Endotoxin Detection Expertise
Our Endotoxin Testing Service combines Lonza’s expertise with full service reporting, offering both research and pharmaceutical customers’ routine and customized endotoxin testing.
Lonza’s Endotoxin Detection Testing laboratories are located in our cGMP-certified manufacturing plants in Walkersville, MD USA and in Verviers, Belgium. Our Endotoxin Testing Service is designed for customers from the pharmaceutical industry, medical device companies, research and environmental laboratories.
Pharmaceutical-grade testing is offered both in the U.S. and Europe. This service includes all of the validation steps required during a product validation program and requested by regulatory authorities to be compliant with the current harmonized Bacterial Endotoxins Test (BET) as defined in the U.S. Pharmacopeia (USP) and European Pharmacopeia (EP). For the medical device industry, our service complies with the USP Monograph General Chapter, Citation <161> Transfusion and Infusion Assemblies and Similar Medical Devices.
Customers can select their method of choice for endotoxin testing: gel clot, kinetic chromogenic, kinetic turbidimetric and PyroGene™ recombinant Factor C assays.
Unless specified otherwise, testing will be performed using the Kinetic-QCL™ Kinetic Chromogenic LAL assay. All invoices are sent after testing is complete.
Pre-paid, Mail-in Anytime Testing Service
Available in Europe, the Endotoxin Testing Service offers a low cost, mail-in anytime service for users not requiring testing according to pharmaceutical or medical device regulations.
This type of endotoxin testing is suitable for a wide range of non-standard tests such as:
- Samples from cell culture materials
- Samples of DNA plasmids
- Water samples from autoclaves or dialysis machines
- Dialysis water or fluids
- Research samples
Samples received using this service will be tested at the required dilutions indicated in the Pre-paid Endotoxin Testing Service diagram.
To utilize the Pre-paid Service, simply order one of more of the rapid endotest packs, place your sample in the sample containers and mail the pre-addressed envelope back to Lonza.
When ordering the catalog numbers for the Pre-paid Service, 91-101 for example, the pre-paid endotest packs are included to ship the samples to the Endotoxin Testing Services. When you have a requirement for an endotoxin test, simply mail in your samples. Samples will be tested and results sent to the customer within 5 days of receipt.
Please contact Lonza prior to sending samples for testing. To place an order for the Testing Services please contact Verviers customer service or send an email to firstname.lastname@example.org.
The use of appropriate sample containers such as Lonza Catalog No. 80-507 (depyrogenated glass sample container) is strongly recommended, however, alternative containers are acceptable. It is the customer’s responsibility to validate the container for storage prior to sending samples to avoid any endotoxin or leachable contamination of the sample.