Validation of Removing Heat Source

2020-09-03

Dry heat sterilizer is crucial for pharmaceutical factories producing parenteral drug. Sterilization and sterility assurance of compendial articles on American Pharmacopoeia recommends Endotoxin Challenge Vials (Endotoxin Indicator) to do related validation of removing heat source. Here we will introduce BIOENDO Endotoxin Challenge Vials (Endotoxin Indicator).


According to Sterilization and Sterility Assurance of Compendial Articles, Endotoxin Challenge Vials containing at least 1000EU endotoxin level should be employed to do related validation, and the potency of such Endotoxin Challenge Vials should be reduced at least 3 log.

BIOENDO has Endotoxin Challenge Vials packed in both ampoule and vial.

For BIOENDO’s Endotoxin Challenge Vials (in Vial), heat-resistant seal cap, stopper and label are used. This means you don’t need to remove them during verification of depyrogenation. Meanwhile, the seal cap of Bioendo Endotoxin Challenge in vial is red before verification, but it turns to light red or even white after verification. This will help users to easily distinguish the used Endotoxin Challenge in Vial from the unused one.

Xiamen Bioendo Technology Co., Ltd.

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