Untitled

386
International Society for Pharmaceutical
Engineering, 368–370
Pharmaceutical Inspection Convention,
369–370
IQ. See installation qualification.
Isolation equipment CIP, 289–290
Iterations, cleaning validation and,
353–354
Japanese regulations, 366–367
Joints
fabrication of, 214
non-permanent, 214–215
Large-high volume dual CIP skid, 112
Layout of process facility, 26–28
accessibility, 28
return flow motivation, 28
Level control, 124–127
bubble tube level transmitter, 125–126
magneteostrictive level transducer, 125
other sensing technologies, 126–127
Loop method. See Slipstream chemical
injection method
Loops, 184–186
sizing of, 186–187
Low flow rate, 306
Low level CIP skid water tank problems,
309–310
Machining, 205–206
Magnetostrictive level transducer, 125
Manual COP cleaning, 15–16
Marstenitic steel, 195
Mass flowmeter, 123
Master planning, cleaning validation, 349
Master recipes
acid and alkaline cleaners, 87–88
aqueous based cleaning program,
84–87
solvent-assisted, 90
solvent-based cleaning programs,
88–90
Matrix charts development, 132–135
device sequences, 133–135
recipe definition, 132–133
Measuring instruments, cleaning agent
solution dilution and, 157 -158
Mechanical action, control of, 123–124
Mechanical polishing, 201, 213
Index
Mechanical problem resolution, valve
sequencing and, 137–138
Meter based chemical delivery, 153
Microbial influenced corrosion, 198
Mineral acids, 204
Mix proof groups, transfer panels vs.,
30–31
Mixing tanks, 249–250
Mixing, 8–9
Mix proof valves, 238–244
dedicated production process,
240–241
diaphragm-type, 243
rising stem, 242–243
U-bend transfer panel combinations,
238–240
Motor-operated diaphragm pumps, 150
Multi tank CIP configuration, 104–105
CIP recirc tank, 104–105, 106–114
Multiple leg bioreactors, 244–249
Multiple tank configurations, 104
Multi-port diaphragm valves, 226–227
Multi-product equipment, vs. single,
cleaning validation, 358–359
Multi-tank skid, 96
Net positive suction head (NPSH), 175
Neutral cleaners, 56–57
Non-governmental organizations,
368–372
International Conference on Harmonization
(ICH), 370–372
International Society for Pharmaceutical
Engineering, 368–370
Nonionic chemical structure, surfactants
and, 61–62
Non-permanent joints, 214–215
Non-permanent joints
Acme threaded connections, 214–215
cam-type, 214–215
clamp-type, 215
flanged, 214–215
gasket extrusion, 216
sealing materials, 215–216
Nonspecific methods, cleaning validation
and, 355–356
No-return flow alarm, 307–308
Nozzles, solid charge, 286
NPSH. See Net positive suction head