Many Pharma and Biotech companies are moving from conventional batch approaches to continuous manufacturing. The continuation of production means companies can minimise waste and energy usage, reduce changeover costs and better monitor drug quality on a continuous basis through data analytics and real time checks.
The US Federal Drug Administration (FDA) are heavily supportive of this switch due to the increased process reliability and flexibility it brings, as well as the fact that it shortens production time – whilst minimising the risk of human errors. Other known benefits also include a reduction in production costs of between 15-30%, higher OEE 75%+, a 60-80% reduction in end to end batch lead time, and up to 50% reduction in product deviations.
However, continuous manufacturing is not easy to implement in the highly regulated pharmaceutical industry.
For it to be successfully implemented, the technology supporting the process must be integrated and installed correctly. Without checks between batches, the only way to ensure quality and compliance is through data analytics tools and real-time monitoring. Data Analytics tools are central to the continuous manufacturing environment in order to look through massive data sets quickly and spot any potential impacts on production in real-time. This predictive and prescriptive style of manufacturing will set the pharma companies of the future ahead of others.
- Process knowledge of Continuous Manufacturing best practice
- Concept development, design construction and testing
- Automation system implementation for equipment monitoring, process tracking, monitoring and control, resource utilisation and facilities
- Integrated data collection systems for process measurements, alarming and reporting
- Implementation of sensor technology and in-line analytics
- Internal testing and facility commissioning and qualification support
- System support after go-live
Zenith prides itself on being vendor independent and although we have a lot of experience utilising different continuous manufacturing solutions, we use the best possible solutions based on our customers’ requirements. Get in touch with us to talk about your continuous manufacturing goals.
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