What is difference between depyrogenation and sterilization?

What is difference between depyrogenation and sterilization?

Sterilization is any process that removes, kills, or deactivates microbes, whereas depyrogenation is a process that eliminates pyrogens. The most prevalent and problematic pyrogens are the bacterial endotoxins found in the outer cell walls of gram-negative bacteria.

What is depyrogenation tunnel?

Super-hot ovens, called Depyrogenation Tunnels, are used to generate the necessary heat. Glass vials, used for the storage of pharmaceuticals, are placed in the tunnel, where they travel through various heat zones and are subjected to extreme, dry heat, ridding them of the pyrogens.

What is sterilization tunnel?

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.

What is FH value in tunnel?

The Fh value will be calculated based on the temperature recorded by the thermocouple inside the container at the coolest area of the load. Upon completion of the cycle, the Fh value will indicate whether the cycle is adequate or if alterations must be made.

What is depyrogenation process?

Dry heat sterilization (or Depyrogenation) is a process aimed at the reduction in the level of pyrogens with the use of hot air in temperature ranging from 160°C up to 400°C. The temperature used depends on the duration of the process. Gravity or mechanical heat convection can be used for this process.

Why is depyrogenation important?

Depyrogenation, the reduction of bacterial endotoxin, is critical in preparing packaging components for use in injectable drug products. Pharmaceutical packaging components such as ampoules, vials and stoppers require specific depyrogenation procedures appropriate for the component’s material.

How do you calculate conveyor tunnel speed?

For speed calculation of conveyor belt ,we use width of the tunnel(conveyor belt width),but not the length. when we take tunnel length and width to count total vials in the tunnel, in that situation we have to calculate tunnel length÷ vial dia(this can show us total rows in tunnel).

What is FH in Depyrogenation?

Fh Value. Evaluates the effectiveness of Steam Sterilization. Evaluates the effectiveness of Dry Heat Sterilization. The assumed z-value is 10°C for sterilization range of 100 to 130°C. The assumed z-value is 20°C for sterilization range of 160 to 200°C.

What is depyrogenation temperature?

200.0℃ to 400.0℃.
Depyrogenation is a sterilization method that uses HOT AIR and is set at high temperatures from 200.0℃ to 400.0℃. However, in most cases the process settings are determined to be typically at within 200.0℃ to 250.0℃ for 10.0mins. This is mainly used to sterilize vials, glasses and ampoules.

What is depyrogenation by dry heat?

Dry heat sterilization (or Depyrogenation) is a process aimed at the reduction in the level of pyrogens with the use of hot air in temperature ranging from 160°C up to 400°C. The temperature used depends on the duration of the process.

How depyrogenation can be done?

Depyrogenation can be defined as the reduction of pyrogenic substances, including bacterial endotoxin, and is generally achieved by removal or inactivation….Depyrogenation.