Sterilization and Depyrogenation Tunnel

Sterilization and Depyrogenation Tunnel or pharma sterilizing tunnel uses for online sterilization and depyrogenation of washed glass ampoules & vials. In the tunnel, glass ampoules & vials are transported through a stainless-steel wire conveyor entry from automatic washing machines (non-sterile) to the outlet filing line (sterile area).

Depyrogenation tunnels designed to sterilize and dehydrogenate glass containers with a continuous process maintaining an ISO 5 environment along with whole length and the width of the conveyor belt complying ISO 14644-1 requirements.

Designed to allow higher outputs in a more compact body and with better control of the process parameters.

Adinath tunnels are designed to ensure a reduction in pyrogens by 1000:1 (3 log) or up to 1,000,000:1 (6 log) in accordance with international pharmacopeia and using the following formula.

The D of 4.99 min and a Z of 46.4°C are defined respectively as the required to reduce an endotoxin count by one logarithm T ref of 250°C. Therefore, to achieve 3 log endotoxin reduction, glass containers must be subjected to 15 minutes heat penetration at 250°C or for log reduction in 30 minutes.

The design and controls of the tunnel that parameters set and validated, the reproducibility and reliability of the cycle is maintained.

Exclusive Features of Hot Laminar Sterilizing Tunnel

• Compact GMP Model.
• Each independent filter plenum is provided with filter integrity sample ports.
• The equipment’s conveyor belt is monitored, and alarm status is activated if it operates outside the belt speed set points.
• Provision for ports to allow introduction of validation thermocouples in each zone.
• The tunnel is provided with fully integrated ampoule / vial flow control logic to allow automatic stops and restarts of the equipment.
• All filter modules have differential pressure gauges to monitor pressure.
• Pressure switches with high and low alarms
• When the tunnel is not in use it can be operated in night-mode to save energy while preventing contamination.

Working Principle of Aseptic Filling Machine

Adinath tunnels have identical design concept but with different output capacities, available in more than 8 models and a wide range of options.

• Cooling system for the cooling zone.
• Sterilizing of the cooling zone.
• Automatic air balancing between aseptic and non-aseptic area of the tunnel.
• Shutter positioning monitoring and automatic adjustment are some of the options available to meet specific customer requirements.

Drying Zone

Glass containers entering the drying zone from the up-line washer are treated with clean vertical laminar air, vaporizes the moisture, pre-heats the containers and protect hot air back-flow from the hot zone.

Hot Zone

Glass containers then enter the hot zone and are subjected to a thermal cycle of sterilization and depyrogenation.

Cooling Zone

Glass containers further enter the cooling zone, where they are subjected to cold laminar air to bring down the temperature before entering the aseptic area.

Automation:

PLC Controlled and equipped with touch screen color graphics display for easy operator access to control screens and statistics, data storage and retrieval. Data management system is 21 CFR part 11 compliant.

Data screens feature, set parameters and current process parameters. Set parameters are stored in the form of recipes which are password protected and can be uploaded to current status as and when new type of glass containers are being processed.

Diagnostic screen highlight alarm conditions of the tunnel to enable the operator to minimize production down time.

Technical Specification of Depyrogenation Tunnel

* Power voltage can be adjusted as per customer’s domestic power voltage requirements.
* Rights of technical improvements & modification reserved.
* Illustrations & dimensions are shown for information purpose only.