Press Room

XXVII National Congress of the Portuguese Chemistry Society

Start
Wednesday, July 14, 2021 - 09:00
End
Friday, July 16, 2021 - 18:00
XXVII National Congress of the Portuguese Chemistry Society | Hovione

Hovione sponsors and participates at the XXVII National Congress of the Portuguese Chemistry Society with two scientific presentations:

 

Presentation 1

14 July, 16h10
Calorimetry of NBS in DMF: unstable or understudied?

Speaker: Elsa Gonçalves – Process Safety Scientist, Process Chemistry Development

Abstract: The presentation portrays the contribution of the Process Safety team to ensure the safety and improvement of the chemical processes being conducted at the Hovione plant. Elsa will present a recent case study in which the Process safety input was crucial for the optimization of the process, reducing its hazardous and increasing its efficiency.

 

Presentation 2

15 July, 16h30
Low-field Benchtop NMR for solvent swap analysis

 

Speaker: Marta Andrade – Scientist, Process Chemistry Development

Abstract: The presentation will show the results of an extensive study using a benchtop low-field NMR spectrometer (1H-NMR, 43 MHz) to quantify solvents in 20 binary systems that are commonly used for swap process under API manufacture processes. The exciting results open the way to use benchtop low-field NMR as PAT tool for real time solvent swap in-process control, saving time and resources.

 

Also in the Press Room

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Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

Article

Continuous Tableting and the Road to Global Adoption

Mar 04, 2024