Untitled

More documents

Recommendations

Info

Cleanable Solids Processing Equipment and Systems 259 FIGURE 1 Typical spray balls. Source: Courtesy of Electrol Specialities Company. the full product path to ensure cleanliness. Apart washing cabinet may be set up and used for cleaning the fluid atomizers. Rotary atomizers generally require disassembly and manual cleaning or cleaning in aparts washer. Specific Spray Dryer Design Considerations Headplate/Air Inlet Spray dryers use an air inlet distribution system installed in the dryer headplate to control hot air distribution into the dryer body. This is sometimes referred to as an air swirler. The air swirlers come in avariety of sizes and configuration to allow Rotary atomizer Two-fluid nozzle co-current mode Two-fluid nozzle fountain mode FIGURE 2 Atomizers (including rotary and two-fluid). Source: Courtesy of GEA Niro Inc.
260 Forder control of the drying process. Hot, drying gas passes through the air swirler on its way into the drying chamber on adryer. Despite the high air velocities through these air inlet devices, powders can “creep” into the air inlet pathway during operation. Attention needs to be paid to ensure that the air swirler is adequately cleaned during CIP.This can be achieved by installing spray ball or spray rings into the headplate and allowing cleaning fluids to contact and clean the air swirler. Some dryers may incorporate aremovable air swirler or diffusion plate in the drying airflow inlet. The swirler devices in these applications use apin to locate and hold them in place in the headplate. There isapossibility of powder to eventually accumulate in the gaps between the swirler and the inlet path. This powder is difficult to clean unless the swirler is removed and the powder manually scrubbed off. In commercial equipment used for routine good manufacturing practices, the final design of the swirler should be fixed and the air swirler should be permanently installed and welded in place to eliminate any gaps or crevices. Spray dryer installations will require isolation valves and proper pipe slope to facilitate CIP removal of dry powder fromall product contact surfaces. An isolation valve should be located as close to the top of the spray dryer as possible to prevent cleaning solutions upstream of the dryer body. This valve will prevent solutions from coming into contact with upstream heaters or air filters. Additionally, downstream isolation valves should be incorporated to protect final filters. The valves are closed during cleaning and prevent cleaning solutions from entering the final filter housing or upstream air filter systems. Isolation valves should be of sanitary design and typically of abutterfly design to minimize drying gas flow interruption. Dryer Body Explosion Equipment The actual dryer body will be of sufficient length to ensure complete drying of all liquid droplets before they reach the bottom areaofthe dryer.Most aqueous dryers will require some type of explosion suppression/containment system (Fig. 3) to prevent loss of product or life in the event of aconflagration. In cases where these suppression systems are added to the walls of the dryer body ensure that asanitary fitting is used with aminimum amount of offset from the dryer wall. Fike uses a suitable sanitary design to attach both the suppression system and the pressure sensor to the wall of the dryer (Fig. 4). Dryer Gaskets To facilitate fabrication, the dryer body will typically come in two parts, an upper and lower half. Most nonpharmaceutical fabrications will use acommon flange and gasket to combine the two halves of the dryer. While simple and relatively cheap, these flange gaskets are difficult to clean and accumulate residues. GEA Niro offers an alternate sanitary O-ring gasket to combine the two halves of adryer which eliminates the flange and provides asanitary seal between the dryer parts. The O-ring seals the two halves of the dryer and eliminates the gaps of the standard flange/gasket configuration. GEA Niro Sanitary Seal Additional area ofdesign concern to ensure proper cleaning includes the use of sanitary instrumentation. Temperature sensors (e.g., dryer outlet temperature) should incorporate a sanitary well-type design allowing cleaning solutions to
Page 2:
Clean-In-Place for Biopharmaceutica
Page 13 and 14:
Informa Healthcare USA, Inc. 52 Van
Page 15 and 16:
iv Preface period, the industry rec
Page 18 and 19:
Preface iii Contents Acknowledgment
Page 20:
Contributors Barry J. Andersen Seib
Page 23 and 24:
2 the last step of abatch manufactu
Page 25 and 26:
4 Seiberling The vessel capacity ma
Page 27 and 28:
6 Seiberling any two ports. For pur
Page 29 and 30:
8 AWFI (or Any Water) Supply If the
