DEPYROGENATION TUNNELS

Dimensions
Varies depending on model

Purpose
Fully automatic sterilization/depyrogenation tunnels for vials, syringes and ampules

Vial Range
2-100ml

Output
Varies depending on model

Changeover
Varies depending on model

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