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7 CIP System Instrumentation and Controls INTRODUCTION Barry J. Andersen Seiberling Associates, Inc., Beloit, Wisconsin, U.S.A. Successful clean-in-place (CIP) operations require acontrolled combination of time, temperature, chemical concentration, and mechanical action to provide satisfactory performance on a repeatable basis. This chapter discusses and reviews the instrumentation and control concepts required to ensurethat above criteria aremet. This chapter will consider the following items: & Common instrumentation utilized to control the CIP process and verify system performance & Review performance requirements as they relate to the selection of programmable logic controller (PLC) systems and distributed control systems (DCSs) & Software development concepts as they relate to CIP & CIP System Quality Control Tools ABASIC CIP UNIT MODEL A basic recirculating CIP unit model is shown in Figure 1. The minimum instrumentation and control elements required to control time, temperature, concentration, and mechanical action are highlighted in this diagram. The intent of this model is not to illustrate the actual mechanical details of aCIP system (as in Chapter 6) but to identify the most basic instrumentation and control needs for any application. A brief discussion of the various components utilized to achieve this control follows. Time Control In the very early days of CIP, the control systems used for these applications generally consisted of relays, cam timers, and stepping switches. The cam timer served as areliable and accurate means of controlling the lengths of various steps of the CIP program, including the duration of the chemical wash steps. Today’s PLC systems and DCSs provide the required timing functions in software that replaces all of the old hardwired devices. Time control today is merely a function of adjustable variables within the operating programs for the system. Although it is easy to take time control for granted with today’s modern control systems, there are many important decisions to be made during development of the CIP programs that have adirect impact on how well the system performs for all of the required circuits. The programmer must take into consideration the circuit-specific timed functions, which require flexibility (and are generally recipe driven), versus equipment-parameter timing functions that are non–circuit specific. Errors are often made in the development of these programs that cause flexibility limitations 119
120 TE/ TT CIP return from process FIGURE 1 Simple CIP unit. PID Recirculation tank FCV TE/ TT FE/ FT CIP supply pump CIP supply to process in the application and less than ideal system performance. Programming considerations will be reviewed later in the chapter in the interest of promoting software designs that are flexible and easy for the commissioning engineer and/or end user to configure for avariety of circuit applications. Temperature Control Our basic CIP Unit model highlights asupply side resistance temperature detector (RTD), shell and tube heat exchanger, and temperature control valve (TCV) to heat and control the CIP solution temperature. In addition, there isnormally areturn side RTD tomonitor and confirm that appropriate return side temperatures are maintained. The majority of systems are equipped with some variation of this basic design. And, it is not uncommon for some pharmaceutical CIP systems to also be equipped with aheat exchanger for cooling, when the incoming purified water supply is too hot for satisfactory rinsing of proteinaceous soils which may be denatured. The RTDs can be identified in Figure 1bythe TE/TT designation. Similarly, the temperature control valve is designated by TCV. RTD Temperature Measurement Although the selection and specification of RTDs for CIP applications is not a challenging effort, there are a few considerations that should be made when PID AE/ AIT TCV Steam Conductivity sensor/analyzer Andersen
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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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Page 91 and 92: 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 142 and 143: CIP System Instrumentation and Cont
Page 164: CIP System Instrumentation and Cont
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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
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168 Franks and Seiberling FIGURE 5
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170 (A) (B) Franks and Seiberling F
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172 Franks and Seiberling FIGURE 9
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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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