Zentek completes shelf-life efficacy testing for ZenGUARD Enhanced Air Filters

Zentek (ZTEK) announces that shelf-life efficacy testing has been completed on aged ZenGUARD Enhanced Air Filters, which is required for medical device compliance. On November 27, 2024, Zentek announced that the Company will manufacture and sell its ZenGUARD Enhanced Air Filters as a Class I medical device under its medical device establishment licence. The change in regulatory pathway required the completion of “End Product Stability and Performance Testing.” These tests are essential for medical devices as products must demonstrate consistent performance and safety of the device until a subsequent expiry date. The expiry date must be clearly identified on the label of all medical devices. ZenGUARD Enhanced Air Filters were real-time aged for 20 months and then submitted to LMS Technologies for VFE and shedding testing. The VFE was tested for the aged filters to determine the reduction in bioaerosols that is achieved under normal operating conditions with an airflow of 500 ft/min and was consistent with ASHRAE 241 Section L standards. The recently completed testing of the 20-month aged filters measured an initial VFE of 38.1% which was similar to the original test performance of 37.7%. Likewise, a shedding test on the 20-month-aged filters was completed using a laser particle counter to determine the number and size of particles in the airstream under normal operating conditions. The shedding test demonstrated that the coating maintains excellent adhesion to the substrate over 20 months as the number of particles counted in the airstream after passing through the filter were within statistical deviation with the background particle counts measured with no filter present in the test chamber. Based on the VFE and shedding test results, ZenGUARD Enhanced Air Filters will be labelled with a 20-month expiry from the date of manufacture.