This article presents guided wave radar level measurement as an acceptable, less expensive alternate to load cell systems. By David Ladoski and Dan Klees
In many pharmaceutical processes, what works in the lab doesn’t always scale-up seamlessly into production; this is true in conical milling. Larger batches, different process conditions, and varying material characteristics can all create unforeseen problems that ultimately impact performance. Despite this, lab and pilot milling can still be a great indicator of scale-up output, and certain steps can be taken to maximize the likelihood of successful production. This white paper will aim to help you scale-up with minimum disruption or deviation. While there is no silver bullet, identifying potential pitfalls while understanding best practice can at least provide a logical road map for achieving milling success.
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.
To secure their position in an increasingly fierce market environment, pharmaceutical companies keep pushing the boundaries of their production capacities. Reaching that goal not only requires them to increase batch sizes. They must also optimize their existing manufacturing processes with state-of-the-art equipment and software systems while ensuring maximum safety for both products and operators. This is exactly what Bosch Packaging Technology offers its customers with tailor-made capsule filling lines backed by decades of experience in capsule filling processes and technology.
“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.
The Biopharmaceutics Classification System (BCS), developed by the U.S. Food and Drug Administration to simplify and accelerate the drug development process, helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing. The objective of the BCS system is to predict in vivo performance of drugs from in vitro measurements of solubility and permeability. The system has evolved to classify low-soluble drugs according to their permeability (BCS Class II or IV). A compound’s classification (I through IV) is indicative of its potential bioavailability.
In order to keep up with fast developing technical standards, pharmaceutical manufacturers face the question whether investing in new equipment is the most profitable solution.