Page 268 - Assurance of Sterility for Sensitive Combination Products and Materials

246 Index

Bioburden-based approach protein stabilization, 16b
and BI-based approach, 31–32 regenerative medical devices with
in manufacturing environment, 202–203 biologics, 16–19
point estimates and confidence bounds, regulatory evolution of, 1
179 spinal fusion system sterilization, 18b
terminal sterilization, 30–31 sterile, 40
Biological compatibility, 103 sterilization
and toxicological attributes, 103–104 “first do no harm” code, 5–7
Bleach products, 139 methods, 9f
Blister, 126 mode of, 7–8
Bottles, 111 terminal, 7–8
Confidence bounds, 175
C Confidence interval
Cartridge, 88 approach, 111
Catheter-associated urinary tract infections example, 171–173
(CAUTIs), 140 Conformity demonstration, 228
CDC SSI Guideline 1999, 148–149 Container types/definitions/dosage form,
CEN, 80 88–90
Center for Biologics Evaluation and Contamination, 88
Research (CBER), 223 rate, 3
Center for Devices and Radiological C pk , 110–111
Health (CDRH), 223 Critical defect, 97–98
Central line-associated blood stream Critical leak rate, 97–98
infections (CLABSIs), 140
Chemistry, Manufacturing, and Controls D
(CMC) section, 226 Decision tree for sterilization
Cleaning aqueous products, 211, 213f
protection and barriers, HCF, 155 dry powder products, 211–212, 214f
validation, HCF, 156 nonaqueous liquid, 211–212, 214f
Clean room design, 56–57 semisolid products, 211–212, 214f
Combination products Design and manufacturing information, 228
ascendance of, 20f Design control, 94–95
and associated regulatory aspects, 3–4 Destructive test, 80
bioabsorbables, 19–21 Deterministic event, 97–98
challenges for, 3 Device-associated infections, 145–146
definition, 5, 6f industrial single-use devices, 146
drug delivery systems reusable devices, 146–149
novel, 13 surgical site infections, 147–148
traditional systems, 13 Device change management, 94–95
varithena (polidocanol injectable Direct person-to-person spread of bacteria,
microfoam) 1%, 14b 144
drug-enhanced devices Disinfection, 156
DEB sterilization, 19–21 Drapes, 155
DES sterilization, 16–19 Drug delivery systems
electrical components, 20–21 novel, 13
electronics, 19–21 traditional systems, 13
health-care risks to patients, 2 varithena (polidocanol injectable
opportunities, 239 microfoam) 1%, 14b