Packing Systems for Medical Applications
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"According to the current state of knowledge, self-sealing packing
materials are not able to achieve permanent impermeability. Similar, the
reproducibility of this packing process cannot be insured"
ANSI/AAMI/ISO 11607-2:2006
Packing for terminally sterilized medical devices
Part2: Validation requirements for forming, sealing and assembly processes
"One of the most
critical characteristics of a sterile barrier system and packing system for
sterile medical devices is the assurance of sterility maintenance. The
development and validation of packing process are crucial to ensure that
sterile barrier system integrity is attained and will remain so until opened
by the users of sterile medical devices"
"There should be a
documented process validation program demonstrating the efficacy and
reproducibility of all sterilization and packing processes."
HAWO heat sealer comply with
ANSI/AAMI/ISO 11607-2 guidelines
"Essential process variables shall be monitored and recorded"
"The process shall be under control and capable of consistently
producing products according to predetermined requirements"
"Essential processing parameter that are evaluated may include, but
are not limited to:
- Temperature
- Pressure, including rate of change
- Dwell time (line speed)
