The pharmaceutical industry has historically taken a cautious approach to new advancements. But now, it is embracing the possibilities of continuous manufacturing technologies. While traditional batch based processes are still the industry standard, there are several products on the market that have utilized continuous manufacturing practices in their development. Over the last decade, this approach has generated a considerable amount of attention. To take a deeper look at the issues...
This study presents a framework for process and product development on a continuous direct compression manufacturing platform. A challenging sustained release formulation with high content of a poorly flowing low density drug was selected. Two HPMC grades were evaluated as matrix former: standard Methocel CR and directly compressible Methocel DC2. The feeding behavior of each formulation component was investigated by deriving feed factor profiles.
In the highly regulated pharmaceutical industry, manufacturers can’t help but wonder what regulatory authorities like the FDA think of emerging technologies. So what do the global authorities have to say about continuous manufacturing?
The paradigm shift in the pharmaceutical industry to continuous manufacturing, which has recently progressed from conceptual demonstration to pilot production, has stimulated the development and application of process systems engineering (PSE) tools for implementing efficient and robust control strategies.
Industry delegates say the US Food and Drug Administration (FDA) is showing increased support for continuous manufacturing, a stance C-SOPS told us is quality control-driven.
Process Analytical Technology, or "PAT" is the term given to analytical instruments developed to measure certain attributes of product within the manufacturing process, eliminating, or substantially minimising the need for sampling for off-line analysis
Abstract The present study summarizes the experimental characterization of a new continuous powder mixer (GCG-70 by Glatt®) using common pharmaceutical ingredients. The powder hold-up and residence time distribution were used to characterize the bulk behavior of the mixer as a function of impeller rotational speed, total throughput (mass flow rate) and blade configuration. The relative standard deviation (RSD), calculated from samples taken at the outlet of the blender, was used to...
With the Glatt MODCOS (Modular Continuous System) process insert, batch versions of the GPCG 2 and GPCG 10 series can be easily converted to continuous fluid bed systems and integrated into a continuous process chain. More Information & Video