The FDA requires manufacturers operating under Current Good Manufacturing Practices (CGMP) to certify that every batch of drug, vaccine, or biologic be produced in a high quality controlled environment.
Digital Environmental Monitoring (EM) removes human factors and provides significant process improvement opportunities. These digital, data-driven solutions must survive sterilization. However, digital EM with sterilization-proof technology allows CGMP manufacturers to write data directly onto a) products and materials that must be tracked and verified before, during, and post-production and b) products and materials that monitor sterility. More importantly, digitized environmental monitorying makes data available via touchless, sightless procedures.
The digital traceability and visibility provides a full GMP compliance solution as well as an early warning system.
Tego’s environmental monitoring solution provides increased assurance of sterility for aseptically produced pharma and medical products.