Index
Note: Page numbers followed by “f” and “t” refer to figures and tables, respectively.
A
maximum adhesion resistance moment,
61–62
particle adhesion models on rough surfaces,
62–64
Airborne molecular contaminants (AMCs),
process of developing standards,
118
Arbitrary function generator (AFG),
157–158
Association for the Advancement of Medical Instrumentation (AAMI),
107t–108t
Association of Southeast Asia Nations (ASEAN),
87
Atom probe tomography,
31
Auger electron spectroscopy,
31
B
Building and facilities,
96–100
C
Carrier density imaging,
33
Cationic contaminants,
1–2
CFDA Pharmaceutical Standard,
121–123
Chinese State Food and Drug Administration (SFDA),
120
Cleanroom, aseptic gowning for,
109f
Cleanroom separation/segregation,
102–106
Cleanroom standards, interpretation of,
124–126
communicate and clarify,
126
Cobalt diffusion in silicon,
14–15
Current good manufacturing practices (cGMPs),
86–87
D
Deep-level transient spectroscopy (DLTS),
33
Differential pressure concept,
104
Diffusion coefficient of a solute impurity,
13–16
Displacement airflow concept,
104–106
maximum adhesion resistance moment,
63t
Droplet-assisted laser cleaning (DALC),
156–167
E
Effective washing of hands, steps for,
108f
Electron beam–induced current microscopy,
33, 38
Electron energy-loss spectroscopy,
31
European Economic Community (EEC),
87
Experimental resuspension data,
72–77
F
Figures and flowcharts,
127
Force and acceleration sensors,
165–166
Fresh air determination,
118
G
Gas-phase reactions,
35–36
Global Society for Contamination Control (GSFCC),
122
Glow discharge mass spectroscopy,
31
Goldschmidt diameters,
13
Good manufacturing practices (GMPs) in pharma manufacturing,
85, 92, 121
building and facilities,
96–100
monitoring system, need for,
87–89
locations to be monitored,
89
monitoring key parameters,
87–89
organization and personnel,
93–96
personal responsibilities of employees,
96
production department,
94–95
responsibilities of various departments,
94–96
shared responsibilities between QC head and production department head,
95–96
quality management systems in,
89–93
pharmaceutical quality system,
89–92
product quality review,
93
quality control (QC),
92–93
Gowning/change room control and configuration,
107–108
H
Heating, ventilation, and air conditioning (HVAC) system,
100–108
cleanroom separation/segregation,
102–106
design and function of,
102f
gowning/change room control and configuration,
107–108
sanitation and personal hygiene,
107
shell-type contamination control concepts,
105f
unidirectional airflow pattern,
105f
airflow velocity and changes per hour,
110–111
filter integrity test (DOP/PAO Test),
115–116
fresh air determination,
118
passive air sampling,
114
temperature and humidity uniformity test,
118
High performance materials,
151–152
Humidity uniformity test,
118
Hydrodynamic forces,
65–67
I
Inductively coupled plasma mass spectrometry (ICP-MS),
31
Information, conveying,
127
figures and flowcharts,
127
sentences versus figures/flowcharts,
127
Infrared (IR) lasers,
155
Institute of Environmental Science and Technology (IEST),
107t–108t, 125
Intentionally ambiguous wording,
112–113
International Organization for Standardization (ISO),
107t–108t
and American National Standards Institute (ANSI),
118–120
for cleaning and contamination control,
120
International Technology Roadmap for Semiconductors (ITRS),
1t, 2
communicate and clarify,
126
Intragranular defects,
32–33
ISO 14644-10,
J
maximum adhesion resistance moment,
63t
K
Kefauver–Harris Amendment,
86–87
L
Laser-based cleaning techniques,
152–156
laser shock cleaning (LSC),
154–155
optohydrodynamic cleaning process,
156
Lifetime imaging techniques,
33
Litron Nd:YAG lamp-pumped laser,
157
M
Manufacturing operations,
97–98
Mass spectroscopy techniques,
31
Medical fitness examination,
93–94
Metallic contaminants,
characterization techniques,
29–34
contamination sources,
23–29
ionic contamination,
28–29
metal impurities and particles,
23–28
ionic contamination,
36–38
metal particles and trace metal impurities,
34–36
Metastable defects,
15–16
Microelectromechanical systems (MEMS),
27–28
maximum adhesion resistance moment,
63t
N
Nanotechnology products,
12
Neutron activation analysis (NAA),
31–32
Nordson controller (DCON),
158
Nordson PICO valve (LV-20),
158
O
Optohydrodynamic cleaning process
P
Particle cleanliness levels for surfaces,
Particle detachment,
57–68
maximum adhesion resistance moment,
61–62
particle adhesion models on rough surfaces,
62–64
hydrodynamic forces,
65–67
Particle resuspension from surfaces,
55–56
resuspension experiments,
68–77
experimental resuspension data,
72–77
wind tunnel and duct flow characteristics,
68–71
theoretical model and experimental data for,
77–79
Particle–surface interaction,
57
Pharmaceutical Inspection Convention (PIC),
87
Photoluminescence (PL) imaging,
33
Physical barrier concept,
106
Preexponential factor,
13–15
Process related metal contaminants,
30
Product quality review,
93
Production department,
93–95
Q
Quality control (QC) department,
93, 95
Quality control (QC) laboratories,
99
Quality management systems in GMP,
89–93
pharmaceutical quality system,
89–92
product quality review,
93
quality control (QC),
92–93
R
Resuspension experiments,
68–77
experimental resuspension data,
72–77
wind tunnel and duct flow characteristics,
68–71
Retrograde melting,
19–21
S
Sanitation and personal hygiene,
107
Scanning electron microscopy (SEM),
158–159
Secondary ion mass spectroscopy (SIMS),
31
Semiconductor Equipment and Materials International (SEMI),
Semiconductor silicon wafer processing,
1–2
Sentences versus figures/flowcharts,
127
Shell-type contamination control concepts,
105f
Silicon, cobalt diffusion in,
14–15
Site development plan,
96–97
Solubility of solute impurity,
16–23
chronic emergency standards,
109–110
conveying the information,
127
figures and flowcharts,
127
sentences versus figures/flowcharts,
127
evolution of standards,
123
China Food and Drug Administration (CFDA),
120–123
interpretation of cleanroom standards,
124–126
perfection versus reality,
110
intentionally ambiguous wording,
112–113
coping with standards,
129
Stokes–Einstein–Sutherland formula,
14
Surface photovoltage (SPV) method,
33
Synchrotron-based X-ray fluorescence techniques,
32–33
T
Temperature uniformity test,
118
Total reflection X-ray fluorescence spectrometry (TXRF),
31
Trace element content of various plastics,
23, 26t
U
United States Federal Food, Drug, and Cosmetic Act of 1938,
86
United States Food and Drug Administration (FDA),
107t–108t
involvement in standards,
111
V
Vapor-phase decomposition droplet collection (VPD-DC),
31
passive air sampling,
114
W
Wind tunnel and duct flow characteristics,
68–71
X
X-ray beam-excited scanning optical luminescence microscopy,
32–33
X-ray beam-induced current,
32–33
X-ray fluorescence microscopy,
32–33
X-ray photoelectron spectroscopy,
31