The Charles River Endosafe® Series of Bacterial Endotoxin Detection Systems are designed for rapid quantitative endotoxin testing using unique, state-of-the-art cartridge technology. Today, more than 6,000 Charles River cartridge systems have been implemented around the world, and Endosafe® technologies are used by such global giants as Baxter, Pfizer, Roche, AstraZeneca, etc.
The cartridge technology for bacterial endotoxin control is based on the pharmacopoeial kinetic chromogenic method in a modification using disposable polystyrene cartridges filled with pre-calibrated reagents. The cartridges contain repeatable channels for sample introduction and positive control and are characterized by a sensitivity range of 0.005 to 50 EU/ml. The use of LAL cartridges with Endosafe® systems reduces test time to 15 minutes, simplifying product quality analysis, increasing test efficiency, and providing fast, accurate, reproducible results. Endosafe® cartridges are licensed by the U.S. FDA and recommended for use in accordance with USP BET<85> and EP BET<2.6.14>.
Cartridge technology has a number of advantages over traditional methods, including short test times, quantitative reproducible results, and a simple test protocol. In addition, the cartridge technology uses only 1/20 of the raw materials required for a traditional test, significantly reduces labor-intensive test preparation, and does not require special training and staff training.
| Method. | Test duration | Main advantages | The main disadvantages |
| Gel thrombus | 60 min + 30 min test preparation | Does not require special equipment, relatively low test cost | Subjective qualitative results, dependence on the “human factor,” lengthy test administration, the need for a large number of reagents and consumables |
| Traditional kinetic test | 60 min + 30 min test preparation | Accurate quantitative objective results | Lengthy testing, complex testing protocol, need for special equipment |
| Cartridge technology | 15 min + 2 min test preparation | Reproducible quantitative objective results, significantly shorter test time, simple method protocol | The need for special equipment |
The Charles River Endosafe® series of endotoxin testing systems includes three types of systems with different configurations: the nexgen PTS portable system that can test a single sample for up to 15 minutes, the nexgen MCS modular system that can test up to five samples in parallel, and the Nexus robotic system with a test capacity of up to 60 samples in 15 minutes.
