Snap Shots of Qualification:
Set points: Record the ammeter values and differential pressures.
Differential Pressure:The Tunnel zones are balanced per the manufacturer specifications. Air does not move from dirty to clean.
Air Velocity:Critical Areas should have laminar airflow of 90 fpm ± 20%, or 28 m/min ± 20%
Laminarity Smoke Testing:The entry hot and cooling zones demonstrate laminar air flow.
|Smoke flow direction with the Tunnel Sterilizer
Total Particulate Counts:The oven must meet specifications for total particulates, . less than or equal to 100 for less than 0.5 micron per ft3 or less than or equal to 3,500 for less than 0.5 micron per m3 and 0 for 5 micron per m3
Thermocouple Calibration: 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.Eighty-five percent of thermocouples used must be operational upon 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 range among thermocouples for Tunnels at 250*C and greater, 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 temperatureCalculation of tunnel speed and cycle timing is a important issue during validation of Sterilization and Depyrogenation tunnel. We can solve with a easy two steps mention below.
Temperature Mapping, Specific Loads:To determine cold spots.Monitor Tunnel differential pressure during the depyrogenation period.
Endotoxin Studies, done in triplicate: 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 Depyrogenation, PDA Technical Report Number 3.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 mean of the distribution thermocouples.
Example for Conveyor speed calculations,
# Vial Dimension 50 mm
# Speed of conveyor 135 mm/min
# Length of the tunnel 457 mm
# Width of the tunnel 1200mm
No’s of vial lying vertically = 1200 mm/ 50 mm = 24 vials
No of vial lying horizontally = 457 mm / 50 mm = 09 vials
Total vial capacity in the tunnel sterilization zone = 24x09 = 216 vial
If 50 mm moved 09 vial will released from hot zone. In case of machine speed 135mm/min means
(9x135)/50 = 24 vials will come from hot zone/per min
Time spend by the each vials id 135 mm/50 mm = 2.7 min