Sterilising Tunnels

These laminar airflow tunnels are designed to continuously and efficiently sterilise and depyrogenate pharmaceutical glass containers, in a Class 100 environment at 320ºC. At this temperature, it takes only 9.5 seconds to reduce the bacterial endotoxin level by 1-log. A 4-log reduction will take 38 seconds, whilst a 6-log reduction will take 57 seconds.

Heat is generated by silicon controlled rectifier elements. Depending on the format vials stay inside the sterilising chamber for approximately 6-10 minutes. The recirculated hot air is blown at a speed of approximately 0.7m/s over the vials, and remains within 2°C of its setpoint. SP i-Dositecno sterilising tunnels are fully compatible with SP i-Dositecno vial handling solutions and trayloaders and can be integrated into other existing or new installations.

Benefits

Highly effective sterilisation: Guaranteed thermic cycle regardless of pressure fluctuations

Efficient automatic processing: Fully automatic, continuous aseptic processing offers increased efficiency for batch processing

All manufacturing requirements: Modules available for small and large batch sizes

Features

  • In fewer than 30 minutes, an untreated vial goes from vial washer to sterilising tunnel to cleanroom, entering in a sterilized microorganism- 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, sterilising chamber, 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)
  • Each chamber is equipped with a pipe below the filters to allow for particle counting
  • Dimensions
    Varies depending on the model
  • Purpose
    Fully automatic sterilization/depyrogenation tunnels for vials, syringes and ampules
  • Vial Range
    2-100ml
  • Output
    Varies depending on the model
  • Changeover
    Varies depending on the model