Page 60 - Assurance of Sterility for Sensitive Combination Products and Materials

studies, environmental and
Autoclave IOQ, temperature
gowning and personnel
mapping, BI studies, air
personnel monitoring,
Air profile studies, risk
assessment, training,
disinfectant efficacy
qualification aseptic
removal studies
testing
room sanitization, airflow,
conditions, properly sized
workflow, people flow …
principles, smoke studies
monitoring/recording,
Clean room design, clean
filters, training, first air
of components, clean
Autoclave design, cycle
patterns, automated
receipt and storage
established loading
ingredient storage
component and
Control strategies
random loading patterns,
conditions, incorrect or
Poor aseptic and gowning
Inadequate temperature
incorrect components
excessive bioburden,
air in system, steam
and exposure time,
Process variables
technique
Example of line of sight process evaluation. 48 Qualification/validation Assurance of sterility for sensitive combination products and materials process simulations Design qualification, vendor Container/closure design, Leakage Container closure audit, incoming inspection, sealing process control, integrity leak detecti
Process steps
processing
Sterilization
Aseptic
Table 4.1 CQA Safety—sterility Safety—sterility Safety—sterility