Sample Requirements
USP requires 3% of the production lot with a minimum of 3 and maximum of 10 devices to be pooled and tested. For liquid samples, a minimum of 0.6 ml is required and powder sample require enough material to reconstitute into a minimum of 1 ml pyrogen-free water. Initial validation on 3 lots must be performed in order to validate the method of testing for a given product.
Samples containing B-Glucans (carbohydrates, mold, starch, plant material, food supplements) interfere with the pyrochrome and produce falsely elevated endotoxin levels. Please inform the laboratory if your sample contains carbohydrates or B-glucans. A special buffer is used to resuspend the pyrochrome in order to overcome the nonspecific interference. There is an additional $30 per sample for samples requiring the special re suspension buffer.
The Charles River Endosafe PTS System:
The Endosafe®-PTS™ was used to determine the level of endotoxin in the test article. The PTS™ utilizes LAL reagents in an FDA-licensed disposable test cartridge with a handheld reader for a completely contained, real-time endotoxin testing system.
Under GLP Conditions – Protocol # CB129A
Under Non-GLP Conditions - Protocol # CB130A