Index

Note: Page numbers followed by “f” and “t” refer to figures and tables, respectively.

A

Ablative laser cleaning, 152–154
Activation energy, 13–15
Adhesion forces, 57–64
maximum adhesion resistance moment, 61–62
particle adhesion models on rough surfaces, 62–64
Airborne molecular contaminants (AMCs), 2
Air handling facilities, 101, 119
Alkaline earths, 11–12
Aluminum, 11–12
American National Standards Institute (ANSI), 107t–108t, 118–120
American Society for Testing and Materials (ASTM), 107t–108t, 115–118, 124
process of developing standards, 118
specific standards, 115–117
standards, 115
types of, 116t
Arbitrary function generator (AFG), 157–158
Arrhenius equation, 13, 17
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

Barium, 11–12
Borosilicate glass, 23
Building and facilities, 96–100
ancillary area, 99–100
lighting, 100
production area, 99
QC area, 99
storage area, 98

C

Calcium, 11–12
Carrier density imaging, 33
Cationic contaminants, 1–2
China Food and Drug Administration (CFDA), 107t–108t, 120–123
CFDA Pharmaceutical Standard, 121–123
Chinese State Food and Drug Administration (SFDA), 120
Cleanroom, aseptic gowning for, 109f
Cleanroom classification, 101–102
Cleanroom separation/segregation, 102–106
Cleanroom standards, interpretation of, 124–126
communicate and clarify, 126
IEST-STD-CC1246E, 125
ISO 14644, 125
MIL-STD-1246, 125
product surface, 125
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
DMT model, 60–63
maximum adhesion resistance moment, 63t
DOP/PAO test, 115–116
Droplet-assisted laser cleaning (DALC), 156–167
discussions, 163–167
experimental setup, 157–159
force and acceleration measurements, 165–166, 165f
results, 159–163

E

Effective washing of hands, steps for, 108f
Electron beam–induced current microscopy, 33, 38
Electron energy-loss spectroscopy, 31
Emergencies, 114
Emergency standards, 109–110
Energy dispersive X-ray spectroscopy (EDX), 158–159, 163, 163t
European Economic Community (EEC), 87
Experimental resuspension data, 72–77
particle size, 72–74
relative humidity, 74–75
time dependency, 75–76

F

Figures and flowcharts, 127
Filter integrity test (DOP/PAO Test), 115–116, 117f
Filter leak test, 111, 113f
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
ancillary area, 99–100
lighting, 100
production area, 99
QC Area, 99
storage area, 98
components of, 89, 90t
development of, 86–87
GMP guidelines, 87–93
monitoring system, need for, 87–89
locations to be monitored, 89
monitoring key parameters, 87–89
ways to monitor, 89
organization and personnel, 93–96
personal responsibilities of employees, 96
production department, 94–95
QC department, 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 assurance, 92
quality control (QC), 92–93
Gowning/change room control and configuration, 107–108

H

Hall effect, 33–34
Hard disk drive, 1–2
Heating, ventilation, and air conditioning (HVAC) system, 100–108
cleanroom classification, 101–102
cleanroom separation/segregation, 102–106
design and function of, 102f
gowning/change room control and configuration, 107–108
importance of, 100–101
personnel training, 106–107
sanitation and personal hygiene, 107
shell-type contamination control concepts, 105f
unidirectional airflow pattern, 105f
validation of, 108–118
acceptance criteria, 118
active air sampling, 113
airflow pattern, 109–110
airflow velocity and changes per hour, 110–111
filter integrity test (DOP/PAO Test), 115–116
filter leak test, 111
fresh air determination, 118
particle count test, 111
passive air sampling, 114
pressure difference, 117
recovery test, 117
surface monitoring, 114–115
temperature and humidity uniformity test, 118
viable monitoring, 111–115
Heating the air, 100–101
Hertz model, 58–60
High efficiency particulate air (HEPA) filters, 101, 109–111, 115–116
High performance materials, 151–152
Humidity uniformity test, 118
Hydrodynamic forces, 65–67
Hygrometer, 117

I

IEST-STD-CC1246E, 2, 125
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
ISO standards, 119
for cleaning and contamination control, 120
ISO 14644, 121t
International Technology Roadmap for Semiconductors (ITRS), 1t, 2
Interpreting standards, 124–126
communicate and clarify, 126
product surface, 125
Intragranular defects, 32–33
Ionic contamination, 28–29, 36–38
Ionic metals, 11–12
Iron, 11–12
ISO 14644-10, 2

J

JKR model, 59–60, 62–63
maximum adhesion resistance moment, 63t
Joule effect, 151–152

