Drug + Device Testing
Discover ACC’s Services for Product Testing, Raw Materials Testing, Validation of End-Product Tests, and Release Testing
Product Testing
Endotoxin testing is performed at many steps in the manufacture of drugs and medical devices. It is required for the release of the finished product. Testing for endotoxins is also frequently performed to assess raw materials, in-process materials, vendors, projects, and components in research and development. Endotoxin testing is often a vital part of investigations into product quality.
ACC’s Contract Test Services (CTS) lab works with you to perform testing rapidly. It assists customer quality departments in identifying endotoxin sources and troubleshooting product and production issues. CTS can also help integrate endotoxin testing into your facility’s quality system.
Raw Materials Testing
Raw materials can be tested in 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 the final product. The validation assay is also used in QC programs to accept raw materials into production. Validation testing can be performed according to USP, EP, and/or JP, depending on your specifications.
Release Testing
The Release Test is performed according to a validated method and is used to release finished products. The test can also be performed for release of raw/in-process materials. Release testing can be performed according to USP, EP, and/or JP, depending on your specifications.