QbD Process Technologies unique ContinuousPlant® suite of real-time (RT) software and services allows pharmaceutical and biotech manufacturers to deploy advanced continuous manufacturing (CM) processes by integrating in-process Process Analytical Technology (PAT) orchestrations with advanced process control (APC) applications, and material traceability solutions. Our integrated CM solution enables the production of drug products more efficiently, reliably, and of better quality than traditional batch manufacturing methods.
QbD Process Technologies offers a full range of process automation and data management services to assist with the selection, design and implementation of the solution best suited for your continuous manufacturing process.
We recommend utilizing an integrated project team model to architect, plan and manage the implementation. This approach minimizes your chances of incurring unexpected budget overruns and schedule delays.
At a minimum, project team members should include systems engineers from QbD Process Technologies and the user’s process automation project team lead, process equipment suppliers (i.e. tablet presses, feeders, etc.) and engineering firm. This model emphasizes close collaboration and direct communication between project team members starting with the initial front end engineering and design (FEED) phase through project scoping, implementation, startup and system commissioning.
At the front end, it is essential the project team mutually review the User Requirements Specification (URS) to agree upon the scope of work, the optimal system architecture, control network communication protocols, and process control and data management strategy for monitoring and controlling the critical product quality and process performance parameters defined in the URS.
Our experience has shown that deploying an integrated project team model from project conception to completion enables key project stakeholders to stay focused on assuring the user’s URS is clearly understood and met.
If you would like to learn more about QbD Process Technologies and how our ContinuousPlant® Software Suite of products and services can be applied to your continuous manufacturing process, please contact us to request more information.
Sunday 03.03.19
IFPAC continues to set precedence as a forum for insightful discussions bringing you the latest trends and real-life applications in the fields of Quality by Design, Process Analytical Technology, Quality
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