Azbil BioVigilant, Inc. (www.biovigilant.com), inventors of Instantaneous Microbial Detection™, announced today that Leiter Rx, one of the country’s foremost compounding pharmacies, will utilize Azbil BioVigilant’s IMD-A® 300-series systems for select cleanroom applications benefiting from real-time microbial air monitoring.
Leiter Rx, established in 1926, has built a reputation in quality process innovation fundamental to reducing risk of product contamination. Charles Leiter, recognized as one of the leading ophthalmic pharmacists in the country, said, “We have never been afraid to invest in technology that will improve our operations. Azbil BioVigilant’s IMD-A system will be used to continuously monitor our cleanroom during syringe filling operations, which will reduce the potential risk of product contamination. We also will utilize the system to promote the best aseptic techniques among our staff. It is a very versatile piece of equipment that keeps us on the cutting edge of quality process advancements.”
When told of the decision, Aric Meares, CEO of Azbil BioVigilant, stated that this was another important milestone for the company. “Pharmaceutical compounding is an area of need where instantaneous microbial detection delivers great benefit. It is gratifying to see Leiter Rx among the first in compounding to utilize our technology platform across their cleanroom area.” He added, “The Food and Drug Administration is actively encouraging drug makers to deploy advanced technologies such as the IMD-A system to realize both quality and drug delivery benefits.”
BioVigilant’s IMD-A 300 and IMD-A 350 systems can detect immediately the presence of bacteria in the aseptic manufacturing process, and as a result, greatly accelerate the quality assurance processes for drug batch release.
About Azbil BioVigilant
With headquarters in Tucson, Ariz., Azbil BioVigilant invented instantaneous microbial detection technology to address environmental monitoring needs in the pharmaceutical, biotechnology, healthcare and environmental applications. Azbil BioVigilant’s IMD systems detect - instantaneously and in real-time - particle count, size and biological status. Unlike other rapid microbial methods, Azbil BioVigilant’s optically based systems require no staining, no reagents, no waiting period and little human intervention. The company holds 20 patents, with an additional 37 applications pending. BioVigilant’s parent company is Azbil Corporation of the azbil Group, part of the TOPIX Mid400 traded on the Tokyo Stock Exchange. For more information, go to www.biovigilant.com.
Leiter’s Pharmacy was established in 1926 in Pismo Beach, Calif., by Harry Leiter. It moved to the San Jose area in 1952, and today offers a complete retail pharmacy and state-of-the-art compounding lab featuring a Class 1000 ISO-6 cleanroom, designed and built to adhere to JCAHO rules and regulations, and is compliant to USP797. Among Leiter’s clients are hospitals, ambulatory surgery centers and several pharmaceutical manufacturers, which Leiter has assisted with drug studies, FDA approvals, and Phase 2 and 3 clinical trials. For more information, go to: http://www.leiterrx.com.
IMD-A®, BioVigilant®, the BioVigilant logo and the term Instantaneous Microbial Detection™ are the trademarks or registered trademarks of BioVigilant Systems, Inc. in the United States and/or other countries. Other names or brands may be the property of others.Business Wire
Last updated on: 08/10/2012