Determination of endotoxin levels

Analysis of endotoxin levels is a crucial part of quality control in biotech, medtech, and pharmaceutical industries. An accurate and precise analysis can help reduce the risk of adverse effects and ensure high quality and safety of biological products.

This service is also relevant in: Biotechnology, Food

Service details

Service
Determination of endotoxin levels in samples
Delivery level
Accredited
Price

Contact us for price information. Please find contact information below.

Preparations

Both solid and liquid samples can be prepared and analysed.

Request for quote

CAPTCHA
By submitting the form, RISE will process your personal data.

Jessica Wahlgren

Forskare
+46 10 722 32 97 Read more about Jessica

Contact Jessica

CAPTCHA

* Mandatory 

By submitting the form, RISE will process your personal data.

Purpose

Endotoxins are components of the outer cell membranes in gram-negative bacteria and when released, can cause serious and sometimes deadly inflammatory reactions in humans and animals. Therefore, it is important to ensure that medical devices, biological and pharmaceutical products and materials are free from endotoxins before use.

Method

At RISE, endotoxin levels are analyzed using a kinetic chromogenic Limulus amebocyte lysate (LAL) method according to Eur.Ph.2.6.14 (method D). The LAL test is based on the coagulation reaction of amebocytes from horseshoe crabs, which react with endotoxins. The test is sensitive and specific for endotoxins and can detect very small amounts.

For the analysis, the Endosafe® LAL-cartridge system from Charles River Laboratories, with FDA-licensed cartridges and the Endosafe® Nexgen PTS™ reader is used. The detection limit for the analysis is 0.005 EU/mL.

We can analyze both liquid solutions and solid materials, e.g. medical devices. Solid materials are extracted according to US Pharmacopoeia chapter 161.

Deliveries

The results are presented in a report with an overview of the detected levels in each sample.

Related

Drug development / Expertise

Vaccine

Vaccine development is a prioritised area to increase global health. At RISE, we offer infrastructure and broad expertise in the field of vaccines. We can guide you through the entire process, from research and regulatory requirements to the finished vaccine.
Service

Biomechanical tissue analysis

Knowledge about a material´s mechanical properties and behaviour when subjected to loading is needed in order to demonstrate the applicability of the materials for a specific task.
Service

ISO 17664 Validating Instruction for Users - cleaning and disinfection

For reusable medical devices, there must be a validated Instruction for Users (IFU) for cleaning and disinfection. We assist in creating a functional instruction according to both ISO 17664-1 and ISO 17664-2 and validate that the products are properly cleaned and disinfected.
Service

ISO 17665 Validation of Sterilization Instructions

In the Instruction for Users (IFU), supplied with reusable medical devices or medical devices to be sterilized by the user, there should be a validated instruction for sterilization. We can validate the sterilization of your product, according to EN ISO 17665:2024.