Page 31 and 32:
10 Seiberling program, and through
Page 33 and 34:
12 Seiberling (380 L) for the solut
Page 35 and 36:
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 46 and 47:
Page 48 and 49:
Page 50 and 51:
Page 52 and 53:
Page 54 and 55:
Page 56 and 57:
Page 58 and 59:
Page 60 and 61:
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 68 and 69:
Page 70 and 71:
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 and 88:
66 pH 13 pH 7 pH, %, Excess water h
Page 89 and 90:
68 dramatically increased rinsing t
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-
Page 140 and 141:
7 CIP System Instrumentation and Co
Page 142 and 143:
CIP System Instrumentation and Cont
Page 144 and 145:
Page 146 and 147:
Page 148 and 149:
Page 150 and 151:
Page 152 and 153:
Page 154 and 155:
Page 156 and 157:
Page 158 and 159:
Page 160 and 161:
Page 162 and 163:
Page 164:
Page 167 and 168:
146 Lebowitz should be considered f
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 189 and 190:
Page 191 and 192:
170 (A) (B) Franks and Seiberling F
Page 193 and 194:
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
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
Page 220 and 221:
Page 222 and 223:
Page 224 and 225:
Page 226 and 227:
Page 228 and 229:
Page 230 and 231: Materials of Construction and Surfa
Page 232 and 233: 12 Cleanable In-Line Components INT
Page 234 and 235: Cleanable In-Line Components 213 &
Page 236 and 237: Cleanable In-Line Components 215 Al
Page 238 and 239: Cleanable In-Line Components 217 Ex
Page 240 and 241: Cleanable In-Line Components 219 FI
Page 242 and 243: Cleanable In-Line Components 221 Tr
Page 244 and 245: Cleanable In-Line Components 223 it
Page 250 and 251: Cleanable In-Line Components 229 eq
Page 252 and 253: Cleanable In-Line Components 231 Th
Page 254 and 255: Cleanable In-Line Components 233 co
Page 256 and 257: 13 Cleanable Liquids Processing Equ
Page 258 and 259: Cleanable Liquids Processing Equipm
Page 268 and 269: 1-9 CIPS 2 Plant steam CIPS valves
Page 276: Cleanable Liquids Processing Equipm
Page 279: 258 8. Projectile-type thermometer
Page 283 and 284: 262 Forder FIGURE 5 Pharmaceutical
Page 285 and 286: 264 Forder FIGURE 7 Pharmaceutical
Page 287 and 288: 266 FIGURE 9 Pleated filter cartrid
Page 289 and 290: 268 FIGURE 12 Disassembledstainless
Page 291 and 292: 270 The acid wash of 85% phosphoric
Page 293 and 294: 272 FIGURE 17 Sanitary Vbenders. So
Page 295 and 296: 274 one each for the upper, central
Page 297 and 298: 276 CIP VS. TRADITIONAL BOIL-UP MET
Page 299 and 300: 278 Cerulli were not designed to be
Page 301 and 302: 280 by large flanged connections fo
Page 303 and 304: 282 CIP header Once thru CIP soluti
Page 305 and 306: 284 Nozzle Use A Manway B Agitator
Page 307 and 308: 286 3" Stub end w/150# flange 2A 1
Page 309 and 310: 288 In most cases, the pressure dro
Page 311 and 312: 290 CIP fluids Process fluids 1 2 3
Page 313 and 314: 292 A Vent to atm. B M Conical drye
Page 315 and 316: 294 One of the designer’s first t
Page 318 and 319: 16 CIP System Troubleshooting Guide
Page 320 and 321: CIP System Troubleshooting Guide 29
Page 330 and 331:
CIP System Troubleshooting Guide 30
Page 332 and 333:
Page 334 and 335:
Page 336 and 337:
17 Waste Treatment for the CIP Syst
Page 338 and 339:
Waste Treatment for the CIP System
Page 340 and 341:
Page 342 and 343:
Page 344 and 345:
Page 346 and 347:
Page 348 and 349:
18 Commissioning and Qualification
Page 350 and 351:
Commissioning and Qualification 329
Page 352 and 353:
Page 354 and 355:
Page 356 and 357:
Page 358 and 359:
Page 360 and 361:
Page 362 and 363:
Page 364 and 365:
Page 366:
Page 369 and 370:
348 & Sterilization refers to the r
Page 371 and 372:
350 Lankford All analytical methods
Page 373 and 374:
352 should be based upon scientific
Page 375 and 376:
354 Lankford acleaning validation p
Page 377 and 378:
356 In summary, TOC analysis is are
Page 379 and 380:
358 In-Situ In-situ measurement tec
Page 381 and 382:
360 15. Karen A. Clark, Product Man
Page 383 and 384:
362 Actually, most countries revise
Page 385 and 386:
364 §211.100 Written procedures; d
Page 387 and 388:
366 §211.186 Master production and
Page 389 and 390:
368 Equipment Regulation C.02.005 T
Page 391 and 392:
370 … C.02.004 … 4. Pipework sy
Page 393 and 394:
372 5.20 Schedules and procedures (
Page 395 and 396:
374 TABLE 1 Directives of the Europ
Page 397 and 398:
376 TABLE 5 Cleanability Performanc
Page 400 and 401:
Index Accessibility, 28 Acid cleane
Page 402 and 403:
Index 381 CIP supply flow troublesh
Page 404 and 405:
Index 383 [Cleaning cycle sequences
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
show all

Untitled

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?