Accredited Endotoxin Testing You Can Rely On
Fast, accurate and fully compliant testing. Whether you need support with routine batch analysis, method validation or complex low endotoxin recovery.
Find the right support for your endotoxin testing needs
Different organisations require different levels of support. Whether you are implementing endotoxin testing for the first time, working within a defined budget or requiring accredited results for release, our service adapts to your regulatory and operational needs.
New to Endotoxin Testing?
If endotoxin testing is new to your organisation, we guide you through the process clearly and efficiently. From defining limits to understanding sample requirements, we ensure you meet regulatory expectations without unnecessary complexity.
Accredited Test Results Required?
When inspection readiness and documented traceability are essential, we provide UKAS-accredited endotoxin testing with structured reporting suitable for regulated pharmaceutical and biotech environments.
Limited Product or Budget?
For early-stage companies and low-volume manufacturers, outsourcing provides compliant testing without capital investment. Our service supports small batch sizes and development-stage products with transparent turnaround options.
Need Rapid Turnaround Testing?
Where timelines are critical, we offer defined turnaround options to support batch release and production continuity. Early technical review helps prevent delays caused by incomplete documentation or unsuitable samples.
Our Endotoxin Testing Services
Our laboratory operates under UKAS accreditation (No. 23137) and ISO 9001 certification, delivering validated, traceable and inspection-ready data.
-
Batch release testing
Raw materials and intermediates
Finished products
Purified water and dialysis fluids
You receive structured reporting, defined turnaround timelines and technical follow-up where required.
-
Product-specific validation
Interference testing
Pharmacopoeial compliance alignment
Bridging support for internal transfer
Designed for new products, reformulations and challenging matrices.
-
Structured recovery investigations
Controlled spiking studies
Data interpretation support
Regulatory-aligned reporting
Supporting biologics and complex formulations.
-
Investigation of unexpected inhibition or enhancement
Support for out-of-specification results
Risk-based discussion of next steps
Why Partner with CMD?
Working collaboratively with FUJIFILM Wako Chemicals U.S.A. Corporation, CMD provides endotoxin testing services from our state-of-the-art facilities in Cardiff, UK. The laboratory is as a UKAS accredited testing facility No. 23137, operating under an ISO 9001 Quality Management System certified by BSI under certificate number FS749484.
Using the FUJIFILM Wako PYROSTAR™ line of endotoxin-specific LAL reagents, CMD offers routine testing of liquid pharmaceutical products, endotoxin test method development & validation for new products, as well as low endotoxin recovery studies for more complex products including biopharmaceuticals.
Whether you're scaling internal capacity, validating a new product, or resolving interference issues, we deliver timely, precise, and compliant results tailored to your needs.
What We Test
Our facility supports a wide range of sample types, including:
Injectables and infusions
Biologics and biosimilars
Formulations with nanoparticles or adjuvants
Dialysis fluids and medical device rinsates
A Flexible Partner to Support Your Goals
CMD’s testing service is designed to scale with you, from preclinical development to commercial release.
Need help choosing the right approach?
We’ll help define a testing plan that fits your regulatory path, product type and internal capabilities.