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Tunnel

The document summarizes the installation, operational, and performance qualification criteria for a depyrogenation tunnel. The tunnel must be made of 304 stainless steel and have HEPA filters. During operational qualification, the tunnel will be tested to ensure proper air flow velocities, laminar flow, particulate counts and temperature mapping within specifications. Performance qualification involves endotoxin studies using different vial sizes to demonstrate at least a 3-log reduction in endotoxin under specified temperature conditions.

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Mahesh Mahi
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531 views

Tunnel

The document summarizes the installation, operational, and performance qualification criteria for a depyrogenation tunnel. The tunnel must be made of 304 stainless steel and have HEPA filters. During operational qualification, the tunnel will be tested to ensure proper air flow velocities, laminar flow, particulate counts and temperature mapping within specifications. Performance qualification involves endotoxin studies using different vial sizes to demonstrate at least a 3-log reduction in endotoxin under specified temperature conditions.

Uploaded by

Mahesh Mahi
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Depyrogenation Tunnel

Installation Qualification

In addition to the common requirements outlined in the "General" section, the tunnel and
conveyor belt must be at least 304 stainless steel. The unit is supplied with heat resistant HEPA
filters 

Operational Qualification

In addition to the common requirements outlined in the "General" section, the tunnel
differential pressures prevent air travel from the dirty to clean areas.

Critical Areas should have laminar airflow of 90 fpm ± 20%, or 28 m/min ± 20% The tunnel
must meet specifications for total particulates for a Class 100 area.
Rate of speed, minimum, maximum and nominal, will be measured and verified.
Physical handling of containers will be monitored. No containers should be damaged, none hung
up, or dislodged.

The tunnel will be temperature mapped to demonstrate consistency. During the temperature
mapping period, the temperature readings for the temperature recording chart and the average
chamber temperature for tunnels at 250*C and greater are consistently ± 15.0*C of each other
throughout the study. The temperature range among thermocouples for ovens at 250*C and
greater, for each five minute interval, is ± 15.0*C of the average temperature throughout the
study. Average is ± 15.0*C of the setpoint.

Note: Infrared tunnels, which heat components, not the air, cannot be mapped in the absence
of bottles. The mapping is therefore performed in the PQ. 

OQ Acceptance Criteria

Setpoints Record the ammeter values and differential pressures.


Differential The Tunnel zones are balanced per the manufacturer specifications. Air does
Pressure not move from dirty to clean.
Critical Areas should have laminar airflow of 90 fpm ± 20%, or 28 m/min ±
Air Velocity
20%
Laminarity
The entry hot and cooling zones demonstrate laminar air flow.
Smoke Testing
The oven must meet specifications for total particulates, . less than or equal
Total Particulate
to 100 for less than 0.5 micron per ft3 or less than or equal to 3,500 for less
Counts
than 0.5 micron per m3 and 0 for 5 micron per m3
All thermocouples will calibrate within ± 0.5*C of the reference temperatures
before protocol execution and verify within ± 0.5*C of the high reference
temperature after protocol execution.

Thermocouple Eighty-five percent of thermocouples used must be operational upon


Calibration completion of the study.

All critical thermocouples (i.e. thermocouples with specific acceptance criteria,


such as cold spots or adjacent to a controller)must be operational upon
completion of the study.
During the mapping period, the temperature readings for the temperature
recording chart and the average chamber temperature for Tunnels at 250*C
and greater are consistently ± 15.0*C of each other throughout the study: 

Temperature Temperature range among thermocouples for Tunnels at 250*C and greater,
Mapping for each five minute interval, is ± 15.0*C of the average temperature
throughout the study. 

The average temperature for Tunnels at 250*C and greater at each interval is
± 15.0*C of setpoint temperature

Performance Qualification

During the PQ, each vial size that will be used during production will be qualified. The study
method employed will be that described in Validation of Dry Heat Processes Used For
Sterilization and Depyrogenation, Technical Report No. 3, Parenteral Drug Association, 1981. At
least one heat penetration study using thermocouples will be performed on each vial size.
Temperature uniformity and delivery of heat will be documented. At least three endotoxin
studies will be performed on each bottle size. Heat delivery and depyrogenation will be
monitored by thermocouples and endotoxin reduction respectively. A minimum of a three log
reduction in endotoxin must be demonstrated. 

PQ Acceptance Criteria

Temperature To determine cold spots.


Mapping, Specific
Loads Monitor Tunnel differential pressure during the depyrogenation period.
Inoculate glassware or vials with a minimum of 5,000 EU of E. coli
lipopolysaccharide.

All inoculated glassware placed must demonstrate, at minimum, a


three-log reduction in endotoxin.

Positive controls must demonstrate a minimum recoverable 1,000 EU,


per Validation of Dry Heat Processes Used for Sterilization and
Endotoxin Studies,
Depyrogenation, PDA Technical Report Number 3.
done in triplicate
Negative controls (pyrogen free water) must not exhibit a level of
endotoxin above the minimum sensitivity of the reagent used.

Minimum cumulative FH location will be determined for informational


purposes only.

Distribution thermocouples are within a range of ± 15.0* C from the 

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