Continuous Manufacturing in Pharmaceutical production
Pharmaceutical Process design often aims at implementing a fixed and validated process that can produce on-spec materials, which can be confirmed by quality testing.
However, the combination of a fixed manufacturing process and normal variations in environment, equipment, and material properties can, and often do, produce products that fall outside specification (OOS), with high impact on cost and/or quality delivered to customers.
Investing in technologies supporting continuous manufacturing in pharmaceutical industries can not only reduce OOS materials but also reduce costs in both commercial and clinical processes when developing new products.
Continuous manufacturing is a process used to manufacture materials without any interruption using flow production. This in contrast with existing batch methods, where materials are processed on different stages of the process train in batches. The process itself gets interrupted after each stage, which makes it difficult to relate material attributes to process conditions and product attributes.
Below we summarize the main reasons why continuous manufacturing should be preferred above batch processes by pharmaceutical industries now and in the future:
- From a drug development perspective, Continuous Manufacturing is allowing manufacturers to only use the amount of material needed to investigate the integrity of processes. Hereby reducing the amount of API needed to support R&D processes and saving significant amounts of costs.
- Continuous manufacturing can increase overall quality and reduce OOS materials due to the ability to devise control loops across operation units based on real-time data while running the process. This allows modification to be made throughout the process rather than correcting after a full batch is processed. This can lead to continuous improvement of the process reducing testing efforts and assuring quality to clients.
- Increasing flow in your production process will reduce throughput time and limit manual intervention needed for the same amount of produced material. Controlling cost drivers such as manual labor and reduced set-up time will have a positive impact on cost-savings.
- Steady-state unit operations (feeding, blending, compaction, and so on) make it easier to characterize a process as it does not vary over time. This makes it less complex to relate material attributes to process conditions and product attributes.
Read the FULL ARTICLE "Solving The OOS Problem With Continuous Manufacturing" (Source: Pharmaceutical Online).
How can we at CMAST help?
CMAST can add value by emphasizing the benefits of continuous manufacturing processes in pharmaceutical production environments. Our consultants and Project Managers can support in implementing continuous manufacturing processes where YTD batch processes are running.
Maxime Van Rymenant, Business Consultant
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