The purpose of this study is to establish a material library and discuss its potential application to the development and lifecycle management of a continuous manufacturing process for solid dosage forms.
Particularly, this study addresses the importance of selecting process-relevant testing… Read More...
Following the intro- duction of the continuous Glatt Modcos system, Glatt is working together with partner Driam to close a gap in the production process by incorporating continuous tablet coating. Like Modcos, the continuous Driaconti-T system enables complete traceability of every tablet as well… Read More...
Data provided by in situ sensors is always affected by some level of impreciseness as well as uncertainty in the measurements due to process operation disturbance or material property variance.
In-process data precision and reliability should be considered when implementing active product quality… Read More...
Guidance for Industry - DRAFT GUIDANCE - pdf download at the end of the text.
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice… Read More...
A programme of work on continuous tablet manufacturing was completed as part of a UK based collaborative research project (REMEDIES: RE-configuring MEDIcines End-to-end Supply) to evaluate the operating space of the continuous platform with respect to material properties. Loss-in-weight (LIW)… Read More...
Continuous powder feeding is a critical step in continuous manufacturing of solid dosage forms, as this unit operation should ensure the mass flow consistency at the desired powder feed rate to guarantee the process throughput and final product consistency. In this study, twin-screw feeding of a… Read More...
The pressure to innovate faster than their competitors has drug formulators exploring new ways to optimise manufacturing processes
Article in manufacturingchemist.com
Continuous manufacturing, for example, has evolved at a relatively fast pace, leaving drug manufacturers feeling equally challenged… Read More...
This study focuses on the behavior of powder particles in a rotary tablet press with special focus on the feed frame system. To obtain a better knowledge of the continuous manufacturing of tablets, the experimental setup was carried out with a production scale rotary tablet press. The behavior of… Read More...
This study focussed on investigating the coupling of continuous manufacturing of drug substance and continuous manufacture of drug product. An important step in such an integrated end-to-end continuous manufacturing was envisioned by dosing the API as suspension into a twin-screw wet granulation… Read More...