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Sterilization tunnels (depyrogenation tunnels)are important in ensuring pharmaceutical equipment is sterile by moving equipment through a high-heat tunnel at a predetermined rate. These tunnels must be validated periodically to ensure the heat inside is at the rate it should be.
Depyrogenation is mainly used in the sterilization of vials for aseptic filling. The process is also useful to sterilize assembled and packaged materials, since heat conduction does not require the contact of the product with steam or water. Depyrogenation refers to a process that removes pyrogens, which are fever (pyrexia) causing substances. This process is used on instruments, devices, pharmaceuticals (and containers thereof). Namely, those that will come into contact with a person's body.
A typical cycle would be 30 minutes at 250°. The description of the dry heat depyrogenation cycle and duration for specific load items shall be included in written documentation in the compounding facility. The effectiveness of the dry heat depyrogenation cycle shall be verified using endotoxin challenge vials (ECVs).
The process of hot air sterilization and depyrogenation tunnels involves the removal of pyrogens from solutions or surfaces by means of controlled exposure of glass containers to high temperatures. Our tunnels are equipped with convection heat transfer and provide high production output with evenly and precise distribution of heat over glass vials, cartridges, syringes, and infusion containers.
Our depyrogenation tunnels are specially designed to be installed between a washing and a filling or packaging system (dependent on end user requirements). These high output tunnels count on precise temperature control and heat distribution to ensure full sterilization of glass containers before they are aseptically filled.
Sterilization is achieved in accordance requirements, by a laminar flow of filtered hot air, environment, throughout the complete tunnel length.
The tunnels are composed of three main chambers: inlet chamber, hot chamber, and cooling chamber, with the possibility to add a fourth chamber for further cooling.
The perfect balance flow of airflow conditions ensures the stability and uniform distribution of temperature offering safe and reproducible operations, with continuous in-process control and validation of the system.
All our equipment is fully compliant with strict pharmaceutical standards including cGMP and ISO.