Wednesday, 14 August 2013

BioVigilant’s IMD-A 300 and IMD-A 350 systems

The IMD-A series of systems is designed to continuously monitor air and instantaneously detect the presence of both single and agglomerated microbes in real time. Testing was performed to demonstrate that the IMD-A systems are equivalent to, if not better than, the compendial microbiological method as per USP <1223> and EP 5.1.6 guidelines. Comparison of the IMD-A systems to the compendial method was gauged through the side-by-side testing of four IMD-A systems, two of each model, and three air samplers common to the pharmaceutical manufacturing environment: the SAS Super 100, MAS 100NT, and SMA. In order to stringently assess all systems, a highly homogenous, state-of-the-art aerosol test chamber was employed in order to ensure that these systems were sampling the same aerosol environment concurrently throughout the extensive test trials.

BioVigilant has maintained close communications with the FDA regarding the test plan, statistics utilized, and the subsequent results obtained, now summarized in a fact sheet (click here for more details).


Posted by Tim Sandle