8.1.2. Acceptance
criteria:
· Air flow
velocity across the HEPA filter should meet the design specification.
8.2. Verification
of Differential pressures across zones:
8.2.1. Procedure
:
· Monitor
& record the pressure differential values from the calibrated magna helic
gauge across zones.
· Perform
the differential pressure test as per SOP # FU4-QA-GEN-040 and record the
observations for the various zones using manometer.
· While
measuring DP between zone to zone and zone to room, place manometer positive
end in high pressure zone and negative in low pressure zone.
· Record
the observations in annexure-I
8.3. Verification
of conveyor speed :
8.3.1. Procedure:
· Perform
the conveyor speed verification for all the set speeds.
· During
qualification verification of conveyor speed shall be done as per SOP #
FU4-QA-GEN-040.
· Operate
the tunnel as per operational procedure.
· Record
the observations in annexure-I.
8.3.2. Acceptance criteria:
· Conveyor
speed should be within ± 5% of set speed
8.4. Empty
tunnel heat distribution study with belt static condition
8.4.1. Procedure:
· Place
the calibrated thermocouples in the tunnel hot zone as mentioned below diagram
and perform the heat distribution study.
· Set
the proposed process parameters and operate the tunnel as per operating
procedure.
· After
achieving the set temperature in the tunnel start the stop watch and run the
cycle for 20 minutes. After 20 minutes dwell period, stop the tunnel heaters
& stop watch and record the observations.
· Record
the observations in annexure-I.
Probe location diagram:
13.1.1 Acceptance
criteria:
Ø During Depyrogenation
hold time the temperature should be ≥300°.
8.5. Heat
Penetration Study
8.5.1. Procedure
· Heat
penetration study with applicable containers shall be performed.
· The
tunnel when operated with fully loaded containers on the conveyor is capable of
producing the temperature profiles in side the container distributed across the
conveyor belt as per the temperature set points set in the PLC of the
equipment.
· Operate
the tunnel as per operating procedure and perform the heat penetration study as
per SOP # FU4-QA-GEN-040.
· Endotoxin
challenge containers shall not be placed during development study.
· The
placement of temperature sensors in empty container are depicted in the below
diagram.
· Record
the observations in annexure-I.
Note: The tunnel conveyor should not stop when SS zigs are
in depyrogenation zone
8.5.2. Acceptance
criteria:
· Each
temperature sensor of the row should be not less than 300°C for minimum of 3
minutes (Considered as residence time) during Depyrogenation period of each
run.
· The
temperature variation across all sensors in any row shall not be more than 20°C
at any stage in passage of load during calculated residence time.
9. ANNEXURES:
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Datasheet |
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Datasheet to record the successful trial completed
containers |
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