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.
STAT Testing Available
For customers who may need faster turn-around times, Lonza offers an expedited testing service for preliminary screening, endotoxin determination, and the Endotoxin Challenge Vial™ test. Our STAT service delivers preliminary (unaudited) results in 4 days or less. STAT requests require prior approval from Lonza’s Endotoxin Testing Services.
Please contact Lonza prior to sending samples for testing. To place an order with Endotoxin Testing Services, please contact U.S. 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.
Product Preliminary Screening
Preliminary Screening, Catalog No. 80-500
A feasibility study performed on all new products submitted to the Endotoxin Testing Service prior to product validation testing. Preliminary screening determines the most adequate concentration of the test sample that would minimize interference with an endotoxin detection assay.
Note: preliminary screening must always be performed prior to product validation testing.
Product Validation Inhibition/Enhancement, Catalog No. 80-501
Validation on one batch or 80-502 Validation on three batches.
Inhibition and enhancement testing performed according to USP/EP BET guidelines, which can be used to validate a final product for routine batch testing and release with an endotoxin detection assay.
Endotoxin Determination, Catalog No. 80-503
Endotoxin determination of a single sample.
Cat. No. 80-509: Additional samples of same shipment under 80-503. Routine or final product release test to determine endotoxin content in a test sample.
Oven Validation Tests
Oven Validation, Catalog No. 80-535
Endotoxin analysis of vials after oven depyrogenation run. Prepaid test for validation of oven depyrogenation cycles using an Endotoxin Challenge Vial™ (ECV).
Exclusion of β-D Glucan Activity
Exclusion of β-D Glucan Activity Test, Catalog No. 80-514
This tests uses a glucan blocker with the test sample to determine whether positive endotoxin results with an LAL test are valid or due to the presence of glucans.
Sample Container Study
Sample Container Study, Catalog No. 80-544
How does the test work?
A minimum of 15 samples will be analyzed using a kinetic endotoxin test method (kinetic chromogenic or kinetic turbidimetric) at each time point after spiking a high and low level of endotoxin into the containers. All spikes are created with Reference Standard Endotoxin (RSE).
Sample containers are tested at two time points: T0 simulates the start of sample hold time and T1 simulates the end of the hold time. Specific hold times and storage temperatures are required as part of the sample submission process. A minimum of 15 containers of one type are required to complete the study.
Certain other variables of the container study can be customized to fit your specific needs:
- Number of containers and lots
- Fill volume
- Storage temperatue
- Hold time
How to Submit Samples
Contact your local Lonza Sales Representative or Customer Service Department for more information about pricing, and to coordinate shipment of your sample containers to our testing laboratory in Walkersville, Maryland, USA.
Complete the Container Study Sample Submission Form supplied by the representative and return to Lonza for proper delivery and sample tracking.