USP <1223> & EP 5.1.6 Validation Testing Of IMD‐A® 300/350 Systems

This fact sheet provides a summary of test parameters and results for BioVigilant’s IMD-A 300 and IMD-A 350 systems based on USP <1223> and EP 5.1.6 validation guidelines. 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 this fact sheet.

In the United States and Europe respectively, the USP <1223> Validation of Alternative Microbiological Methods standard, and EP 5.1.6 Alternative methods for control of microbiological quality standard guide the validation or implementation of alternative microbiological methods such as BioVigilant’s IMD-A systems. Results from testing to these standards are filed as part of BioVigilant’s Drug Master File (DMF) submissions to the U.S. FDA, which supplement the testing drug makers may perform to validate IMD-A systems for use in their manufacturing areas.