Lonza is the industry leader in innovations for endotoxin detection products, services and software. Using our extensive experience with endotoxin detection and its regulatory requirements, we developed an integrated system to support quantitative endotoxin detection. Each system component has been validated and can be verified.
Two plate readers have been validated as part of our quantitative endotoxin detection systems. These 96-well plate readers feature sample compartments with uniform temperature from well to well, and both readers seamlessly interface with our WinKQCL™ Software.
ELx808™ Reader: Absorbance Plate Reader for Kinetic-QCL™ and PYROGENT™ – 5000 Kinetic LAL Assays
For the kinetic assays, the ELx808™ Reader is highly reliable and easy to use. It features fully-automated reading of 96-well plates. The incubator of the ELx808™ Reader incorporates a zonal heating system that offers excellent temperature uniformity, a critical factor in enzymatic assays. This reader can also be used as a standard spectrophotometer and can read results from Lonza’s QCL-1000™ Endpoint Chromogenic LAL Assay.
The ELx808™ Reader can be purchased separately, or as a part of the Standard Kinetic System that includes WinKQCL™ Software, a computer, monitor and printer.
FLx800™ Reader: Fluorescence Plate Reader for PyroGene™ recombinant Factor C Assay
The FLx800™ Reader is part of the quantitative endotoxin detection system that features the PryoGene™ rFC Endpoint Fluorescent Assay. PyroGene™ rFC is an innovative assay method that utilizes recombinant technology for the detection of endotoxin. Recombinant Factor C is a synthetic version of the same enzyme in the LAL cascade that is activated by endotoxin with a fluorescent signal for detection. The reaction is run in a 96-well plate and measured at time zero and after a one-hour incubation in a fluorescent microplate reader using excitation/emission wavelengths of 380/440 nm.
The PyroTec™ Liquid Handling System is a robotic workstation to help automate endotoxin detection testing. This system can be tailored to your testing needs and helps high throughput labs manage their daily sample requirements.
WinKQCL™ Software is fully integrated with the Tecan® Freedom EVOware™ software, allowing assay templates to be executed using robotic scripts for the PyroTec™ Liquid Handling System. WinKQCL™ Software supports all of the endotoxin detection assays from Lonza and allows the user to run all of the endotoxin detection tests typically run in a Quality Control laboratory:
- Initial Qualification
The endotoxin detection instruments and software from Lonza come fully supported with an Installation, Operational and Performance Qualification (IOPQ) manual and a WinKQCL™ Software validation package. In addition, a trained specialist from Lonza can perform the IOPQ of the complete system to help customers with the system validation process.
In addition, On-site Service and Preventative Maintenance contracts are available to help ensure that your instrument is working properly.