FDA regulation

The Need

21 CFR Part 212 (PET cGMP regulations) call for strict control over production of radio-pharmaceuticals for PET (Positron Emission Tomography).  Quality Control (QC) is the only part of the production process that is not automated and consists of 10-15 tests relying on a complex set of poorly traceable manual procedures, multiple instruments and subjective assessments.  This results in high cost of cGMP compliance, high risk of non-compliance and throughput challenges.

The Solution

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. It eliminates the human factor and leaves no room for missing a process, record, or signature.

The Result

Complete traceability and objectivity that are achieved with Tracer-QC™ maximize cGMP compliance, increase throughput and reduce operating costs.

Learn More about Tracer-QC

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