Page 269 - Assurance of Sterility for Sensitive Combination Products and Materials

Index 247

Drug-eluting beads (DEBs), 8–21 Functional equivalence, 122–124
sterilization, 19–21 Functions, packaging systems
Drug-eluting stents (DES) sterilization, challenges, 94–95
16–19 container types/definitions/dosage form,
Drug product sterility, 40–41 88–90
Dry heat sterilization, 210 medical device vs. pharmaceutical
history, 26–27 packaging, 83–87
Dye penetration, 98–99 plastic selection-pharmaceutical and
medical device packaging, 91–93
E stability issues related to, 93–94
Electron beam and x-ray radiation
sterilization, 240 G
EMA documents, 222 Gas delivery, 32
End-to-end sterility assurance, 242–243 GHTF, 88–90
Engineering solutions, HCF suite/room Gloves, 154
design Glucose control, postoperative, 153–154
airflow and ventilation, 153–155 Good manufacturing practice (GMP), 82
protection and barriers, 155–161 Gowns, 155
traffic patterns, 155–161
Environmental monitoring, 54–55 H
Equipment qualification, 28 Health-care-associated infections (HAIs),
Ethylene oxide (EO) sterilization, 210, 240 95–96
history, 25 causes, 135–136, 138
Protection and barriers, HCF, 160 challenges, 240
European Standards (EN), 222, 232–233 classification, 145–146
EN 556-1, 233 prevention, 140, 151
EN 556-2, 235 risk assessment
terminal sterilization, 232–233 behavior, 149–161
EU submission process burden/impact of, 138–139
CE-marking, for medical device, engineering solutions, 152
227–228 identification, 138
market authorization, as medicinal patient-related factors, 137–149
product, 226–227 procedural interventions, 151–152
regulatory classification, 225–226 procedural-related characteristics,
Evaluation of medicinal products (EMA) 144–145
guidance, 222 risk factors, 137
Extractables and leachables, 104 transmission-based isolation
precautions, 150–151
F WHO “Safe Surgery Saves Lives”
Facial protection, 153–154 initiative, 148
First air principles, 52–53 sterilization cycle time, 155
Food and Drug Administration (FDA) surgical site infections (SSIs), 136
guidance, 31 types, 135–136, 146
feedback, 223–225 Health-care personnel attire, 151
on labeling devices as sterile, 228–231 Health-care products classification, 1
methods of sterilization, 229–230 Health-care professionals (HCPs) and
510(k) submission, 230–231 caregivers, 206
Forming, 107–109 Heat exposure, 42–43