Page 267 - Assurance of Sterility for Sensitive Combination Products and Materials

Index

Note: Page numbers followed by f indicate figures, t indicate tables, and b indicate boxes.

A interventions and activities, 51–52
Accelerated aging, 106 isolators/barrier isolators, 59–60
Adhesive systems, 111 ISO 13408 series of standards, 234–235
Agency for Healthcare Research and line of sight (LOS) approach, 44–46
Quality (AHRQ), 138 microbial contamination case study,
Airflow, 153–155 64–66
Airflow/air profile visualization (smoke) personnel monitoring, 55–56
studies, 57 point estimates and confidence bounds,
Alpha value, 103 182–186
Alternative SAL approach practices, 50–51
benefit identification, 218 qualification and validation, 61
bioburden reduction, 217–218 quality risk management and risk-based
device compatibility improvement, critical thinking, 74–76
215–217 requirements, 46–47
documentation of systematic assessment, rules, 75
217 semiannual basis, 66–67
document efforts, 218–219 simulation design, 62–64
exposure time reduction, 217 simulation study design, 66
by ISO 19930, 212 steps, 67
risk identification, 218 sterile claim using, 222
Ampule, 88 sterile combination products, 40
ANOVA, 107 and sterility assurance, 234
Antibiotics, 143 sterility by design, 44
Antimicrobials, 151–152 terminal sterilization, 235–236
Antioxidant, 93–94 traditional sterilization, 222
Arrhenius equation, 81 and usability aspects, 105
Aseptic presentation, 105 user requirement specification (URS), 49
Aseptic processing utilities, 60–61
acceptance criteria, 71–72 worst-case conditions, 68–69
airflow/air profile visualization (smoke) written procedures, 68
studies, 57 Assembly process validation, 107–109
basis of design, 47–49 Association for the Advancement of
clean room design, 56–57 Medical Instrumentation (AAMI),
decision tree for sterilization, 213f 231–232
description, 41–44 ASTM committee, 82
design, 44
documents pertaining to, 234 B
drug product sterility, 40–41 Behavior, HAIs risk assessment
duration, 69–71 isolation precautions, 149–150
environmental monitoring, 54–55 standard precautions, 149–150
filtration and, 229 BI approach, 33
first air principles, 52–53 Bias section, 82
future of, 72–74 Bioabsorbables, 19–21