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Cleaning Validation Strategies 359 the validation and the other actives that have higher solubility can be considered qualified. Where there exists separate cleaning procedures for water soluble and water insoluble materials, aworst case active should be chosen for each. It is desirable to categorize different levels of cleaning requirements based upon the above parameters. Table 1istaken from the APIC Guide to Cleaning Validation in API plants and suggests three levels of cleaning validation (8). Using the above model, dedicated equipment for different batches would fall under LEVEL 1cleaning validation and could utilize visually clean acceptance criterion while multiple products would fall into the LEVEL 2category and require full cleaning validation. REFERENCES 1. Human Drug cGMP Notes. (Volume 6, Number 4). U.S. FDA, Center for Drug Evaluation and Research, Office of Compliance, December, 1998. (Accessed July 2007 at www.fda.gov/cder/hdn/cnotesd8.htm) 2. Guide to Inspections Validation of Cleaning Processes. U.S. FDA, Office of Regulatory Affairs. (Accessed July 2007 at www.fda.gov/ora/inspect_ref/igs/valid.html) 3. APIC Cleaning Validation in Active Pharmaceutical Ingredient Manufacturing Plants. APIC “The Active Pharmaceutical Ingredients Committee,” aSector Group within the European Chemical Industry Council, 1999:7. (Accessed July 2007 at www.apic.cefic. org/pub/4CleaningVal9909.pdf) 4. Brunkow R, Delucia D, Haft S, et al. Cleaning and Cleaning Validation: ABiotechnology Perspective. Bethesda, MD: PDA, 1996:108. 5. LeBlanc DA. Is adirty swab avisually clean failure. Cleaning Memos: Volume 3January 2003 to December 2003. San Antonio: Cleaning Validation Technologies, 2003. 6. Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation, PI 006-2, Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-Operation Scheme (PIC/S). Geneva, Switzerland, 2001:21. (Accessed July 2007 at www.picscheme.org/publis/ recommandations/PI%200062%20Recommendat_121CF0.pdf) 7. Pharmaceutical Cleaning Validation Method References for Alconox, Inc. Detergents. White Plains, NY: Alconox, Inc. (Accessed July 2007 at www.alconox.com/static/ section_top/gen_cleanval.asp) 8. APIC Cleaning Validation in Active Pharmaceutical Ingredient Manufacturing Plants. APIC “The Active Pharmaceutical Ingredients Committee,” aSector Group within the European Chemical Industry Council, 1999:9. (Accessed July 2007 at www.apic.cefic. org/pub/4CleaningVal9909.pdf) 9. LeBlanc DA. Analytical methods for cleaning validation. Validated Cleaning Technologies for Pharmaceutical Manufacturing. Boca Raton, FL: Interpharm/CRC, 2000. 10. Good Manufacturing Practices—Cleaning Validation Guidelines. Health Canada, Health Products and Food Branch Inspectorate, 2001:7. (Accessed July 2007 at www. hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/compliconform/cleaningnettoyage_e.pdf) 11. Annex 15 to the EU Guide to Good Manufacturing Practice, Qualification and Validation. European Commission, Enterprise Directorate–General, Working Party on Control of Medicines and Inspections. Brussels, 2001:8–9. (Accessed July 2007 at www.picscheme. org/publis/recommandations/PI%20006-2%20Recommendat_121CF0.pdf) 12. Bismuth G, Neumann S. Cleaning Validation: APractical Approach. Boca Raton, FL: CRC Press, 2000:54–5. 13. Davis M, Stefanou S, Walia G. Ion mobility spectrometry speeds cleaning validation. Pharmaceutical Processing. Rockaway, NJ: Advantage Business Media, 2003. 14. Melling P, Thomson M, Mehta N, Goenaga-Polo J, Hernández-Rivera S, Hernández D. Development of an in-situ spectroscopic method for cleaning. Spectroscopy 2003; 18(4):13–9. Advanstar Communications, Iselin, NJ.
360 15. Karen A. Clark, Product Manager, Anatel Corporation. Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing. Newsletter. Technical Archive. ISPE Boston Chapter, October 2000 (www.ispe.org/boston/articles/arch10- 1000.htm) 16. Goenaga-Polo J, et al. Development of an in-situ spectroscopic method for cleaning validation using mid-IR fiber-optics. BioPharm 2002. 17. Mettler HP. Personal correspondence with author. Visp, Switzerland, 2005. 18. O’Brien RW, Voss JM. In: Kenneth A, Carmen W, Vincent W, eds. Cleaning and Validation of Cleaning in Pharmaceutical Processing: A Survey. Boca Raton, FL: Interpharm/CRC Press, 1999:221–50. BIBLIOGRAPHY Lankford Validation of analytical procedures, ICH-Q2A. In: International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use. Geneva, 1995. Recommendations on Validation Master Plan Installation and Operational Qualification Non- Sterile Process Validation 1July 2004 PI 006-2 Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-Operation Scheme PIC/S, Geneva. (www.picscheme.org/ BAK/docs/pdf/PI%20006-2%20Recommendation%20on%20 Validation%20Master%20Plan.pdf)
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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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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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Page 348 and 349: 18 Commissioning and Qualification
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Page 371 and 372: 350 Lankford All analytical methods
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Page 391 and 392: 370 … C.02.004 … 4. Pipework sy
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Page 395 and 396: 374 TABLE 1 Directives of the Europ
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Page 406 and 407: Index 385 Flow alarm, no-return, 30
Page 408 and 409: Index 387 Off skid instrumentation,
Page 410 and 411: Index 389 Rising stem valves, 223-2
Page 412: Index 391 [Troubleshooting] spray c
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