Empty chamber run in Depyrogenation Tunnel
Hi everyone
I have few questions about empty chamber run in Depyrogenation Tunnel.
1) Since the airflow profile in an empty chamber is significantly
different than the airflow profile in a loaded chamber (for example,
much higher flow of colder air coming from the filling room because
of the higher pressure), what is the purpose of performing such test?
2) How do you recommend performing an empty chamber validation run in
a Sterilization and depyrogenation Tunnel?
Should we run few rows of vials with thermocouples in an empty
chamber with open doors like a regular run (first row, a row in the
middle of the run and last row) or just check the sterilization
chamber for temperature uniformity with closed doors.
3) What are the acceptance criteria for temperature uniformity?
Should the temperature uniformity be within each row for the whole
process (include heating and cooling) or only for the highest
temperatures (when the temperature stabilized before the cooling phase starts)?
Please advise
Tzafrir
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Tzafrir
tzafriris@gmail.com
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