RAD STERILIZATION VALIDATION

QIAGEN's radiation sterilization validation service helps manufacturers and laboratories confirm that enzymes, buffers, reagents, and diagnostic components maintain functional integrity after exposure to gamma or electron beam sterilization. Validation protocols assess bioactivity retention, protein structure stability, and packaging compatibility across a dose range of 10 to 50 kGy, covering the minimum and maximum doses specified by ISO 11137 for terminal sterilization of healthcare products.

The service package includes pre-irradiation baseline characterization, dosimetric mapping using calibrated alanine or ceric-cerous dosimeters, and post-irradiation functional assays such as enzymatic activity testing, PCR amplification efficiency, and nucleic acid binding capacity. Each validation run is documented in a traceable report that supports regulatory submissions under ISO 13485, FDA 21 CFR Part 820, and EU MDR requirements.

Samples are shipped in temperature-controlled packaging and should be stored at room temperature prior to irradiation. Turnaround times range from four to six weeks, depending on the number of dose levels and replicate conditions required by the customer's sterilization validation plan.