Pharmacy Courses

Qualification of Depyrogenation Tunnel

The working principle of depyrogenation tunnel involves the use of high Temperature dry heat to sterilize and remove pyrogens from glassware, containers used in pharmaceutical manufacturing.

Parts of the depyrogenation tunnel

1. Loading area

2. Pre-heating zone

3. Heating zone

4. Cooling zone

5. Conveyor belt

5. Airflow system

6. Control system (a programmable logic controller (PLC) that regulates the temperature, conveyor belt speed, and other parameters of the depyrogenation process)

7.Safety features (interlocks, alarms, and emergency stop buttons are installed to ensure the safety of operators and prevent equipment damage)

Validation of the depyrogenation process

This process involves testing and monitoring the effectiveness of the tunnel in removing or inactivating endotoxins. This includes the use of biological indicators, such as bacterial endotoxin testing, to ensure that the process meets regulatory requirements. Use of high-efficiency particulate air (HEPA) filters: HEPA filters are used in depyrogenation tunnels to remove airborne particles, including endotoxins, from the air.

Validation and Qualification of Depyrogenation Tunnel 

Performance Qualification studies shall be carried out to ensure the equipment for proper operation and its ability to sterilize and depyrogenate the washed vials at the set parameters it's includes:

  • Air Velocity measurement
  • HEPA FILTER Integrity test by PAO Aerosol test
  • Air flow pattern test
  • Non-viable airborne particle count test
  • Heat Distribution studies
  • Heat Penetration studies
  • Endotoxin Challenge study

To qualify the test the equipment should fulfill the acceptance criteria

Validation Points

1. Heat Distribution

2. Temperature Uniformity

3. Cycle Time Establishing the appropriate cycle time to achieve the desired level of pyrogen removal or inactivation.

4. Conveyor Belt Speed

5. Biological Indicators (using biological indicators, such as bacterial endotoxin testing, to confirm the effectiveness of the depyrogenation process)


How does a depyrogenation tunnel work?

A depyrogenation tunnel works by exposing the equipment to high temperatures for a specific period of time, usually above 250°C, to destroy or inactivate pyrogens.

What are pyrogens?

Pyrogens are substances that can cause fever when introduced into the body. They can be found in various sources such as bacteria, bacterial endotoxins, and other microbial contaminants.

What are endotoxins?

Endotoxins are a type of pyrogen that are produced by Gram-negative bacteria and can cause fever and other adverse reactions in patients if present in pharmaceutical products.

What is the purpose of the cooling zone in a depyrogenation tunnel?

The purpose of the cooling zone in a depyrogenation tunnel is to cool down the equipment to a safe temperature before being unloaded.

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