Fast Track Automation in Pharmaceutical Manufacturing

There’s no doubt that pharmaceutical companies are under pressure to produce a wider range of products, and deliver higher quality, with fewer resources. Production sites must be more agile, with the capability to react to changing demands quickly.

Increasingly, drug manufacturers are turning to advanced automation technologies and project execution methodologies to compress engineering time, reduce inefficiencies and enable Parallel Planning.

Throughout the global pharmaceutical industry, there is a need to accelerate the delivery of medical solutions to patients by helping ensure more efficient production and testing capabilities along with facilitating a strengthened supply chain.

Leading manufacturers have made it a strategic initiative to go from development to production faster, with reduced cost and effort. Their specific objectives include:

·   Expediting new drugs and therapies to commercial production; and

·   Implementing scalable solutions for flexible manufacturing.

Today, pharmaceutical companies are intentionally manufacturing new drugs “at-risk,” meaning the product is produced at commercial scale before final regulatory approval. Shipment of the product can then occur immediately upon approval. Fast track implementations provide a stable, compliant, and exceptionally expedient methodology to achieve this end.

Innovative Approach to Deploying Automation

Experience has shown the most effective way to expedite production of new pharmaceutical products is to facilitate the design of full commercial-scale manufacturing earlier, while therapies are still in clinical trials.

Leading technology providers have developed “fast track” automation solutions that can be configured in a virtual environment and then implemented once a drug is approved and ready to be produced for patients. With this approach, plants can rapidly deploy out-of-the-box GxP-compliant automation solutions supporting 21CFR Part 11 across their production lines while reducing associated risk.

Pharmaceutical producers can now utilize flexible automation system builds with pre-structured engineering design scenarios based on whether legacy equipment will be repurposed, or new equipment installed. The typical automation scenarios, based on standardized GAMP5 Model definitions, include:

·   SCADA with manual data entry and manually driven control;

·   SCADA over process skids that require manual and/or automated controls;

·   DCS with new process skids; and

·   DCS with a mix of new and repurposed units.

Combinations of the pre-structured systems can be used to address the control requirements of individual units and skids, or even the entire process train. To further support the pre-structured designs, some automation suppliers offer solutions enabling an existing SCADA system to seamlessly evolve into a full-fledged DCS.

Fast track automation allows users to start critical production system development activities earlier and perform them in parallel in the cloud, and using virtual engineering, physically bind them at the manufacturing facility. This process, plus flexible I/O, allows late-stage configuration as the final step. The result is significantly reduced engineering time and effort, as well as faster ramp-up to full production.

Results from successful industry projects indicate that lean execution methodologies inherent in fast-track automation can speed up implementation and help to simplify final configuration. They enable at-risk manufacturing planning to begin during final Phase 3 clinical trials, using a single interface providing visibility across start-up and ongoing operations.

Technologies for Expediting Production Flexibility

Throughout the pharmaceutical field, new technology advancements are driving an improved end-to-end manufacturing process. The tools and solutions serving as fast-track enablers for flexible production include:

·   Digital Twins (Virtual Engineering)

·   Batch in the Controller

·   Control from the Data Center

·   Flexible Input/Output (I/O)

·   Orchestration Layer Connectivity

·   MES Seamless Interactions

·   Advanced Analytics

For example, digital twin technology supports parallel process automation development paths, making it possible to create a software-driven, cloud-based digital representation of production processes and assets using process simulation and validate the design in the cloud. Production systems can be configured in the cloud so that when expanded or modified operations are required, users simply access the database, without having to revalidate, and deploy the replicated system within a new production line.

The unique ability to execute a full S88 batch model in the process controller reduces the engineering effort required to design, modify, and configure a batch system. With batch running in a cloud-based controller and not in the server, an orchestration layer can be employed for direct batch automation with multiple production skids. This layer simplifies integration with legacy sub-systems and can support enhanced GxP compliance.

Impact on Pharmaceutical Manufacturers

Using the power of the cloud, virtualization, pre-designed automation solutions, adaptable I/O, remote asset management from a data center and efficient project implementation, pharmaceutical companies can prepare automation designs in parallel with clinical trials so production can be quickly mobilized once a therapy is ready for commercial scale-up.
The impact of fast-track automation on drug manufacturers includes:

·   Greater confidence when undertaking at-risk manufacturing;

·   Enhanced virtual simulation reducing validation effort;

·   Shorter time to complete design and engineering; and

·   Quick response to product demand fluctuation.

By employing the latest generation of automation tools and solutions, coupled with modular facility construction, pharmaceutical companies can go from trial and approval to production in significantly less time.