Injectable are one of the highly critical products in the pharmaceutical industry and have more impact than non-injectable or liquid products. They are sterile drug products directly injected into the human body for dosing purposes, and for this purpose. To ensure product safety they are subject to strict sterility and sterilization processes typically more than that of liquid dose.
Among many, sterilization is a process that is carried out during the manufacturing process of injectable products at various stages; some examples include empty ampoules/vials, terminal sterilization, and the like. The depyrogenation tunnel is slightly older, yet it is an innovative way of sterilizing empty ampoules/vials before the product fills them.
A depyrogenation tunnel is commonly part of a combined washing-sterilization-filling line for producing the filled ampoules or vials of injectable products. A depyrogenation tunnel can be used for both ampoules and vials.
What is a depyrogenation Tunnel?
A depyrogenation tunnel ensures sterilization and depyrogenation of glass containers used in injectable products using high-temperature air at around 300?C. The temperature in the tunnel is controlled at a set point. The glass containers continuously travel on a conveyor belt as they are sterilized and are discharge at clean side at the input fed of filling machine.
The temperature is gradually increased up to the set point, and after sterilization, the temperature is cooled down for easy handling by humans. The different temperatures are generated simultaneously at various tunnel zones, and they perform their function when glass containers pass through these regions.
The glass containers enter from one side enter, pass through different temperature zones, and are discharged from the machine. The inside of the tunnel is air-tight so that outside air does not penetrate the tunnel and inside air does not leak to the outside environment.
The depyrogenation tunnel is connected to the washing and filling machine – the washed containers enter the tunnel, while sterilized containers enter the filling machine.
What is the purpose of a depyrogenation tunnel?
The primary purpose of a depyrogenation or sterilization tunnel is to eliminate all pyrogenic substances involving high temperatures using dry air.
Endotoxins pose a risk to sterile products administered through intravenous or intrathecal, and the sterile manufacturing process includes measures to reduce endotoxins as a part of safety and quality enhancement procedures. Additionally, during the fill/finish process, glass containers (used to fill product in it) must be dehydrogenated using dry heat at high temperatures. The traditional method to perform this purpose is an Oven or Dry Heat Sterilizer – DHS, and the newest method is a depyrogenation tunnel.
Depyrogenation by tunnel is a quality test to prevent endotoxins from becoming part of medicine. Because it is possible that glass containers could contain these endotoxins that could result in immunological responses from the human body, causing infection.
Construction of depyrogenation tunnel
Some critical parts of the tunnel include the following
Body
The body of the depyrogenation tunnel is made of stainless steel. The glass containers' contact parts are made up of SS 316L to prevent affecting the physical characteristics of glass containers. Non-contact parts are made of SS304.
The body encloses all the critical sections, such as electrical and mechanical. All cycles occur in an enclosed body structure.
Belt
A metallic belt is installed inside the tunnel to transfer glass containers from pre-heating to heating to cooling zone. The belt moves at a defined speed. The belt speech d depends on the time required for glass containers to be exposed to temperature values.
The speed of the belt is adjustable and can be increased/decreased depending on the product requirements.
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