What is depyrogenation process?
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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.
What are methods for depyrogenation?
Not all substances can withstand such heat without being destroyed, so alternative methods of depyrogenation include:
- Ionizing radiation.
- The use of binding agents.
- Ultrafiltration.
- Ion exchange.
- Oxidation via hydrogen peroxide.
- Caustic agents like sodium hydroxide.
- Chemical deactivation via acid-base hydrolysis.
Why is depyrogenation done?
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.
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.
How do you sterilize endotoxins?
Endotoxins are highly resistant to sterilization processes. Presently, the only procedure recommended by the United States Pharmacopeia (USP) is dry heat at 250°C for 30 min or 180°C for 3 h, which is completely unsuitable for polymeric, and even metallic, materials (Nakata, 1993; Cookson et al., 1997).
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 Fd value for depyrogenation?
The theoretical requirement for Depyrogenation is 250°C at 30 min. with the z-value assumed as 46.4°C (see the comments)….Depyrogenation is Different.
| Parameter | Dry Heat Sterilization | Depyrogenation |
|---|---|---|
| Value | Fh value | Fd value |
| Formula difference | T -(minus) 170°C | T-250°C |
| z-Value | z = 20°C | z = 46.4°C |
What is a depyrogenation oven?
Depyrogenation oven is widely used in biotechnology research and development for dry heat sterilization of pharmaceutical components and products. This process is often applied on heat-stable oils, ointments and powders and also on heat-stabile components, glassware and metal parts etc.
Does sterile filtration remove endotoxins?
The conventional heat sterilization of liquids and filtration with microporous membrane filters, which kill or remove whole bacterial cells, do not eliminate bacterial endotoxins (10, 11).
What is tunnel sterilization?
Sterilization tunnels (depyrogenation tunnels) are important in ensuring pharmaceutical equipment is sterile by moving equipment through a high-heat tunnel at a predetermined rate.
