Product/Service

Pharmaceutical Sterilization Tunnel

Source: SP Scientific

Pharmaceutical Sterilization Tunnel

Fully automatic sterilization/depyrogenation tunnels for vials, syringes and ampoules for pharmaceutical manufacturing. SP PennTech is the only manufacturer of continuous processing tunnels in the United States for pharmaceutical manufacturing

Dimensions
Varies depending on model

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 for pharmaceutical manufacturing
  • 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