Untitled

388
Process controls, CIP system instrumentation
and controls programming
concepts and, 136
Process function, CIP skid, 112–114
Process trains, 236–238
bioreactors, 244–249
blenders and mixing tanks, 249–250
transfer line
filter housing CIP, 252–253
U-bend transfer panels, 236–238
split flow considerations, 237–238
valve pulsing, 237–238
Product rinse forward, 9
Programmable logic controller (PLC),
distributed control system
(DCS), 31
hybrid, 131–132
Programming concepts, CIP System
instrumentation and controls, 132
Progressive cavity pumps, 229–231
Proportional integral derivative
(PID), 121
loop response, 303
Protein foams, 86–87
Proximity sensors, 220–221
Pumped return flow, 177–178
Pumps, 228–231
centrifugal, 229
CIPR, 7
double diaphragm, 231
failures of, 300–301
peristaltic, 231
progressive cavity, 229–231
Qualification, CIP system, 327–345
Queuing process, 137
Reactor systems, 277–280
Reactor vessel, 283–284
Recipe, definition of, 132–133
Recirculated CIP program, 75–77
example of, 76
single-pass vs., 76–77
Recirculating CIP unit model, illustration
of, 119
Recirculation tank, circuit hydraulic
balance and, 310–311
water addition, 311
Index
Recycle operation, 100–101
Redundancy requirements, CIP facility
project planning and, 25–26
Regulations, 361–376
Canada, 364–366
compliance with, 372
European Standards for Biotechnology,
374–376
European Union, 363–364
good manufacturing practices, 361
implementation of, 372–374
Japan, 366–367
non-governmental organizations,
368–372
other countries, 367–368
United States and FDA, 362–363
Remote instrumentation, 129
Repassivation, 206
Report generation, CIP System instrumentation
and control quality
tools, 140
Residue limits, cleaning agent, 351–353
Residue removal, construction materials
and, 207
Return flow check, 80, 127–128
conductivity sensing element, 127
other types, 128
tuning fork level switch, 127–128
Return flow motivation, 28, 175–180
Return flow problems, 307
insufficient return flow, 308
no-return flow alarm, 307–308
vortex formation, 308
Return temperature alarm, 303–304
Reverse osmosis (RO), 10
Riboflavin testing, 294
Rinse forward, 9
Rinse phase, 74, 79–80
criteria for, 80
final, 75, 83
return flow, 80
selection of, 79
temperature requirements, 79
volume and duration, 80
Rinse sampling techniques, 357
Rinse
cleaning programs and, 10–12
prewash, 10
Rising stem mix proof valves, 242–243
two tanks in atrain, 242–243