Drug & Device Testing
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 (see Validation of End Product and Release Testing below). Testing for endotoxins is also frequently 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.
CTS works with clients to perform testing rapidly and assists customer quality departments in identifying endotoxin sources, and troubleshooting product and production issues. CTS can help with integrating endotoxin testing into the quality system at the client’s facility.
Raw Materials Testing
Raw materials can be tested as part of a traditional QC program or Process Analytical Technology (PAT). 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 should have endotoxin limits established and confirmed to determine if a batch can be accepted from a vendor.
Validation of End-Product Tests
Typically, three production lots of the final product should be subject to validation (inhibition or enhancement test) before the test may be used to release final product. The validation assay is also used in QC programs to accept raw materials into production. Validation testing can be performed in accordance with USP, EP, and/or JP, depending on the specifications of the client.
The Release Test is performed according to a validated method and is used to release finished product. The test can also be performed for release of raw/in-process materials. Release testing can be performed in accordance with USP, EP, and/or JP, depending on the specifications of the client.
A Sample Submission form must be completed and accompany each sample sent for testing. Sample Submission forms can be obtained by calling CTS (U.S. office (888) 232–5889 or U.K. office (44) 151-547-7444) or click here to download a PDF of the form.
What To Send:
- Finished products should be sent in their final packages. This is especially important for medical devices.
- MSDS sheets for samples.
- Non-finished products may be shipped in any container that does not adsorb endotoxin or produce compounds that may interfere with the assay. Examples of acceptable containers are glass, polystyrene, and PET plastic.
- Solid samples: A convenient sample weight is 100 mg or more.
- Liquid samples: A convenient sample volume is two milliliters for the turbidimetric and chromogenic assays and four milliliters for the gel-clot assay. If the concentration of the product is known, please state. Depending on the final concentration needed for testing, smaller volumes may be acceptable.
- A completed Sample Submission Form can be downloaded here or by calling the numbers listed on the main CTS page. (More information on this form is listed below.)
- Do NOT send samples that are infectious to humans or are radioactive. Samples from human tissue must be accompanied by a copy of lab results showing that the patient does not have hepatitis or HIV virus.