K

Kefauver–Harris Amendment, 86–87

L

Laser shock cleaning (LSC), 154–155, 154f
Laser-based cleaning techniques, 152–156
ablative laser cleaning, 152–154
laser shock cleaning (LSC), 154–155
optohydrodynamic cleaning process, 156
wet laser cleaning (WLC), 155–156
Lifetime imaging techniques, 33
Lighting facilities, 100
Litron Nd:YAG lamp-pumped laser, 157

M

Manufacturing operations, 97–98
Mass spectroscopy techniques, 31
Medical fitness examination, 93–94
Metallic contaminants, 1
behavior, 11–23
diffusion, 13–16
solubility, 16–23
characterization techniques, 29–34
cleanliness levels, 2–11
contamination sources, 23–29
ionic contamination, 28–29
metal impurities and particles, 23–28
impact of, 34–38
ionic contamination, 36–38
metal particles and trace metal impurities, 34–36
Metastable defects, 15–16
Microelectromechanical systems (MEMS), 27–28
MIL-STD-1246, 125
Miniaturization, 12
MP model, 61–63
maximum adhesion resistance moment, 63t

N

Nanotechnology products, 12
Neutron activation analysis (NAA), 31–32
Niobium, 11–12
Nordson controller (DCON), 158
Nordson PICO valve (LV-20), 158
Nozzle pulse time, 158

O

Optical microscopy, 158–159
Optohydrodynamic cleaning process
laser-assisted, 156, 156f

P

Parenteral drugs, 24–25
Particle cleanliness levels for surfaces, 2
Particle count test, 110f, 111, 113f, 117f
Particle detachment, 57–68
adhesion forces, 58–64
maximum adhesion resistance moment, 61–62
particle adhesion models on rough surfaces, 62–64
external forces, 64–67
hydrodynamic forces, 65–67
removal mechanism, 67–68, 67t
Particle resuspension from surfaces, 55–56
particle detachment, See Particle detachment
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
roughness effect, 78–79
Particle size, 72–74
Particle–surface interaction, 57
Personal hygiene, 107
Personnel gowning, 107–108
Personnel training, 106–107
Pharmaceutical Inspection Convention (PIC), 87
Photoluminescence (PL) imaging, 33
Physical barrier concept, 106
Plant uniform, 94
Potassium, 11–12
Preexponential factor, 13–15
Process related metal contaminants, 30
Product quality review, 93
Product surface, 125
Production area, 99
Production department, 93–95

Q

Quality assurance, 92–93
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 assurance, 92
quality control (QC), 92–93
Quartz, 1–2

R

Recovery test, 117
Regulatory bodies, 86, 88t
Regulatory organizations, 111–112
Relative humidity, 56, 74–75
Resuspension experiments, 68–77
experimental resuspension data, 72–77
particle size, 72–74
relative humidity, 74–75
time dependency, 75–76
wind tunnel and duct flow characteristics, 68–71
Retrograde melting, 19–21
Retrograde solubility, 20f, 21t, 22f, 22t
Rhodium, 15–16
Roughness effect, 78–79

S

Sanitation and personal hygiene, 107
Scanning electron microscopy (SEM), 158–159
Secondary ion mass spectroscopy (SIMS), 31
Semiconductor Equipment and Materials International (SEMI), 2
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
Sodium, 11–12
Solubility of solute impurity, 16–23
Standards, 105
agendas, 110–111
chronic emergency standards, 109–110
conveying the information, 127
figures and flowcharts, 127
sentences versus figures/flowcharts, 127
emergencies, 114
evolution of standards, 123
examples, 114–123
American Society for Testing and Materials (ASTM), 115–118, 116t
China Food and Drug Administration (CFDA), 120–123
ISO and ANSI, 118–120
ideal standards, 106–109
interpreting standards, 124–126
interpretation of cleanroom standards, 124–126
language, 110
need for, 106–114
perfection versus reality, 110
political influences, 111–113
intentionally ambiguous wording, 112–113
regulatory organizations, 111–112
process, 113–114
questions to ask, 127–129
achievability, 129
coping with standards, 129
relevance, 128
sufficiency, 128–129
real standards, 106–109
scope, 126–127
standards committee, 127
Stokes–Einstein–Sutherland formula, 14
Surface photovoltage (SPV) method, 33
Synchrotron-based X-ray fluorescence techniques, 32–33

T

Temperature uniformity test, 118
Thalidomide, 86
Time dependency, 75–76
Titanium, 11–12
Total reflection X-ray fluorescence spectrometry (TXRF), 31
Trace element content of various plastics, 23, 26t
Trace metals, 23

U

Unidirectional airflow pattern test, 102–104, 110f
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

Vaporization of droplets, 156, 163, 165–166
Vapor-phase decomposition droplet collection (VPD-DC), 31
Ventilation, 101
Viable monitoring, 111–115
active air sampling, 113
passive air sampling, 114
surface monitoring, 114–115
contact plate method, 114–115
swabbing method, 115

W

Wet laser cleaning (WLC), 155–156
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
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