A combination of processes where sterilization and depyrogenation of glass vials, bungs, and rubber closures take place by hot air in a balanced way to reduce the time of the process is known as Depyrogenation tunnels. These tunnels are used in injectable formulation plants where the job of sterilization of empty containers for injection products is completed. There are lots of companies to provide the best depyrogenation tunnels in injection plants.
A tunnel system equipped with convection heat transfer provides high production output with evenly and precise distribution of heat over glass vials, cartridges, syringes, and infusion containers.
Deyrogenating tunnels are designed for cleaning (internally & externally) and drying both glass and plastic containers in the pharmaceutical formulation industry.
In the whole tunnel system washing machines are available in custom dimensions and with different gripping systems to meet the specific requirements. The washing machines can be integrated with sterilization tunnels and packaging lines for a complete modular processing line.
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What is the depyrogenation process?
In fact, Dry heat sterilization is also known as Depyrogenation which is a method of reducing pyrogen levels in the vials used for aseptic filling for injectable drugs.
Dry heat sterilization in autoclaves is time killing process where lots of time is required for the sterilization of a batch of vials. It takes time to get cold before feeding on the feeling machine, on the other side in the Depyrogenation tunnel the whole process of sterilization, cooling, and feeding takes place simultaneously without any touch of the human hand. The speed of sterilization in the depyrogenation tunnel is very high due to the high temperature and automation process.
Depyrogenation tunnels zones
In the depyrogenation tunnel there are three zones; Blue Zone = cooling zone, Red Zone = Hot depyrogenation zone, Orange Zone = pre-heat zone.
Vial depyrogenation tunnel validation
To establish the validity of the Depyrogenation tunnel vial first you have to do a Performance qualification test of the Depyrogenation tunnel. Some performance qualification studies are to be carried out to ensure the equipment’s proper operation and capabilities to sterilize and depyrogenate the vials. Following parameters to be checked
- Air Velocity measurement.·
- HEPA FILTER Integrity test by DOP / PAO Aerosol test.·
- Airflow pattern test.
- Non-viable airborne particle count test.
- Heat Distribution studies.
- Heat Penetration studies.
- Endotoxin Challenge study.
Depyrogenation tunnel HEPA filters
In the dry heat sterilization and depyrogenation processes, the quality and durability of HEPA filters are the very critical thing. The role of HEPA filters remains very indispensable to protect containers like vials and filled syringes from contamination that can lead to a serious challenge to the quality of the medicines.
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The author has 20 years of experience in the Pharmaceutical Manufacturing Companies. Have exposure to all audit documents for WHO-GMP, PIC/S, USFDA, Export documents, US-FDA documents, Validation of Pharma machinery, and Quality Control Instruments. Expert in Pharma Plant Setup and sale and acquisition of running pharma company.