21 CFR Part 212 (cGMP) regulations call for strict control over production of radio-pharmaceuticals for PET (Positron Emission Tomography). Quality Control (QC) is the only part of production process that is not automated and consists of 12 tests relying on a complex set of poorly traceable manual procedures and subjective assessments. This results in high cost of GMP compliance, high risk of non-compliance and throughput challenges.
Trace-Ability has enabled complete automation of radio-pharmaceutical QC testing on a very simple platform based on proven hardware and software. Tracer-QC consumables eliminate any need for cleaning and all cross-contamination risks. The user adds sample, starts the process and walks away with a complete QC report generated automatically. Of all automated solutions that have been contemplated to date Tracer-QC is the simplest, easiest to use and most compact.
Complete traceability and objectivity that are achieved with Tracer-QC™ maximize cGMP compliance, increase throughput and reduce operating costs.
Learn More about Tracer-QC
Contact Trace-Ability for customer or investor inquiries.