitz should be considered f
Page 169 and 170: 148 Lebowitz barrels and the chemic
Page 171 and 172: 150 Lebowitz Electromagnetic-Operat
Page 173 and 174: 152 Lebowitz FIGURE 5 The venturi o
Page 175 and 176: 154 Chemical pump enclosure Acid AL
Page 177 and 178: 156 Steam Facility acid header Faci
Page 179 and 180: 158 Lebowitz That is to say aweak a
Page 181 and 182: 160 CIP Philosophy The production p
Page 183 and 184: 162 Franks and Seiberling the numbe
Page 185 and 186: 164 Franks and Seiberling Similar s
Page 187 and 188: 166 Franks and Seiberling FIGURE 3
Page 191 and 192: 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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