Tego’s Asset Intelligence Approach Survives Gamma Sterilization, Reduces Risk of Contamination and Streamlines Compliance Processes for CGMP Pharmaceutical Facilities
WALTHAM, MA, April 13, 2017 – Tego, Inc., a leading provider of smart asset solutions to produce meaningful operational intelligence from any asset, anywhere, today announced availability of an automated, touchless, digital solution for environmental monitoring within FDA-regulated pharmaceutical manufacturing facilities. The solution is built on the company’s award-winning Asset Intelligence Platform and leverages advances in Industrial Internet of Things (IIoT) technology to enable precise tracking and verification of contaminant exposure on product, material or equipment used during production of aseptic pharmaceuticals.
“Tego’s approach to progressive data on assets is gaining attention from pharmaceutical manufacturers because it helps minimize the potential for contamination and batch loss, and provides more complete traceability and visibility data as required by the FDA,” said Timothy Butler, founder and CEO of Tego, Inc. “Tego’s core platform turns otherwise inanimate things into living, breathing sources of critical business information, and it is exciting to see indispensable industries like pharmaceuticals recognize the value of putting dynamic data on their assets.”
Pharmaceutical manufacturers who perform aseptic processing are required to deliver meaningful information about the quality of the manufacturing environment during production. They must demonstrate to regulators that proper controls are in place, quickly discover problems or put themselves at risk of significant financial loss (one lost batch can cost $500,000 or more), and always have the right data at hand to support root cause analysis procedures.
When data gets stored directly on environmental monitoring components, processes become automated and touchless so that manufacturers greatly reduce the possibility of contamination, and limit the potential for costly wasted batches. Staff are able to receive digital validation about the status of monitoring componentry, and instantly update a component’s documentation as it changes across multiple prescribed points during CGMP manufacturing. All types of environmental monitoring – for airborne particulates, active viable air, passive viable air, surfaces, water, and personnel – benefit from this aseptic-proof, digital solution.
Tego’s digital environmental monitoring solution is a direct transference of the company’s heritage in the aerospace industry, where putting data on critical airplane parts and components has dramatically improved decision-making in the field, supported far more accurate reporting, extended products’ lifecycles, and produced significant cost savings.
CGMP manufacturers who want to explore how asset intelligence can both help with compliance to zero contaminant mandates, and eliminate burdensome post-sterilization labeling processes, can visit https://tegoinc.com/contact/ to set up a demo, or contact Tego at (781) 547-5680.
About Tego
Tego powers assets with intelligence. Tego’s Asset Intelligence Platform makes businesses smarter by embedding digital information in assets and components for the aerospace, life sciences, healthcare and manufacturing industries. Insights about assets’ lifecycle history, regulatory compliance and integrity drive operational excellence and new revenue models. Smart asset data is available for the right people and systems, including IoT, EAM, ERP, and Analytics applications.
Tego is an architect and co-author of the aerospace Spec 2000 Ch9-5, has 30 granted patents, serves dozens of global customers including Honeywell, Parker Aerospace, and B/E Aerospace, and is a healthcare leader with the Industrial Internet Consortium (IIC).
