BioVigilant Systems has launched next-generation IMD-A family of rapid biologic detection systems for real-time environmental air monitoring in pharmaceutical manufacturing environments.
BioVigilant claims its IMD-A 300 and IMD-A 350 systems can detect immediately the presence of bacteria in the drug manufacturing process, in contrast to traditional growth methods.
Based on the principles of Mie Scattering and the intrinsic fluorescence of microorganisms, the IMD-A 300/350 systems utilize laser light to simultaneously distinguish inert from biologic particles, on a single particle basis.
In addition, IMD-A systems can be used to continuously monitor the environment as opposed to traditional methods that are used periodically for spot checks.
The IMD-A 300 samples 1.15 liters of air per minute while IMD-A 350 samples 28.3 liters per minute.
Inert and biologic particles are grouped into one of six bins from 0.5 microns to greater than 10 microns as displayed in PharmaMaster, the systems’ 21CFR Part-11 compliant software.
The software offers different levels of functionality based on user need and authority, and allows for a library of profiles to be created, each with discrete alert and action levels to address a range of applications and manufacturing process environments.
Both visual and audible prompts warn the operator when an alert or action limit has been reached, with a video feed from an optional Webcam available to assist with root-cause analysis when needed.