Pharmaceutical manufacturing has to meet high demands every day, but processes like batch manufacturing can lead to reduced quality and inefficiency. With an industry worth over $1.25 trillion globally, revenue losses can be just as substantial.
Continuous manufacturing provides the opportunity to increase product quality via enhanced process control and understanding as well as designing the quality control into the system, rather than relying on testing materials at the end.
Advanced software systems allow for comprehensive process control, tracking all production steps and ensuring the finest quality product. At COPA-DATA, our zenon Software Platform zenon provides unmatched advancement in continuous manufacturing.
The challenges of conventional batch manufacturing
Batch manufacturing is a standard process in the pharmaceutical industry, but it comes with challenges like:
- Manufacturing time: Conventional batch production relies on several days of batches moving through designated steps, ultimately creating less product in more time.
- Footprint: Traditional batch systems rely on a series of rooms and equipment to complete each step in the production process. A larger footprint leads to greater spending and prevents manufacturers from taking on more responsibilities and producing more product.
- Delay time from batch end to batch release: With extensive testing, batches may not be ready for release for a few weeks, delaying revenue gains and requiring more manpower.
- Number of quality controls: Relying on workers to handle quality control means that only a small portion of every batch receives a thorough examination, increasing the likelihood of lower quality.
The benefits of continuous manufacturing
In contrast to batch manufacturing, continuous manufacturing is designed to increase flexibility and agility (e.g. various batch size), but with the same exact and consistent quality — both for high and low volumes. With an enhanced level of process control, this method of production leads to benefits like:
- Flexibility: Continuous manufacturing doesn't depend on extensive development to operate, and it's not fixed. These lines easily adapt to market changes and higher demands without a lengthy and expensive line scale up. It also provides quick responses to shortages and emergencies.
- Improved quality: With Process Analytical Technology (PAT) and new process control strategies, continuous manufacturing reduces human error and improves product quality. It also offers quality control in real time, eliminating delay times dedicated to testing.
- Innovative processes: With new analysis technologies and advanced control systems and models, manufacturing lines can vastly improve their processes. With the integration of Real Time Release, product lines can release product sooner without sacrificing quality.
- Reduced costs: Continuous manufacturing ultimately reduces money spent with less processing time and waste and smaller footprint requirements to operate.
How zenon ensures continuous manufacturing
zenon is an intelligent, easy-to-use software platform to create comprehensive process automation for continuous manufacturing. Benefits include:
- Equipment integration: zenon's communications capabilities and openness allow for seamless integration with PAT, MVDA and automation systems.
- Integrated services: zenon includes essential services like historian, recipe management and batch control that are simple for engineers to configure and easy for operators to use.
- Comprehensive reporting: Our platform allows for efficient creation and distribution of different types of reports like batch report with exception report, statistical process control, overall equipment effectiveness (OEE) and more.
- Ready for the connected plant: Real-time and historical data can be easily exchanged with other IT systems (MES/ERP) thanks to standard communication options.
- Flexible production: With multiple options in Service Engine architecture, zenon can adapt to production changes with ease.
- Ensured quality: Create customized views for critical process parameters (CPPs) trends and deviations to catch problems before they multiply.
- Reduced validation work: Thanks to out of the box and configurable functions and services according to GAMP5 SW CAT.4, zenon reduces the effort in validation activities.
Contact COPA-DATA for pharmaceutical continuous manufacturing
Continuous manufacturing presents a new approach to pharmaceutical processes. With zenon, the accuracy, efficiency and adaptability of this manufacturing method are possible. zenon's user-friendly interface paired with advanced system processes empowers workers and improves your product line.
COPA-DATA has over 30 years of experience in the software industry, making us a trustworthy choice for pharmaceutical continuous manufacturing. We continuously improve zenon to ensure it meets the necessary algorithms and logic.
Introduce continuous manufacturing to your product line with zenon!