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CIP System Instrumentation and Controls 135 Step length Step length register Sequence discription FV1414 FV1415 FV1416 FV1482 Reset Step Hex bit pattern Hex bit pattern register Step FIGURE 9 Device sequence matrix chart (bioreactor vessel and legs). Step decription clean all product contact surfaces (of each device) or to maintain proper hydraulic balance among various circuit flowpaths. The device sequence matrix functions much like that of the CIP unit matrix except that it may cycle through aparticular sequence many times during asingle CIP Unit Program sequence. Again, this documentation provides guidance to the programmer about the needed flexibility to adjust setpoints as well as sequence steps easily and quickly at commissioning time. An example is shown in Figure 9. Avoiding Some Typical Programming Pitfalls As with any technology, there have been many different approaches to software design by different parties over the years. Some approaches have been more successful than others, and this author has attempted to identify anumber of design methods or concepts that (in my opinion) have met with undesirable
136 Andersen complications or problems. Most certainly, there are valuable lessons learned from understanding what has been previously attempted in the past. Understanding the CIP Process Although this may seem very obvious, this author feels the need to point out the fact that there isnosubstitute for utilizing software developers who have previous design and commissioning experience with CIP.Oftentimes, the development of the CIP code will be more complex than that of the process code and previous experience will make a substantial difference in the quality of the software application. Many pharmaceutical users choose their system integrator with the process controls in mind and the CIP portion of the programming effort is just an afterthought. One should not underestimate the design effort required for aCIP application. The pharmaceutical user may have to spend considerable time in locating asystem integrator with this type of experience as many do not have it. Overly Complex Software Sometimes the end user or the system integrator utilizes software concepts that are far more complex than necessary. This increases project costs and time during design, commissioning, and validation. Some examples that this author has seen are noted in the following paragraphs. It is always recommended during the design process to perform some reality checks to ensure that the design is not unnecessarily complicated. Acquiring the Flow Path One must provide appropriate software interlocks such that aCIP process cannot be activated for aparticular circuit if part of that circuit is currently in production use (or is in some other state when CIP would be undesirable). In other words, the flowpath to be cleaned must be acquired for CIP in order to clean it. On the other hand, there have been applications developed in the past where every segment of pipe between any automation devices or major pieces of equipment is treated as a separate entity and must be acquired individually in software before CIP can be activated. This level of complexity is unnecessary and burdensome to the production operators who must use the system. The Process Controls in the CIP System Most CIP applications involve asingle CIP unit that supports the cleaning of several process areas or “cells.” Oftentimes the user has separate controllers for these process cells, particularly if the controlsystem is DCS based. Therehave been some approaches where parts of the higher level supervisory code for the CIP unit aredesigned as part of the process cell and located in that respective controller.This can lead to redundant code that must be developed, tested, commissioned, and validated in each process cell controller. Itisthis author’s recommendation that all of the control code for the CIP unit be located in the CIP controller in order to minimize complexity. The device sequencing (or valve sequencing) code (for the circuit being cleaned), may, onthe other hand may be better located within the individual process cell controller. This last decision is really application specific and needs to be analyzed on acase by case basis.
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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
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-
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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
Page 191 and 192: 170 (A) (B) Franks and Seiberling F
Page 195 and 196: 174 The variables that impact the r
Page 197 and 198: 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
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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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