Sterilizing & Depyrogenation Tunnel

Sterilizing & Depryogenation Tunnel

Sterilizing & Depyrogenation Tunnel

This type of continuous sterilizer is a fully automated system specially designed which utilizes dry heat by means of forced convection of filtered air, through high efficiency particulate air filter to achieve sterilization and dehydrogenation of washed empty pharmaceutical glassware used of parenteral product packing.

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Dimensions
Depending on model

Purpose:
Sterilization/dehydrogenation tunnels for vials, syringes and ampules

Vial Range
2-100ml

Output
Varies depending on model

Changeover
Varies depending on model

Salient: Features
  • In fewer than 30 minutes, an untreated vial goes from ampoule/vial washer to sterilizing tunnel to cleanroom, entering in a sterilized microorganism- and pyrogen-free state
  • Requires no operator intervention or recontamination
  • Typical operating temperature of the tunnel is 320°C
  • Heat is generated by silicon-controlled rectifier (SCR) heating elements
  • Depending on the format, vials stay inside the sterilizing/dehydrogenation chamber for approximately 6-10 minutes
  • No format parts are required
  • This is essentially a set-it-and-forget-it automatic process
  • There are 3 chambers: pre-heating chamber, sterilizing chamber, and cooling chamber
  • Chambers of the tunnel are separated by gates and the height is automatically set by the PLC as part of the vial recipe
  • HEPA filters are tested for efficiency by the “DOP” test procedure (each chamber of the tunnel has provisions to conduct the DOP test)
  • Each chamber is equipped with a pipe below the filters to allow for particle counting

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Sterilizing & Depyrogenation Tunnel FAQs

It is a continuous inline hot air system that sterilizes and destroys endotoxins in glass containers, ensuring injectable packaging is sterile and pyrogen-free before aseptic filling.

Depyrogenation destroys bacterial endotoxins that survive normal sterilization and can cause severe patient reactions. High-temperature dry heat ensures safe injectable packaging.

Vials move through pre-heating, high-temperature sterilization, and HEPA-filtered cooling zones on a conveyor, exiting sterile and ready for aseptic filling.

Typically 300°C–350°C in continuous tunnels, achieving ≥3-log endotoxin reduction as mandated by global regulations.

Yes — validated dry heat depyrogenation is mandatory for glass containers used in sterile injectable manufacturing.

Yes — especially for sterile herbal injectables requiring endotoxin-free glass containers.

It ensures sterile, contamination-free glass packaging for premium serums and ampoule-based cosmetic products.

Pre-heating zone, sterilization/depyrogenation zone, and HEPA-filtered cooling zone.

ISO Class 5 (Grade A) cooling zone with H14 HEPA filters ensuring sterile exit conditions.

Through IQ/OQ/PQ qualification, temperature mapping, endotoxin challenge testing, and HEPA integrity testing.

Typically 2 ml to 500 ml vials, ampoules, and glass bottles with adjustable conveyor settings.

Speed determines dwell time in the high-heat zone — critical for achieving validated endotoxin reduction.

From 3,000 to 60,000+ vials per hour depending on model and configuration.

HEPA-filtered unidirectional airflow maintains sterile conditions as vials exit toward the filling area.

SS 316L internal construction with high-temperature insulation and GMP-compliant materials.

Yes — designed for seamless inline integration between washer and aseptic filling machine.

Yes — includes 21 CFR Part 11 documentation, validation protocols, and audit-ready data logging.

3-phase power, compressed air, HVAC integration, and BMS monitoring compatibility.

Annually, or after major maintenance, HEPA replacement, or conveyor modification.

Selection depends on vial sizes, throughput, cleanroom layout, regulatory targets, and future scalability.

What Our Clients Say About Us?

Our clients' feedback is always important for our growth.

We've been using the Manual Capsule Filling Machine from Lodha International LLP for months now. It's efficient and easy to operate. Great value for the investment!

The Automatic Capsule Loader from Lodha International has transformed our production process. It saves us so much time and provides consistent results. Highly recommend it!

Our production line is working much more smoothly, thanks to Lodha International LLP and their Ampoule Filling & Sealing Machine. It's built to last, and the results are always precise.

Our packaging process has never been more efficient since we invested in Lodha International LLP's pharmaceutical packaging machinery. The machinery is reliable and user-friendly. We couldn’t be happier.

We switched to the Automatic Capsule Filling Machine from Lodha International LLP, and the difference is clear. The machine delivers exceptional precision and speed. It greatly enhanced our industrial productivity.

We’ve been using the Manual Capsule Filling Machine for several months and are very impressed with its performance. It's robust, easy to maintain, and ideal for our needs. Highly satisfied with Lodha International LLP.

The Automatic Capsule Loader from Lodha International revolutionizes the industry. It increased our production speed significantly while reducing human error. It is an excellent investment for any pharma company.

We’ve been using Lodha International LLP’s Ampoule Filling & Sealing Machine for a while, and it has exceeded our expectations. The machinery is highly effective in our filling processes.

The Pharmaceutical Packaging Machinery from Lodha International LLP has greatly improved our packaging line. It’s efficient, high-quality, and easy to integrate into our existing system. Highly recommend their products!

We recently upgraded to the Automatic Capsule Filling Machine from Lodha International LLP. The machine is fantastic—fast, precise, and cost-effective. It has made an important difference in our manufacturing quality.

The pharmaceutical machinery from Lodha International LLP. has completely transformed our production line. Excellent performance and long-lasting quality—highly recommended!

Exceptional quality and service! The pharmaceutical machinery delivered consistent output and helped streamline our processes.

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