Page 271 - Assurance of Sterility for Sensitive Combination Products and Materials

Index 249

P management framework, 243
Package/container closures to single-use products, 241–242
and device families, 110–111 Parametric analysis, 177–179
functions, packaging systems Patient-related factors, HAIs risk
challenges, 94–95 assessment, 137–138
container types/definitions/dosage antibiotics, 143
form, 88–90 direct person-to-person spread of
medical device vs. pharmaceutical bacteria, 144
packaging, 83–87 indirect person to person spread of
plastic selection-pharmaceutical and microbes, 144
medical device packaging, 91–93 means of transmission, 142–144
stability issues related to, 93–94 source of microorganisms, 141–145
information for, 92t susceptible host, 141–142
integrity and sterility testing limitations, Patient risk concepts
96 industry sectors vs. real-world infection
point estimates and confidence bounds, rates
179–182 bioburden control, in manufacturing
power and sample size considerations environment, 202–203
equivalence testing, 121–122 hospital infection rates vs. medical
overview, 117–119 device, 204f
for significance testing, 121 infection probabilities estimation,
statistical significance and functional 196–201
equivalence OC curve, 189f
power and sample size considerations, patient’s immuno-compromised status,
equivalence testing, 124 202
sample size, process capability in PNSU* and upper confidence bounds,
process validation, 124–128 191f
sterile packaging, history of, 80–82 representative risk graph, 168f
and sterilization analysis, 179 sterilization validation methodology,
validation principles 203
design validation, 102–107 ISO 14971
examples of approaches, 115–124 core concept, 169
forming, 107–109 risk management process, 168t
managing changes and revalidation, packaging and sterilization
111–115 analysis, 179
microbial barrier test methods, 99–100 point estimates and confidence
package integrity and sterility testing bounds, 179–182
limitations, 96 risk acceptability
packaging and device families, alternative treatments, 206
110–111 duration of benefits, 206
and patient safety, 95–96 health-care professionals (HCPs) and
sealing (closure) and assembly process caregivers, 206
validation, 107–109 magnitude of benefits, 206
test methods, 96–102 methods of determination, 205
Pan-industry sterility assurance risk patient factors, 206
framework patient impact, 206
end-to-end sterility assurance, 242–243 probability of patient benefits, 206
in health-care facilities, 241 product availability, 206