SteriTEQ™ Sterility Testing System (12-Pack)
SteriTEQ concentrate provides a USP <71> compliant destructive sterility test for canceled or returned sterile products. The SteriTEQ is aseptically introduced in a pharmacy-friendly manner by the compounding operative directly into the end-product to be tested and produces a 100 percent aliquot test. SteriTEQ concentrate can also be used to routinely monitor the sterility of compounder source bags, tubing, and reconstitution pumps and equipment.
End-Product Sterility Test
The entire product and its container become the aliquot sterility test. The SteriTEQ multi-strength Trypticase soy broth is aseptically introduced by the compounding operative directly into the end-product in the amount of 5mL per 100mL of end-product to be tested, thus producing a 100% destructive aliquot test of the subject. The container is then incubated at room temperature (20-25 degrees C) and read periodically for clarity, without the need for an incubator. The SteriTEQ end-product sterility test exceeds the test volume and dilution requirements of USP <71>.