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TSL
Depyrogenation tunnel

TSL – depyrogenation tunnel guarantees the continuous sterilization and depyrogenation of glass containers such as vials, type R or type H, by means of filtered high temperature air (max 350°C) in laminar flow conditions. The air laps vertically the containers, with uniform increase of the heat, achieving a shorter time sterilization process.

TSL - Depyrogenation tunnel

TSL at a glance

Technical Characteristics

  • Designed and manufactured according to current GMP standards and FDA rules
  • Suitable for all glass containers
  • Containers contact parts made of AISI 316L stainless steel and strong AISI 304 frame
  • Automatic adjustable IN/OUT gates
  • HEPA filters with DPT control and adjustable speed fans with air speed control
  • Automatic balancing of internal pressures
  • Thermal insulation and heat recovery, heating modulation
  • Temperature set-point up to 350°C and bacterial reduction up to log 6
  • Low consumption
  • Small dimensions (maximum height less than 2 meters)
  • Ease of maintenance and accessibility
  • Low noise (below 75 dBA)
  • CFR21 Part 11 compliant PLC/HMI control and process recording
  • Production up to 350 kg/h
  • Available options: air/water cooling batteries, cooling room sterilization, automatic unloading

The Tunnel consists of three zones:

Infeed zone

A vertical laminar flow protects the tunnel entrance from the external contamination, and avoids the coming out of the hot air. The air is prefiltered, HEPA filtered and then flows over the vials in laminar condition, at a speed adjusted around to 0,4 – 0,5 m/s, with air speed measurement.

Depyrogenation zone

The chamber is made by stainless steel shell, externally protected by approved insulation materials (ceramic).

The tunnel is provided of a variable number of HEPA filters for high temperature (max 350°C). In the depyrogenation chamber the air is fully ricirculated. For each filter, a fan placed in the bottom of the tunnel, sucks the air out from under the conveyor belt (in the coolest point of the recirculation loop) and blows the air towards the heaters, placed along the supply duct, directly on the equalization system, through the filters and, finally, on the vials. In this way there is a pressure increase in the air flow just for the temperature increase, with less efforts in the fan functioning and a longer device lifetime.

The air speed is adjusted and controlled with optimal unidirectional flow conditions.

The max temperature set-point is 350°C. In order to save energy and to not overheat the glass, each type of vial is processed with the suitable time/temperature setting to achieve the desired depyrogenation degree.

Heaters

The heaters are installed on the side of the sterilizing chamber. The air speed through the heater is designed in order to have the temperature of the heaters surface as low as possible allowing them a longer life.

Filters

The HEPA filters have an efficiency of ~99,997% (H14) on 0,3 μm particles. The HEPA filters of the depyrogenation chambers have an efficiency of ~99,99% on 0,3 μm particles (H13).

Closing system

At the entrance and the exit of the tunnel, two motorised doors will lower down to close the machine ends, when the closure is complete, the gaskets are pressurised to guarantee the perfect tightness and to perform the cooling chamber starilisation cycle (optional).

Conveyor belt

The conveyor belt is made of AISI 304 stainless steel (option AISI 316) connected with vertical wings at the sides to avoid friction between vials and the walls of the tunnel.

Cooling zone

In the cooling module the air is sucked from the room.
The air is first pre filtered, HEPA filtered and the air speed is adjusted and controlled with optimal unidirectional flow conditions.

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