Injectable therapeutics and medical devices placed inside the body need to be verifiably free from endotoxins to ensure patient safety. According to current GMP regulations it is required to test parenteral drug products, and in some cases raw materials, for the presence of endotoxins prior to use. At Eurofins BioPharma Product Testing Belgium we can support endotoxin testing of your products according to GMP standards using established pharmacopeial methods.
When to perform bacterial endotoxin testing?
Guidelines advise endotoxin testing at various stages of production, including but not limited to:
- Raw material
- Bulk harvest
- Final Product
Which endotoxin testing methods do we offer?
We offer three endotoxin (LAL) testing methods and use our extensive expertise to ensure each sample is assessed with the most appropriate method:
- Gel-clot method: The gel‑clot assay is the original LAL method and remains widely used for routine endotoxin screening. It delivers a straightforward positive/negative result by forming a firm clot in the presence of endotoxins, making it ideal for simple sample matrices and qualitative release testing.
- Kinetic Chromogenic method: The kinetic chromogenic method measures endotoxin levels by monitoring the rate of color development triggered by an enzymatic reaction. This approach enables precise quantitation across a broad range and offers high sensitivity, making it suitable for sterile products, biologics, and other products requiring accurate quantitative data.
- Turbidimetric method (outsourced within the Eurofins network): The turbidimetric method is used for samples where natural color, opacity, or other components interfere with chromogenic testing. Instead of color formation, it measures changes in turbidity to provide precise quantitative results, making it the preferred option for visually complex or inherently colored sample matrices.
Regulatory Compliance (USP <85>, Ph. Eur. 2.6.14, JP <4.01>)
Ensuring full compliance with global endotoxin testing regulations is essential for the release of pharmaceutical products and medical devices. Eurofins BioPharma Product Testing Belgium performs endotoxin testing in alignment with all major pharmacopeial and regulatory frameworks, ensuring your products meet global regulatory standards.
Why choose Eurofins BioPharma Product Testing Belgium
- Great flexibility. Our focus on small scale projects allows all flexibility you need.
- Single-point-of-contact. With a wide array of services internally available, all communication is centralised.
- Complete service portfolio. Many additional chemical, microbiological and ancillary services performed in GMP certified, WHO prequalified and FDA approved labs.
- Standard and custom solutions. If our standard solutions do not fulfill your requirements, our skilled technicians are able to develop specialized solutions. Please contact us if you want to discuss your needs.
If you want to discuss your project or request a quotation, feel free to contact us.
