Press Room

News / Aug 08, 2022

Approved gas reduction in the EU

News release, 8 August 2022

hovione logo on a brick wall in Cork Site

Last week, in an effort to increase energy security in the European Region and prepare for possible disruptions of gas supplies from Russia, the European Union (EU) member states reached a political agreement on a voluntary reduction of natural gas demand by 15% this winter. To respond to this engagement, each Member State will need to define the measures it will adopt between the 1st of August 2022 and the 31st of March 2023. To reflect the individual situations of Member States, some exceptions are expected, however, at this date details are still unknown. 

 

Although we do not expect the Hovione manufacturing operations to be affected, it is not unreasonable to expect that some of our suppliers of raw and starting materials may be impacted.  We are therefore preparing a risk mitigation plan, which includes strengthening our supply chain to reduce the impact that any disruption may have on our activity. 

 

One option we decided to offer to our customers is to purchase raw materials early and store them closer to our manufacturing site. If you are interested in exploring this option or have questions or alternate proposals, please contact your Account Manager. 

 

As your partner, we are committed to employing our best efforts to mitigate any serious impact that might get in the way of our delivering the products and services requested by our customers.

 

Thank you for your trust and collaboration through these unprecedented challenges. 

 

Patients need us. We are In it for life.

 

 

 

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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  

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