Dear Tzafrir,
Normal practice is to perform loaded conveyor heat distribution and
penetration.
The testing conditions are same in both cases.
The difference between the two is only positioning of the tip of the
thermocouple.
During heat distribution study the tip of the thermocouple will be
exposed to the air (top of the container) to map the temperature of the
air.
During heat penetration study the tip of the thermocouple will be
touching the inside bottom corner of the glass to map the glass
temperature. (The worst case location inside the container shall be
established by container mapping, if it is bigger container like 500ml
etc.)
Purpose of this study is only to compare the temperature of the air and
the glass (delta T).
Regards,
Rajesh Pai
On Thu, Jan 7, 2010 at 9:28 PM, Tzafrir
<tzafriris@gmail.com>
wrote:
- 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
- --------------------------------------------
Tzafrir
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