Improving Logical Changeover Production Readiness in the Life Sciences

Improving Logical Changeover Production Readiness in the Life SciencesPharmaceutical and biopharmaceutical manufacturers have long felt the pressures of moving products from discovery to delivery as fast as they can—even given the highly regulated industry in which they operate.

Technology has continued to advance and provide ways to assist these companies with production readiness. Improper set up and qualification of automation and information management production applications cause start-up and product changeover delays, as well as slow performance during production runs.

I caught up with Michalle Adkins who shared with me four ways to improve production readiness. They include logical changeover, physical changeover, control strategy and data integration. We’ll explore logical changeover in today’s post.

Logical changeover is the time spent ensuring facility fit, configuring, testing and validating automation and information management solutions. By taking advantage of modern digital solutions and advanced applications for transferring both new and existing products to new or additional sites, these time intervals and effort expended can be decreased.

Some applications that reduce these time intervals and efforts include flexible recipe technology transfer & management, single-use bag assemblies with reliable process measurements, digital twin for validating and testing, valve piloting, clean-in-place optimization, and dynamic recipe activity design.

A set of flexible recipe technology transfer & management applications [Fluxa PKM in conjunction with PCS and MES systems such as DeltaV and Syncade] converts the traditional paper-based process to a data-driven, electronic work activity. These applications minimize manually managing process & recipe information, enable greater collaboration, minimize information movement time & effort, and shorten the technology transfer process to maximize time during patent protection. Additionally, Dynamic recipe activity design incorporates a library of class-based, parameterized DeltaV control system and Syncade MES building blocks including business activity objects, equipment-based activity, and dynamic transitions between elements.

With easy to use, accurate and reliable Rosemount single-use pressure and pH measurement devices with a good shelf life already gamma irradiated and delivered on single use bioreactor bags, consumables use, disposal costs, and personnel costs to manage bag inventories and availability can be minimized.

A digital twin solution, such as Mimic dynamic simulation integrated with DeltaV control system can be used to test control system strategies prior to deploying to production. The system can also be to train operators on various scenarios for specific process events.

Valve piloting typically requires valve automation configuration mapping into the controls platform. Redundancy is typically not available risking single points of failure around these valves.

Technology innovations such as the AVENTICS 580 DeltaV CHARM node and 500 series valve manifold with plug & play recognition by the DeltaV system reduces configuration and commissioning times, provides valve status locally and at the operator stations, uses redundant power and communications to improve overall availability and avoid single points of failure, and enables hot swapping to keep the production running in event of a valve failure.

Visit the Life Sciences & Medical section on for more on the technologies and solutions that drive improved performance in the logical changeover across the product development and commercialization lifecycle.

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