Page 274 - Assurance of Sterility for Sensitive Combination Products and Materials

252 Index

Surgical setting attire, 151 U
Surgical site infections (SSIs) United States (US) standards, 222
deep incisional, 146 User requirement specification (URS), 49
device-associated infections, 147–148 USP, 88–90
organ/space, 146–147 Utilities, 60–61
superficial incisional, 149
type of infection, 149 V
Susceptible host, 141–142 Validation
overview, 33–34
T principles
Terminal sterilization design validation, 103–104
AAMI ST67, 231–232 examples of approaches, 115–124
aseptic processing and assurance of forming, 107–109
sterility, 234 managing changes and revalidation,
BI approach, 33 111–115
bioburden and BI-based approach, 31–32 microbial barrier test methods, 99–100
bioburden-based approach, 30–31 package integrity and sterility testing
dry and moist heat limitations, 96
history, 26–27 packaging and device families,
EN 556-2, 235 110–111
EO sterilization and patient safety, 95–96
history, 25 sealing (closure) and assembly process
European standards, 232–233 validation, 107–109
history, 23–27 test methods, 96–102
ISO guidance, 233–234 qualification and, 61
ISO 13408 series, 234–235 sterile
medicinal products evaluation, 235–236 approaches of, 28–33
point estimates and confidence bounds, equipment qualification, 28
186–194 product qualification, 28
protection and barriers, HCF, 159 sterilization methods, 210
radiation sterilization Varithena (polidocanol injectable
history, 24–25 microfoam) 1%, 14b
sterile validation Ventilation, 153–155
approaches of, 28–33 Vial, 88
equipment qualification, 28 Visual inspection, 99–100
product qualification, 28
validation overview, 33–34 W
Traffic patterns, 155–161 WHO “Safe Surgery Saves Lives” initiative,
Transmission, 142–144 148
Transmission-based isolation precautions Worst-case conditions, 68–69
health-care personnel attire, 151 Wounds
nonsurgical setting attire, 151–152 classes of, 146
surgical hand scrub, 150–151 contamination, 146
surgical setting attire, 151
T-test, 108 X
Tyvek, 80–81 XStraw, Dose Sipping Technologies, 126