Systems should be analyzed not only for their basic ability to contain the powders of interest, but also for how efficiently they integrate into the production process. For instance, will the system help to eliminate productivity bottlenecks, decrease material waste and the cost of raw materials, and simplify the changeover of the line to new products?
For many decades the only practical metric of airborne microbial contamination has been the colony forming unit (cfu). Adapting growth-based approaches for monitoring modern aseptic manufacturing processes has sometimes proven difficult. Although microbiologists have bemoaned the limitations of measuring only cfu, no alternative metric or technique has yet been adopted. In this article we will review one such alternative microbiological method, commonly called laser induced fluorescence (LIF).
After multiple successful facility projects across the world, Extract Technology were approached by a major Pharmaceutical Company and given the challenge to update the older generation of containment equipment from 1990’s technology to the advanced technology available today.
“Closed system filling” is a new set of processing controls appropriate for a sterile filling process that eliminates potential microbiological contamination from environmental and operator sources through the use of closed systems. This is an automated sterile connector technology by which presterilized closed containers are filled through an engineered and controlled passage enabling the filled product, the internal container and the closure system surfaces to avoid exposure to the background environment.