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SOP FOR DEPYROGENATION

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1.0  OBJECTIVE : This procedure is laid down for depyrogenation of glass wares for Bacterial Endotoxin test to make them free from any endotoxin and hence to avoid any false positive results.

2.0 SCOPE : This procedure is applicable for depyrogenating the glass wares for bacterial endotoxin test.

3.0RESPONSIBILITY : Microbiologist, QC In charge.

4.0 REQUIREMENTS : 10 x 75 mm flint glass test tubes, Borosilicate glass tubes for dilution preparation, glass pipettes, Depyrogenation oven etc.

5.1  PRECAUTIONS:

5.1.1 Depyrogenate the glass wares at 250°C for 1 hour to ensure the removal of any endotoxins, if present on the surface.

5.1.2 After depyrogenation, take care not to expose the glass wares as such for longer time open at the time of use and do not touch with hands.

5.1.3  Do not keep the plastic wares in de-pyrogenation oven.

5.2 DEPYROGENATION PROCEDURE:

 5.2.1  Switch on the mains power.

5.2.2  Switch ‘ON’ the power of de-pyrogenation oven. And set the temperature at 250°c.

5.2.3  Take properly cleaned and dried glass-wares. Place the 10 x 75 mm glass tubes in a beaker and cover with a lid of Petri dish or wrapped in aluminium foil or keep them in dedicated S. S. box.

5.2.4  Put the pipettes in S.S. box or wrap in aluminium foil.

5.2.5  Keep the glass wares to be de-pyrogenate in oven and properly close the door.

5.2.6 After achieving the temperature, continue keep the glass wares for 1hour at 250ºC to de-pyrogenate.

5.2.7 Put all these glass wares for depyrogenation in oven at 250°C for not less than 1hour.

5.2.8 After depyrogenation switch off the oven, allow the glass wares to cool and then transfer all the requirements to micro lab. Maintain the record.

FIND MORE AT…

Reference links

http://www.ivtnetwork.com/sites/default/files/Depyrogenation.pdf

http://www.americanpharmaceuticalreview.com/Featured-Articles/148858-A-Comparative-Study-of-Different-Methods-for-Endotoxin-Destruction/

 

 

 

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