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Sterilizing Tunnel for Ampoules & Vials

Home Sterilizing Tunnel for Ampoules & Vials

Sterilizing Tunnel for Ampoules & Vials

Sterilizing Tunnel for Ampoules & Vials

A Sterilizing Tunnel is an advanced, continuous dry heat sterilization system designed to depyrogenate and sterilize glass containers like ampoules and vials before aseptic filling.

Best Descriptions:

  1. It ensures microbial and endotoxin-free containers by passing them through a high-temperature tunnel with controlled airflow and temperature zones.
  2. Designed for integration into sterile production environments, it guarantees Class 100/ISO 5 conditions at the tunnel exit.
  3. This machine uses HEPA-filtered laminar airflows and precisely controlled heat to ensure container sterility without introducing moisture.
  4. Ideal for pharmaceutical manufacturers, it ensures compliance with GMP, FDA, and EU guidelines for sterile injectable production.
  5. The system is energy-efficient, with optimized insulation, air recirculation, and advanced temperature control.
  6. It eliminates human intervention in the sterilization process, significantly reducing the risk of contamination.
  7. Built with robust stainless steel construction and automation-ready interfaces for seamless integration.
  8. Offers real-time monitoring of airflow, temperature gradients, and belt speed to ensure consistent performance.
  9. A critical component of high-speed production lines, ensuring the aseptic integrity of ampoules and vials.

10 Frequently Asked Questions (FAQs) of Sterilizing Tunnel for Ampoules & Vials:

  1. What is the purpose of a Sterilizing Tunnel?
  2. How does it differ from autoclave sterilization?
    • Unlike autoclaves, it uses dry heat and continuous laminar airflow, avoiding moisture and reducing cycle time.
  3. What temperature does the tunnel operate at?
    • Typically between 250°C to 320°C in the hot zone, depending on process validation.
  4. Can it handle different vial or ampoule sizes?
    • Yes, most systems are adjustable or can be configured for different container formats.
  5. How is sterility assured in this system?
    • Through validated exposure times, HEPA filtration, temperature monitoring, and compliance with GMP protocols.
  6. Is it safe for heat-sensitive products?
    • The sterilizing tunnel is used only for empty glass containers, not filled products.
  7. What is a depyrogenation tunnel?
    • It is another term for a sterilizing tunnel, emphasizing the removal of pyrogens (bacterial endotoxins).
  8. What materials is it made from?
    • High-grade stainless steel (typically 316L), with cleanroom-compatible finishes.
  9. What is the belt speed range?
    • Variable belt speeds are offered, typically in the range of 1–10 meters/hour depending on tunnel design.
  10. Does it integrate with filling lines?
  • Yes, it is typically installed inline with washing machines and aseptic filling machines.

Applications of Sterilizing Tunnel for Ampoules & Vials:

  • Pharmaceutical Manufacturing: Sterilization of ampoules and vials for injectable drugs.
  • Biotechnology Labs: Sterile preparation of containers for sensitive biological products.
  • Vaccine Production Facilities: Ensuring pyrogen-free vials for vaccine filling.
  • Hospital Packaging Units: For preparing sterile vials in bulk hospital compounding operations.
  • Contract Manufacturing Organizations (CMOs): For multiple client product lines requiring validated sterility assurance.

Benefits of Sterilizing Tunnel for Ampoules & Vials:

  • Assured Sterility & Depyrogenation: Eliminates both microbial life and pyrogens from containers.
  • High Throughput: Continuous operation ideal for high-volume pharmaceutical production.
  • Moisture-Free Sterilization: Suitable for glass containers that must remain dry.
  • Fully Automated: Reduces human error and contamination risks.
  • Real-Time Monitoring: Integrated SCADA/PLC systems allow precise control and validation.
  • Energy Efficient: Recirculating air systems minimize heat loss.
  • Regulatory Compliant: Meets cGMP, US FDA, and EU guidelines.
  • Cleanroom-Compatible: Maintains ISO Class 5 conditions at the outlet.
  • Low Maintenance: Designed for long operational life with minimal downtime.
  • Customizable Design: Tailored lengths, zones, and throughput rates to meet specific production needs.

 

Contact us more details:

Call: +91 9825099693 +91 7949188303

Email: info@harsiddh.in

Address: 63, Adarsh Gold Industrial Estate, Near GVMM, Opp. CISF Camps Odhav, Ahmedabad - 382415, Gujarat, INDIA.

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