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Published by maheshatqa
depyrogenation tunnel validation
depyrogenation tunnel validation

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Published by: maheshatqa on Oct 10, 2010
Copyright:Attribution Non-commercial


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Depyrogenation Tunnel
Installation Qualification
 In addition to the common requirements outlined in the "General" section, the tunnel andconveyor belt must be at least 304 stainless steel. The unit is supplied with heat resistant HEPAfilters
Operational Qualification
 In addition to the common requirements outlined in the "General" section, the tunneldifferential 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 tunnelmust 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 hungup, or dislodged.The tunnel will be temperature mapped to demonstrate consistency. During the temperaturemapping period, the temperature readings for the temperature recording chart and the averagechamber temperature for tunnels at 250*C and greater are consistently ± 15.0*C of each otherthroughout the study. The temperature range among thermocouples for ovens at 250*C andgreater, for each five minute interval, is ± 15.0*C of the average temperature throughout thestudy. Average is ± 15.0*C of the setpoint.Note: Infrared tunnels, which heat components, not the air, cannot be mapped in the absenceof bottles. The mapping is therefore performed in the PQ.
OQ Acceptance Criteria
 Setpoints Record the ammeter values and differential pressures.DifferentialPressureThe Tunnel zones are balanced per the manufacturer specifications. Air doesnot move from dirty to clean.Air VelocityCritical Areas should have laminar airflow of 90 fpm ± 20%, or 28 m/min ±20%LaminaritySmoke TestingThe entry hot and cooling zones demonstrate laminar air flow.Total ParticulateCountsThe oven must meet specifications for total particulates, . less than or equalto 100 for less than 0.5 micron per ft3 or less than or equal to 3,500 for lessthan 0.5 micron per m3 and 0 for 5 micron per m3ThermocoupleCalibrationAll thermocouples will calibrate within ± 0.5*C of the reference temperaturesbefore protocol execution and verify within ± 0.5*C of the high referencetemperature after protocol execution.Eighty-five percent of thermocouples used must be operational uponcompletion of the study.All critical thermocouples (i.e. thermocouples with specific acceptance

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