Steve Zarichniak, Technical Solutions Consultant, Honeywell Process Solutions05.05.21
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:
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:
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:
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:
Steve Zarichniak has been with Honeywell International for 37 years and is located in Fort Washington, PA. His position is a Technical Solutions Consultant focused on the Specialty Chemicals and Life Sciences market. Steve has traveled extensively worldwide and is heavily involved with industrial batch process applications. He has authored several papers for ISA, World Batch Forum, ISPE and Interphex. He holds a Bachelor's degree in Electrical Engineering from Penn State University and is a registered Professional Engineer.
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.
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.
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
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 manfacturing;
- Enhanced virtual simulation reducing validation effort;
- Shorter time to complete design and engineering; and
- Quick response to product demand fluctuation.
Steve Zarichniak has been with Honeywell International for 37 years and is located in Fort Washington, PA. His position is a Technical Solutions Consultant focused on the Specialty Chemicals and Life Sciences market. Steve has traveled extensively worldwide and is heavily involved with industrial batch process applications. He has authored several papers for ISA, World Batch Forum, ISPE and Interphex. He holds a Bachelor's degree in Electrical Engineering from Penn State University and is a registered Professional Engineer.