Drug & Medical Device Testing Product 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 Test for Interfering Factors of End Product Tests and Release Testing). Testing for endotoxins is also frequent- ly performed to assess raw materials, in-process materi- als, vendors, as well as for 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’s quality departments in identifying endotoxin sources, and troubleshooting product and production issues. CTS can help with integrating endo- toxin 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). Identi- fying 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 facilitate 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.
Test Types • Preliminary Test - This test is used to quantify the amount of endotoxin or glucan present in a test sample using a known set of conditions. A series of dilutions are made in order to find a valid testing dilution which can be used to calculate the endotoxin or glucan concentration in a sample. • USP/EP Test for Interfering Factors (Validation) - This test is used to demonstrate that the product does not interfere with the BET assay. This test is per- formed at a dilution not exceeding the Maximum Valid Dilution (MVD) for that product. The MVD is a func- tion of the endotoxin limit for the product. Test for Interfering Factors is required for all finished products that are parenteral or intrathecal and for non-pyro- genic medical devices. The procedure is also used to demonstrate that the test conditions are valid when used to test raw or in-process materials. • Release Test - This test is used to release finished products once the Test for Interfering Factors has been performed. The test is run at the same dilution used in the Test for Interfering Factors. The Release Test is also used to release raw materials, in-process materials, and other non-finished goods.
The Test for Interfering Factors of End-Product Tests
Production lots of the final product should be subject to the Test for Interfering Factors before the test may be used to release final product. The assay is also used in QC programs to accept raw materials into production. Testing can be performed in accordance with USP, EP, and/or JP, depending on the specifications of the client.
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