Depyrogenation:- Depyrogenation is a process to make a solution pyrogen-free. It is usually done in an injectable solution before filling. The processes of depyrogenation vs sterilization both are used in injectable manufacturing and filling sections.
Dry heat depyrogenation is a temperature- and time-dependent process. Depyrogenation using dry heat can be accomplished in a batch oven mode or in a continuous process using a tunnel system. Depyrogenation in ovens is typically performed at temperatures in excess of 170o C.
Tunnels for depyrogenation ordinarily operate at higher temperatures. -USP <1228>
Difference between depyrogenation and sterilization:
Depyrogenation is a process to eliminate pyrogens from an injectable solution. Whereas sterilization is the process where all pathogenic or non-pathogenic microorganisms, bacteria, fungi, and protozoa are destroyed by heat, pressure, and vapourization.
Both processes are highly sensitive and results-oriented. The difficulty level in depyrogenation vs sterilization is almost similar, sometimes depyrogenation is found tougher.
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How does a depyrogenation tunnel work?
Depyrogenation is performed in special capacity ovens and tunnels, there we can depyrogenate or sterilize the glassware which is used for filling pharmaceutical injectables.
Depyrogenating ovens and tunnels eliminate the endotoxins by direct heat through physical destruction. In this process, the molecule of endotoxin is killed at high temperatures.
Does autoclaving destroy endotoxins?
Autoclaving is a very efficient process for the sterilization of products and glassware. Due to some limitations in glassware sterilization and depyrogenation, some traces of pyrogens were found alive after autoclaving. Such endotoxin traces remain in the corner of glassware. Depyrogenation in the autoclave is not a foolproof process.
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How to get rid of pyrogen?
Dry heat depyrogenation is found a more efficient method than autoclave glassware. It is believed that heating glassware at a temperature of 650o C for 1 minute or more is sufficient to kill all endotoxins.
Another method is to heat the glassware for 250 OC for more than 45 minutes is also complete depyrogenation.
And, the third range is at a temperature of 180oC for 4 hours heating is also proven completely eliminate of endotoxins. Some studies show that heating at 250o C for 30 minutes is effective depyrogenation.
What are the depyrogenation tunnels?
In the pharmaceutical manufacturing industry where injectable is filled in glass vials, those glass vials should be sterile and pyrogen-free.
To meet the big large capacity requirement of sterile and pyrogen-free vials specially designed tunnels are made for this process. In these tunnels, unidirectional hot air at 350 o C is supplied to trays of empty vials to depyrogenate vials, ampoules, and cartridges.
Is pyrogen-free mean sterile?
A product, glassware, or equipment is called sterile if it is free from microorganisms, fungi, and bacteria, Otherside being pyrogen-free is a state free from endotoxins and free from fever-causing substances.
The states are slightly conditional and different from each other.
How do you detect endotoxins?
To detect and quantify the endotoxins LAL in vitro and RPT in vivo tests is applied. As per FDA regulation in medical devices, contamination from endotoxin is counted as acceptable up to 0.5 endotoxin units per ml.
Why endotoxin are so harmful?
When gram-negative bacteria are killed by any antibiotic in the human body then endotoxins are released. Therefore, gram-negative bacteria infection is very dangerous for us.Â
It initiates several risks like septic shock that may result in death. The LPS layer of gram-negative bacteria contains lipid-A.
The fatal endotoxin lipid-A is a component of endotoxin which is the toxic part of gram-negative bacteria.
Types of depyrogenating tunnels:
Blue Galaxy depyrogenating tunnels:- Blue galaxy depyrogenating tunnels are installed on the production line of the pharmaceutical company. They supply continuous depyrogenated glass vials.
Bosch HQL drying and depyrogenation tunnels: Bosch HQL tunnels provide unidirectional hot airflow. This type of tunnel provides process temperature, and progression curves, and reduces the time of depyrogenation time.Â
This category tunnel ensures repeatable accuracy which is very necessary for validation of tunnels.
These category tunnels are made for use in stable and non-stable container depyrogenation.
Conclusion:
The concept of depyrogenation vs sterilization is very vast and deep in the information. Depyrogenation is an essential process in the pharmaceutical manufacturing industry other hand sterilization is the backbone of the quality of pharma products. These two terms are not against each other rather they enhance the impact of each other. Â
References:
- Endotoxin control in depyrogenation tunnels.
- USP<1128> Depyrogenation
- Tsuji K, Harrison S. Dry heat destruction of lipopolysaccharide: dry heat destruction kinetics. Appl Environ Microbiol. 1978; 36(5):710–4.
- Depyrogenation-USP<1228>
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