Steriline USA & AWS Bio-Pharma Technologies, LLC

Steriline offers a wide range of depyrogenation tunnels appropriate for any production requirement. The models ST0, ST1, ST2, and ST3 feature a variety of production capabilities for processing ampoules, small vials, and syringes. This series is compact in design to fit even the tightest production spaces. In addition to normal production facilities, these models are suitable for use by research and development laboratories.

Steriline's mid-size depyrogenation tunnels, models ST4 through ST9, were specifically developed as a response to demand from pharmaceutical manufacturers for handling a wide range of container types and sizes. These extremely versatile, reliable, high performance machines can handle from 1 to 1000 ml glassware in the same tunnel.

Steriline's large series depyrogenation tunnels, models ST12 through ST15 and ST18 through ST20 have been introduced to accommodate the ever increasing speeds demanded by today's modern production lines. These models are suitable for higher speed traditional glass processing. The Steriline feature that is unique to these models is the utilization of two cooling chambers instead of one. Two cooling chambers with two different temperature set points reduces thermal shock normally encountered when cooling glassware too rapidly.

    Among the many advantages of a Steriline depyrogenation tunnel, is the unique "closed tunnel" system. The system recirculates air to provide the cascading air balance required between the aseptic and non-aseptic areas; only a small exhaust is required for full balance and control. Steriline's system of automatic air balance senses air pressure changes between the aseptic and non-aseptic space and compensates automatically. Thus, the desired pressure differential between the aseptic space and the cooling chamber, and between the cooling chamber and inlet chamber of the depyrogenation tunnel is properly maintained. This system insures a very controlled backflow of air coming from the aseptic space. The automatic air balance system can compensate for pressure changes of up to 2Pa (0,02 millibar) per second, with a maximum of 100Pa (1 millibar) differential pressure between the aseptic space and the cooling chamber.
    Steriline heating elements are made of AISI 304S/S, and are SCR controlled. They're installed before the hot zone fan, which insures air temperature uniformity. The heating elements are installed on the heating chamber door for easy maintenance access and the control wiring is protected in a non-heated area.
    Steriline's special attention to air distribution permits the temperature of the heaters to be as low as possible, extending the life of the heaters and maintaining the   sterilization   temperaturewithin 1°C ( 1,8F ) of set point. The conveyor belt is made of 304 S/S (optional 316L S/S) mesh with solid side rails, which eliminates friction between the vials and the tunnel chamber. The belt is returned through a closed duct connecting the cooling and inlet chambers, thereby avoiding contact with the hot chamber.
    The depyrogenation tunnel's Human Machine Interface (HMI) is used by the operator to select a preprogrammed vial recipe. The HMI interfaces with the PLC which controls the critical process parameters including gate height adjustment, conveyor belt speed, depyrogenation temperature, air speed, etc.
All HEPA filters used in Steriline depyrogenation tunnels have a minimum efficiency of 99.97% at 0.3µm (higher efficiency filters are available upon request).

Steriline now offers an optional sterilizable cooling chamber on all its Depyrogenation Tunnels. The cooling chamber sterilization cycle is executed when the tunnel is not in production. The cooling chamber is sterilized by means of HEPA filtered hot air at a temperature of approximately 200°C. The cycle time is defined during the pre-testing phase at Steriline, and calculated in order to ensure that the coldest point inside the chamber is sterilized when the cycle has been completed.

The minimum surface temperature anywhere in the cooling chamber on any material should be above 170°C . The coldest point shall stay at a temperature of 170°C as long as necessary to achieve bacterial reduction of 6 log.

Heating elements are installed in the cooling chamber for sterilizing the cooling chamber by means of dry heat;

The cooling chamber is equipped with an insulation to provide protection at temperatures up to 230°C;

An airtight insulated door at the tunnel exit (equipped with high temperature inflatable gasket), protects the isolator during the cooling chamber sterilization and enables the isolator to be sterilized without any leak of VHP into the tunnel;

When using an isolator it is difficult for an operator to reach into the tunnel exit to manually remove the remaining vials at the end of the batch. Therefore the tunnel is equipped with an automatic discharge bar to fully discharge the vials at the end of the process.

The sequencing of the cooling chamber sterilization cycle is automatically carried out by the tunnel's PLC once the operator starts the cycle:

The airtight door closes and the insulated gaskets inflate;
The cooling water circuit drains;
All tunnel heaters start;
The cooling chamber temperature raises up to the predefined set point, and is maintained for the predefined sterilization time;
When the elapsed time is equal to the set time, the heaters switch off and the temperature decreases slowly;
At 90°C the cooling water circuit is refilled;
When the cooling chamber has completed the cool down cycle, the tunnel is once again ready for production.

Last modified: 10/12/06