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Composition of Cleaning Agents for Pharmaceutical Industries 67 FIGURE 21 Sequestering agents disturb the surface of crystals during their growth phase. Without sequestration Hard, adherent crystals FIGURE 23 Undisturbed calcite crystals. FIGURE 25 Water hardness in the form of calcite crystals on asurface. Microcrystal FIGURE 22 Polyacrylates bind microcrystalsthus retarding the formation of scale. With sequestration Soft, powdery "sludge" FIGURE 24 Crystallization disturbed by presence of sequestering agent. FIGURE 26 Amorphous water hardness sludge on asurface.
68 dramatically increased rinsing times and high-rinse water consumption. The formation of foam also can affect level control equipment and can cause severe damage by cavitation in centrifugal pumps. Foam is created either by foaming surfactants, production residues, or from the reaction between cleaner and soil. Defoamers could be used to alleviate the problem. They are predominantly hydrophobic substances and work at the interfacial areas of the cleaning solution, preventing the formation offoam. However, ironically, their disadvantage is their hydrophobia for they are not water soluble, difficult to integrate into cleaner formulations, and aproblem to rinse. Typical substances used as defoamers are paraffin oil, silicones, fatty acids, and fatty alcohols with very short EO or PO chains, etc. However, the last substance class offers a solution to the problem. By combining longer hydrophilic molecules with relatively short EO-chains or by introducing PO into the EO-chain, it is possible to produce surfactants that reach their insolubility (so-called “cloud point” because the clear solution becomes cloudy at this temperature) at a temperature far below the intended cleaning temperature. For example, asurfactant with acloud point at 308 Cwill become increasingly hydrophobic at temperatures above 308 C. This effect produces foam-controlling properties and the surfactant does not foam anymore. Even more, it acts increasingly as adefoamer for all other substances that might be present and cause foaming. When finally rinsing with cold water ( ! 308 C), the substance becomes increasingly more soluble thus facilitating its removal from surfaces (Fig. 27). Oxidizing Agents Oxidizing agents, such as peroxides and hypochlorites, assist in decomposing carbonized residues and insoluble high-molecular compounds. They also can destroy dyes or discoloring agents providing ableaching effect. When considering the use of such chemicals as cleaning boosters added to acleaning solution, it is essential to be aware of the risk of chemical attack. Although hypochlorites are extremely efficient, they are also highly corrosive towards certain materials and can cause pitting corrosion on stainless steel as well as attacking such sealing materials as rubber and plastics. Oxidizing agents based on hydrogen peroxide show agood efficacy, but they are less likely to attack equipment. FIGURE 27 The cloud point of anonionic surfactant. Rosner
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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
Page 37 and 38: 16 Seiberling products in asingle f
Page 39 and 40: 18 Seiberling The literature began
Page 42 and 43: 2 Project Planning for the CIPable
Page 44 and 45: Project Planning for CIPable Facili
Page 62 and 63: 3 Water for the CIP System Jay C. A
Page 64 and 65: Water for the CIP System 43 FIGURE
Page 66 and 67: Water for the CIP System 45 of clea
Page 72: Water for the CIP System 51 WATER U
Page 75 and 76: 54 Time Temperature FIGURE 2 The cl
Page 77 and 78: 56 Classification of Cleaners by pH
Page 79 and 80: 58 [mg/sec] Cleaning velocity C v ,
Page 81 and 82: 60 + - Na O O C CH 2 CH 2 (CH 2 ) n
Page 83 and 84: 62 CH3 -(CH2 ) n -CH2 -O -CH2 -CH2
Page 85 and 86: 64 B C D E FIGURE 17 Capability of
Page 87: 66 pH 13 pH 7 pH, %, Excess water h
Page 91 and 92: 70 desorption. If the affinity is v
Page 93 and 94: 72 & Cleaning procedure inthe case
Page 95 and 96: 74 effort being performed relativel
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-
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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
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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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