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CIP Distribution Piping Systems 181 CIPS loop Primary CIPS CIPSPS CIPS to TP-2 CS T TP-1 CIPS to TP-3 Mezzanine MP-4 MP-5 2000L 2000L MP-3 1000L MP-2 1000L MP-1 1000L MP-3 to TP-3 TP-2 TP-3 Floor (ref.) CIPS to BR2 TP-2 to CIPR header BR2CIPS valves Media line to BR2 CIP supply CIPR flush line CIP return BR3CIPS Compressed air BR1CIPS BR2 BR3 Carbon dioxide BR1 T Oxygen TP-4 TP-5 BR CIPR RP1 CIP skid T CIPR Bioreactor cond manifold Floor (ref.) FIGURE 5 Illustration of integrated product and clean-in-place piping in atypical biotech facility. Abbreviations: CIP, clean-in-place; CIPR, clean-in-place return; CIPS, clean-in-place supply.
182 Lebowitz U-bend transfer panels bring many make–break connections toacentral piping termination point, providing amaximum flexibility for the production function, yet assuring controlled sanitation through CIP cleaning and further guarantee the integrity of all individual product and cleaning and/or sterilizing flow path. Figures 1and 5illustrate the transfer panel concept. The use of manually positioned transfer panel U-bends for establishing processing, CIP, and steamin-place connections in ahighly automated system requires welding permanent magnets that are encased in stainless steel rods to the center ofthe U-bend connection. Proximity switches located behind the skin of the transfer panel detect the presence or absence of aU-bend magnet between any selected pair of ports. Whereas manual “make–break” or transfer panel connections may be preferred or required between solution-containing piping and vessels and product-containing piping and vessels, valves are more typically used to control the flow within large-scale processing systems. Automatically controlled valves afford software-based control ofboth the process and cleaning program toassure proper cleaning of all vessels, equipment, and interconnecting piping. Common valves used in CIPS and CIPR distribution systems are diaphragm valves (preferred where positive barrier isolation is required), sanitary compression valves (as commonly found in the food and dairy industries), and double-seat mix-proof valves (used in CIPS and CIPR distribution to provide compact, conveniently installed double block and bleed assurance). Elimination of CIP Distribution Dead Legs Acritical factor in any CIP distribution piping system is the elimination of dead-end flow branches. While this discussion focuses on CIP distribution, the same consideration is also due to many product piping applications, for both smallscale areas, such as in transfer panels, and facility-wide distribution piping. There are three methods of preventing dead-end flow branches in piping systems. The first is by use of blocking valves at each flow branch. However, in piping systems of any substantial magnitude, it is impractical to include blocking valves at each point as needed along acomplex header. Itisespecially difficult to design a“drainable” piping system using diaphragm valves, since in ahorizontal run they must be inclined at an angle to meet this requirement and the actuators occupy considerable space and require support. Flow control generally requires the application of two valves, one in the run and other on the branch tee. Also, with each added valve in the CIPS or CIPR distribution system comes extra hydraulic static head loss, hardware/software controls, and maintenance requirements. The second method, illustrated in Figure 6, permits the elimination of deadend flow branches in CIPS and CIPR headers free of the additional blocking valves. When CIPS is brought through the header to adistribution valve and then to atwoport transfer panel (for isolation) before connection to the spray device, it fills the header downstream of the branch, and this is normally adead leg. Now consider what would happen in the CIPR header.Asflow discharges fromthe selected vessel through the transfer panel to the CIPR header toward CIPR pump RP-1, flow will back-up into the CIPR header dead-end toward MT-3. To eliminate this problem, a CIPR flush valve is added from the far end of the CIPS header beyond MT-3 to the far end of the CIPR header below MT-3. By pulsing the CIPR flush valve for brief intervals during the CIP cycle, the CIPS and CIPR header can be subjected to brief periods of flow,onacontinuous but intermittent basis throughout the full program.
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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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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: 180 return line piping, substantial
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
Page 218 and 219: Materials of Construction and Surfa
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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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