This dosage is sufficient to guarantee a sterility assurance level of 10 -6.īovine Spongiform Encephalopathy-Transmissible Spongiform Encephalopathy The dose range necessary for the stated sterility assurance level is continuously audited through quarterly bio-burden and sterility validation studies performed according to the ANSI/AAMI/ISO 11137 standard by an independent laboratory. Labcon products are sterilized by radiation sterilization within a dose range of 12-35 kGy. Heavy metals have been tested for using the prescribed USP method and confirmed to have levels lower than 1 part per million (1ppm) Extraction fluid is tested for the presence of protease activity by examining test protein degradation in the extraction fluid compared to a negative control and positive control reactions supplemented with 2 nanograms of Proteinase K or Trypsin. Product samples are tested and certified to be free of detectable Protease. PCR reactions using extraction fluid must show no PCR- amplified product compared to a positive control containing one picogram of human genomic DNA for the product to be certified as DNA-free. To confirm the freedom from DNA amplification products are examined by Agarose gel electrophoresis with appropriate positive and negative controls. The relative light units result must indicate less than 2 X 10-12 mg/µl of ATP for the product to be certified as ATP free.

Luminescence data is compared to results generated by ATP-free surfaces and surfaces with known amounts of ATP as a positive control. Product sample surfaces are tested for the presence of adenosine triphosphate (ATP) using a controlled bioluminescence reaction to detect contamination. Extraction fluid samples must show no degradation of the nucleic acids by the extraction fluid has occurred for the product to be certified as RNase-free and DNase-free Results are visualized on an agarose gel with appropriate positive and negative controls. Product samples are exposed to nuclease-free water and the resulting extraction fluid is tested for nuclease activity on commercially available 7.5 kb Poly(A) tailed RNA (1µg) and HindIII-digested DNA (1µg) with a one hour 37☌ incubation in appropriate buffers. All products tested must display less than 0.05 EU/ml to be certified free of endotoxin. Product samples are exposed to endotoxin-free water and the resulting extraction fluid is tested for contamination using the kinetic turbidimetric Limulus Amoebocyte Lysate (LAL) assay protocol and USP guidelines.

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