Pyrogen Testing by LAL methods
Testing for endotoxin is performed at many steps in the manufacture of drugs and medical devices
- Endotoxin testing is required for the release of finished product.
- Testing for endotoxins is performed to assess raw materials, in-process materials, vendors, as well as projects and components in research and development.
- Endotoxin testing is often a component of investigations into product quality issues.
- Typically, three production lots of the final product should be subject to validation (inhibition or enhancement test) before the test may be used.
- Validation testing can be performed in accordance with EP or USP depending on the specifications of the client.
Raw materials testing
- The raw materials test is performed according to a validated method and is used to accept the product.
- Identifying the amount of endotoxin in raw materials helps highlight process modifications that can improve the final product. Matching results from raw materials and final product can yield the contribution of each raw material to the endotoxin content of the final product and document improvements in quality during production.
- Some raw materials have endotoxin limits established and confirmed to determine if a batch can be accepted from a vendor.
- Raw materials testing can be performed in accordance with EP or USP depending on the specifications of the client.
- The release test is performed according to a validated method and is used to release the finished product.
- Release testing can be performed in accordance with EP or USP depending on the specifications of the client.
Implementation of (alternative) methods
- CellMadeTM Laboratories selects (alternative) methods from trusted suppliers.
- The implementation process of a novel compendial method within our laboratory is performed according European Pharmacopoeia 10th edition, 10.6, General Notices, Section 1.1.2 Compliance with the Ph. Eur., January 2022. The method verification report(s) and data are available under the Resources Centre of this website.
- CellMadeTM Laboratories regularly participates in international proficiency tests organized by recognized companies and institutions.
- The results of the proficiency test(s) are available under the Resources Centre of this website.
Below table summarizes the available testing services using LAL.
|LAL0001||BET using kinetic chromogenic LAL||
For use in compliance with EP, USP endotoxin test chapters. Max sensitivity of 0,001 EU/mL. For a broad range of endotoxin tests.
|LAL0002||BET using Recombinant Cascade Reagent (rCR)||
Max sensitivity of 0,005 EU/mL. For a broad range of endotoxin tests.