Product Testing

CBL typically performs the following tests on products:

• Identification testing on client supplied raw materials (API and excipients).
• In-process testing sufficient to ensure bulk formulation is done correctly and other standard in process tests (pH, density, bioburden, etc. as appropriate).
• Finished product testing as requested by the client, but sterility at a minimum is done at CBL.

The Analytical Services Department (QC) can perform the following tests:

The Microbiology Department can perform the following tests:

• Enhancement & Inhibition
• Endotoxin
• Bioburden Method Qualification
• Bioburden
• Bacteriostasis/Fungistasis
• Bulk Sterility
• Final Product Sterility
• ELISA

Stability Testing

CBL has validated chambers for ICH stability temperatures in place and operating. Upon request, CBL will generate stability testing protocols and schedules which are rigorously followed. CBL will also quote individual tests requested by clients to support stability programs run by clients in their facilities.