Press Room

Webinar - Heavy Metals determination by UPLC

Start
Thursday, January 29, 2015 - 14:00
End
Thursday, January 29, 2015 - 15:00

Speakers

António Ramos

Analytical Development Group Leader 

Lúcia Volta e Sousa

PhD Student / Analytical Chemist

 

Elemental impurities analysis has a great importance within pharmaceutical realm due to its impact on the quality, safety and efficacy of drug product and substances. These impurities can include catalysts and environmental contaminants that may be present in drug substances, excipients or drug product. For that reason, it is necessary to have a rigid control, during the manufacturing process in order to assure that the final product is within the specification limits described in the USP chapter and recently approved ICH Q3D guideline. There are two procedures acknowledge by USP that can be used to analyze and control these materials, as ICP-MS and ICP-AES. These techniques are expensive and most of the times are not available in every manufacturing sites. According to USP acceptable alternative procedures that meet validation requirements can be used. An alternative Microwave / UPLC / UV-VIS provides a powerful, advantageous and fast solution for heavy metals determination with improvements in terms of time and costs. The breakthrough is the use of microwave based digestion to obtain a universal method that can be applied to any organic matrix. The use of a Quality by Design approach will allow for a better understanding of the method design space and a more effective method development.

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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