Description
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).
Sterilizing & Depyrogenation Tunnel: Ensuring Sterile Pharmaceutical Containers
The Sterilizing & Depyrogenation Tunnel by Adinath International is designed for the continuous sterilization and depyrogenation of glass ampoules and vials. This equipment is essential in pharmaceutical manufacturing, ensuring containers are free from contaminants before filling.
Design and Construction
Constructed with high-quality stainless steel, the tunnel features a stainless steel wire conveyor belt that transports containers from the washing machine (non-sterile area) to the filling line (sterile area). Each independent filter plenum includes filter integrity sample ports, allowing for routine validation and maintenance.
Operational Zones
The tunnel operates through three distinct zones:
- Preheating Zone: Gradually increases the temperature of containers to prevent thermal shock.
- Sterilization Zone: Maintains high temperatures to achieve sterilization and depyrogenation.
- Cooling Zone: Reduces the temperature of containers, preparing them for aseptic filling.
This zoned approach ensures effective sterilization while maintaining container integrity.
Control and Monitoring
Equipped with a PLC system and touch screen color graphics display, operators can easily access control screens and statistics. The data management system complies with FDA requirements, ensuring secure data storage and retrieval. Set parameters are stored as recipes, which are password protected and can be uploaded when processing different glass containers.
Safety Features
The conveyor belt is monitored, and an alarm activates if it operates outside set speed points. Each filter module has differential pressure gauges to monitor pressure, with pressure switches featuring high and low alarms. Ports are provided to allow the introduction of validation thermocouples in each zone, facilitating accurate temperature monitoring.
Energy Efficiency
When not in use, the tunnel can operate in night-mode to save energy while preventing contamination. This feature reduces operational costs and aligns with sustainable manufacturing practices.
Salient Features of Sterilizing & Depyrogenation Tunnel
Process Operation of Sterilizing & Depyrogenation Tunnel
PLC Controlled and equipped with touch screen colour 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.
Technical Highlights
- Models: ADST-450, ADST-600, ADST-900
- Belt Width: 450 mm (ADST-450), 600 mm (ADST-600), 900 mm (ADST-900)
- Installed Power: 30 kW (ADST-450), 45 kW (ADST-600), 60 kW (ADST-900)
- Power Supply: 3 Phase / 4 Wire
- Control Voltage: 24 VAC/DC
- Dimensions: 3700 mm (L) for ADST-450, 4500 mm (L) for ADST-600, 5100 mm (L) for ADST-900
These specifications cater to various production scales, allowing manufacturers to select a model that fits their operational needs.
Integration and Compatibility
The tunnel is designed to integrate seamlessly with upstream washing machines and downstream filling lines. This compatibility ensures a continuous, contamination-free transfer of containers, enhancing overall production efficiency.
Applications
Primarily used in the pharmaceutical industry, the Sterilizing & Depyrogenation Tunnel is suitable for:
- Glass Ampoules: Ensuring sterility for injectable solutions.
- Glass Vials: Preparing containers for vaccines and other sterile pharmaceuticals.
Its ability to handle various container sizes makes it versatile for different production requirements.
Maintenance and Validation
The design includes provisions for easy maintenance and validation. Filter integrity sample ports and validation thermocouple ports facilitate routine checks, ensuring consistent performance and compliance with regulatory standards.
Overall, Adinath International’s Sterilizing & Depyrogenation Tunnel offers a reliable solution for sterilizing glass containers in pharmaceutical manufacturing. Its advanced features, compliance with industry standards, and energy-efficient operation make it crucial for maintaining product sterility
Technical Specification of Sterilizing & Depyrogenation Tunnel
| Model | ADST-450 | ADST-600 | ADST-900 |
| Belt Width (mm) | 450 | 600 | 900 |
| Installed Power (kw) | 30 | 45 | 60 |
| Power Supply | 3 Phase / 4 Wire | 3 Phase / 4 Wire | 3 Phase / 4 Wire |
| Control Voltage | 24VAC/DC | 24VAC/DC | 24VAC/DC |
| Dimension | 3700mm(L) | 4500mm(L) | 5100mm(L) |
| 1275mm(W) | 1500mm(W) | 1800mm(W) | |
| 2350mm(H) approx. | 2350mm(H) | 2350mm(H) | |
| approx. | approx. |
* 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.
