Flexible MES in a Global Pharma World

While MES solutions in the Life Science market have existed for over 20 years, it hasn’t been until recently that those solutions have started reaching across a single plant into a single enterprise solution.  Through enhancements in the integration with ERP and Controls systems, as well as the flexibility to handle plants of all types and purposes, MES vendors have reached out to satisfy the needs of their Global Pharmaceutical customers.

Research and Development

R&D manufacturing has always been a significant challenge for Manufacturing Execution Systems (MES) as the flexibility of the research process makes it difficult for many software vendors that are typically focused on “controlling” the manufacturing floor.  To overcome this challenge, MES software companies have added flexible steps to their product suites.  These steps allow for special cases such as allowing any material or equipment to be added without being “planned” as part of a bill of materials or a bill of equipment.   This functionality allows for R&D operations to properly document each activity, thereby ensuring valid lots and equipment are recorded in the electronic record.  By simply changing a few configurable options within the product, R&D users can change materials, equipment and instructions while in production and the system will record each activity in an electronic batch record as well as in enormously useful databases that can be used to easily capture and query production data.  This capability provides companies with the ability to maintain some level of control of the R&D process – such as:

·         verifying that the material, lot and quality statuses of each ingredient are valid before consumption

·         verifying that equipment statuses are valid before continuing processing

·         capturing all deviations from the expected process

·         real-time updates of inventory and financial systems

Pilot Plants

As the possibility of a new product progresses closer to become a reality, pilot plants are used to determine how small or large the production process can be to make the product economically feasible.   Many MES vendors allow for this flexibility by defining batch material and equipment scaling easily within their process recipes.  The system performs all required calculations to make sure that all materials and equipment are sized appropriately, without asking operators to manually perform these calculations on paper.   By making MES recipes highly scalable, pilot plants can focus on determining the correct equipment and product constraints without the added cost or trouble of manually updating paperwork systems. Again the reportable database becomes extremely useful, as the results of multiple batches can be analyzed to determine the best production environment and parameters for each product.

Multi-Product Manufacturing Facilities

Manufacturing multiple products within a single facility can be difficult for some MES systems.   While the processes and equipment may be similar between products, the materials and their parameters are potentially quite different.   But the latest version of many MES software packages provides for the capability to ‘parameterize’ almost every aspect of a recipe, thus making the recipe more flexible right up to the point of production execution.  Recipe authors can create process operations which utilize placeholders for parameters such as instruction text, timers, process limits, materials, and equipment classes.  Since populating these recipe placeholders with run-time values can be deferred until later in the process when the actual values are known, an MES system can now be used to standardize the manufacturing floor across multiple products.  Additionally, MES systems provide tools to make authoring recipes as simple as cutting and pasting reusable operations and filling in the deferred parameter values.  This activity allows for planned, predictable manufacturing throughout the facility and provides for cost improvements in training, fewer operator errors, SOP maintenance and product consistency.

Global Manufacturing

As manufacturing specialization and tax laws make it more beneficial for companies to begin production at one facility and complete production at a second facility – sometimes in a different country – genealogy, material and equipment management, and recipe consistency across sites becomes an even greater challenge.  MES vendors are addressing this challenge by creating enterprise solutions.  Web Farm systems that can maintain specification data for all worldwide sites can be implemented to allow for:

• easily transferring recipes from one facility to another
• sharing operation templates to create process improvement and commonality across facilities
• globalization capabilities which display on-screen text in the primary language of each logged on user
• a single repository for genealogy and inventory information across facilities

Control System Integration

 To achieve a more fully-automated and tightly-controlled production environment, integrating the Manufacturing Execution System with the process control system is a growing trend throughout the pharmaceutical and biotech industries.  Many MES vendors are teaming up with control system vendors to provide seamless links between electronic batch record instructions and process equipment controls within a single suite.  For those pharmaceutical and biotech companies with existing process control systems already in place, MES offerings also have the capability to communicate using cross-platform interfaces.  Whether the solution is a single-suite or across platforms, the MES-to-control system links provide for significant benefits in the following areas:

• Inclusion of appropriate control system data directly within the electronic batch record
• Verification of material and equipment statuses prior to control system recipe start
• Ability to call up manual process phases in MES from within the control system recipes
• A single-screen user interface to simplify operator involvement

Global MES benefits 

While the implementation of an MES system is always challenging, the rewards and return on investment is higher than it has ever been.  Some of these benefits include:

• Reducing inventory
• Shorter time to market
• Quality review by exception (automatic lot release)
• Reduction in Compliance costs
• Reduction in indirect labor
• Ability to move products to multiple plants
• Planned, predictable performance

Now might be a great time to check out what the MES vendors have to offer to put your enterprise on the road to flexibility and predictability!

Mike Eiselt

President – Enhanced Information Solutions, Inc.

Stillwater, MN USA

Tel: (651) 351 9227 x201

Fax: (651) 351 2762

meiselt@eisincorporated.com

www.eisincorporated.com