Biomedical Engineering Reference
In-Depth Information
• Product contact surfaces and utensils must be cleaned and sterilized using
validated procedures.
• Equipment should be selected for reliability of operation, and ease of adjust-
ment.
• Equipment should be tolerant of container and closure variability to the
maximum extent possible.
• Equipment should be designed to minimize interventions in the critical envi-
ronment.
• Equipment should be designed so that operators are ergonomically situated
to minimize stress, discomfort, extended reach, etc.
9.4.4 Containers/Closures
Containers and their closures are intended to maintain the product's quality
attributes.
• Container/closure integrity must be demonstrated to be integral throughout
the product's intended shelf life.
• Containers, closure, and other final container items should be prepared and
sterilized using validated methods to assure their acceptability in the primary
container assembly process.
• Containers, closure, and other items should be selected for ease of handling
in the assembly process.
• These items should be maintained under conditions that best preserve their
sterility and cleanliness until just before use.
9.4.5 Product
The product represents the reason for the entire aseptic process and while its
chemical, physical, and microbiological characteristics are unaltered in the con-
text of the aseptic operation; some important concerns should be addressed.
• The product should be sterilized using a validated process, and delivered to
the aseptic processing environment in a manner that protects its sterility.
• Any connections necessary to deliver sterilized products should be made in
the critical zone of the aseptic processing area.
9.4.6 Procedures
The sequence of activities that comprise the overall aseptic process must be
considered with care to assure their acceptability.
• Processes should be defined to eliminate/optimize/minimize interventions
throughout the process.
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