SP Industries, Inc

Depyrogenation Tunnels

Features
 SP PennTech is the only manufacturer of continuous processing tunnels in the United States
 In fewer than 30 minutes, an untreated vial goes from vial washer to sterilizing tunnel to cleanroom, entering in a sterilized microorganisms- and pyrogen-free state
 Requires no operator intervention or recontamination
 Typical operating temperature of the tunnel is 320°C
        At this temperature:
           It takes 9.5 seconds to reduce the bacterial endotoxin level by 1-log
           A 4-log reduction will take 38 seconds
          A 6-log reduction in bacterial endotoxin 57 seconds
 Heat is generated by silicon controlled rectifier (SCR) heating elements
 Depending on the format, vials stay inside the sterilizing/depyrogenation chamber for approximately 6-10 minutes
 The recirculated hot air is blown at a speed of approximately 0.7 m/s over the vials and remains within 2°C of its setpoint
 Keeping control over the vials at all times, vials are fed from the vial washer via a sanitary conveyor before gently being pushed into the tunnel by an oscillating pusher
 No format parts are required
 This is essentially a set-it-and-forget-it automatic process
 There are 3 chambers: pre-heating chamber, sterilizing chamber, and cooling chamber
 Chambers of the tunnel are separated by gates and the height is automatically set by the PLC as part of the vial recipe
 HEPA filters are tested for efficiency by the “DOP” test procedure (each chamber of the tunnel has provisions to conduct the DOP test)
 Each chamber is equipped with a pipe below the filters to allow for particle counting