Application of Ampoule and Vial Sterilizing Depyrogenating Tunnel Oven
Application of Ampoule and Vial Sterilizing Depyrogenating Tunnel Oven
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Application of Ampoule and Vial Sterilizing Depyrogenating Tunnel Oven
September 14, 2022
In recent years, the development of China’s pharmaceutical industry has changed with each passing day, and the industrial system has been constantly upgraded. When choosing pharmaceutical equipment, pharmaceutical enterprises will not only consider the performance of the equipment and the relevant experience of the manufacturer, but also continue to improve their equipment expertise. Whether pharmaceutical equipment can finally pass the test of relevant regulatory authorities or the market is often up to the combination of equipment performance and production technology. In view of the sterilizing which has attracted much attention in the market recently, this paper analyzes its application and type selection.

The main objectives of the new generation of tunnel development are:

  • New manufacturing platform

  • Modular design

  • Wider and more flexible application range

  • Sustainable component standardization

  • The leader of new technology

I. Working principle of sterilization and depyrogenation of the tunnel

The container is heated by dry hot air to realize rapid sterilization and depyrogenation.

II. Recommendations for the main application of sterilizing and depyrogenating tunnel

1.Choose a tunnel with appropriate differential pressure type

(1) Requirements of guidelines / regulations on tunnel differential pressure


The tunnel is a process equipment, which is a sterilizing and depyrogenating device placed in the bottle washing room. It is not applicable to the requirements of ISO14644-4 on adjacent clean rooms or adjacent clean areas.

(2) Recommendations for the use of tunnels with different differential pressure types

Tunnels designed with standard low differential pressure (+3pa) are widely used in the market at present because of their low energy consumption and easier control of differential pressure regulation. The pressure difference used in the filling room and bottle washing room must be below 25Pa.

Example of low differential pressure distribution diagram


Technical characteristics and requirements

  • Quickly respond to room differential pressure changes
  • Under the production mode, the pressure difference between the cooling section and the room is maintained at 2-4pa
  • Room differential pressure fluctuation range±5pa
  • The variation of room differential pressure shall not be greater than 11pa/ min
  • Adjust the differential pressure to normal within a few seconds
Tunnels designed with high differential pressure (+10pa) are more vulnerable to the fluctuation of differential pressure in bottle washing and filling rooms because of their high set value of differential pressure and high energy consumption. It is suitable for room pressure difference within 30Pa
Example of high differential pressure distribution diagram


Technical characteristics and requirements

  • Independent differential pressure control can be carried out in all functional areas in the tunnel
  • Differential pressure setting range 0-15pa
Meanwhile, the clean room with pressure difference above 30Pa and the tunnel with double gradient pressure difference control are suitable for different types of clean rooms, different types of filling machines and different types of sterile products.
Example of high differential pressure double gradient control tunnel


The type selection of tunnel differential pressure control, clean room layout/differential pressure distribution, type of filling equipment(such as RABS or isolator) and type of sterile products(such as high activity, toxic, non-toxic) are related to many factors. The detailed technical parameters need to be comprehensively evaluated by various factors, so as to select the appropriate tunnel with differential pressure control type.


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