Tego, a leading provider of smart asset solutions based in Waltham, MA, US, has produced an automated, touchless, digital solution for environmental monitoring within FDA-regulated pharmaceutical manufacturing facilities.
Tego’s Asset Intelligence Platform makes businesses smarter by embedding digital information in assets and components for the life sciences, healthcare, aerospace and manufacturing industries. Insights about assets’ lifecycle history, regulatory compliance and integrity can help to drive operational excellence and new revenue models.
Built on this platform, the latest solution applies advances in Industrial Internet of Things (IIoT) technology to precisely track and verify contaminant exposure on product, material or equipment used during production of aseptic pharmaceuticals.
The solution ensures that data is 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.
“Tego’s approach to progressive data on assets is gaining attention from pharmaceutical manufacturers because it helps minimise 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.
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.
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.
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.
The digital environmental monitoring solution was born out of Tego’s work 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.