Endotoxin Challenge Vials (Endotoxin Indicator)

2019-08-05

Endotoxin Challenge Vials (Endotoxin Indicator) is always employed by pharmaceutical manufacturers to do GMP verification.

Therefore, let’s talk about GMP at first. GMP, the abbreviate of Good Manufacturing Practice, is defined as a kind of regulation by World Health Organization to guide production and quality control of foods, medicines and medical products. GMP requires manufacturers like pharmaceutical companies and food enterprises to have good equipment, reasonable production process, complete quality control and strict detection system.

Endotoxin Challenge Vials (Endotoxin Indicator), also known as ECV, plays an important role in ensuring complete quality control and strict detection system. Use Endotoxin Challenge Vials during oven test, then detect whether the endotoxin in the Endotoxin Challenge Vials has been reduced to the required one after oven test. It will offer useful information for pharmaceutical companies or food enterprises to monitor product quality.

Bioendo has both Endotoxin Challenge in Ampoule and Endotoxin Challenge in Vial. At present, Bioendo has greatly improved the Endotoxin Challenge in Vial. The seal cap, stopper and label of Bioendo Endotoxin Challenge in Vial are heat resistant. This means that seal cap, stopper and label do not need to be remove 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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