Hemodialysis can sustain the life of a patient; however, it can cause life-threatening issues if the treatment water is contaminated. Dialysis water testing for endotoxins is essential to patient safety. If certain amounts of endotoxin are introduced into the bloodstream or spinal fluid via a parenteral drug or medical device, fever, septic shock, organ failure, or even death can occur. Make sure your dialysis water is safe.

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Hemodialysis treatment after dialysis water testing for quality control

Patients trust you to administer their treatments safely, and their lives depend on the precision and sensitivity in your testing procedures. Improve the safety and quality of the water you use in your dialysis treatments. Comprehensive QC testing solutions, including dialysis water testing, are available to facilities specializing in dialysis.

Our rapid test methods improve dialysis water testing, decrease testing time, and accelerate production. We offer a line of single-step testing systems that include assays for quick and quantitative endotoxin analysis, glucan contamination testing, and Gram identification right at the point of sample collection.

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women receiving dialysis

Webinar: Endotoxin: Control, Analysis and Clinical Relevance

Advance your understanding of the harmful effects of endotoxins and how to control them through simple, rapid, and quantitative endotoxin testing in dialysis products.

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Our bacterial endotoxin testing services laboratory offers comprehensive dialysis water testing and support services to help improve the compliance and efficiency of your program and help you to achieve control, consistency, and precision in your lab. Our labs are FDA-registered and offer a variety of CGMP testing and support services.

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  • Product validation programs
  • LAL proficiency testing program
  • Regulatory compliance consultation
  • Methods development
  • On-site training
  • Reader/software qualification
  • Product release/stability testing
  • Sample preparation
  • Routine endotoxin detection for non-release applications
  • SOP and protocol writing

Monitor your renal care center against bacterial contamination.

Data gathered from a well-designed and -executed environmental monitoring (EM) program provide critical information for tracking and trending on a routine basis. Accurate and consistent species-level identifications result in more confidence in the control of your environment.

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Limulus polyphemus, known as the Atlantic horseshoe crab, is an ancient mariner with a lineage that dates back 440 million years. As keepers of the environment, we have a responsibility to preserve, protect, and live harmoniously with the animals that share our planet. As a source of critical proteins that detect the presence of endotoxins in products and instruments used by humans, the Atlantic horseshoe crab has long been treasured by the biopharmaceutical industry.

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Frequently Asked Questions (FAQs) about Dialysis Water Testing

What happens if dialysis water is contaminated with endotoxin?

It is important to perform dialysis water testing for endotoxins. If there are certain amounts of endotoxin are introduced into the bloodstream or spinal fluid via a parenteral drug or medical device, fever, septic shock, organ failure, or death can occur.

Are there quality guidelines for dialysis water and endotoxins?

The FDA has issued quality guidelines for dialysis water including dialysis water testing for endotoxins: Quality Assurance Guidelines for Hemodialysis Devices.

How do you test dialysis water for endotoxins?

There are several methods to test for endotoxins when dialysis water testing. The main methods used for bacterial endotoxin testing (BET) use Limulus amoebocyte lysate (LAL) and are gel-clot, kinetic chromogenic, and kinetic turbidimetric.

Charles River offers LAL reagents and equipment for all of these BET methods as well as our advanced bacterial endotoxin testing solution, Endosafe® Cartridge Technology. Our FDA-licensed cartridge technology uses the chromogenic method and meets our customers’ need for higher sensitivity and faster quantitative results in the LAL assay.

Created to improve and refine our use of LAL, the Endosafe® cartridge technology cuts out a significant amount of the raw material and accessories required for traditional LAL assay methods while reducing time-consuming preparation and technician variability.