The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
Sample representativeness and quantity determination for test articles have been discussed in my previous posts. Continuing on the topic of what to consider when performing biological testing, this post will cover the extraction conditions to be applied for testing. Extraction...
In my previous blog post I discussed sample representativeness and provided recommendations on how test articles should be prepared, outlining details that may be overlooked in the process. With various considerations that need to be accounted for, it is difficult...
When designing a biological test plan for a device, one may easily overlook details on the types of samples to be used and how they should be tested. ISO 10993-12 states that biological testing should be performed on final, finished...
