Automation Industry Association

Fueled by the adoption of industry standards and advances in technology, ERP is being embraced by the Life Sciences industry in this country along with the usage of the control systems at the shop floor level to automate the manufacturing process. Despite usage of such systems there is still an element of disconnect between these systems which would qualify as a component that is left unaddressed by the manufacturers. This component involves the optimization of the production process, paperless recordkeeping, real time tracking at the shop floor etc. These unmet needs are addressed through a set of solutions which are known as Manufacturing Execution Systems (MES). The following paragraphs of this article give a further perspective on the uses and the capabilities of MES.

Comprehensive Production Management:

From creating master batch records for products, to executing processes consistently across manufacturing, to measuring plant productivity-MES covers all activities and requirements. MES provides manufacturers the ability to view, control and track all aspects of production on the plant floor, including materials, labels, work-in-process, equipment, work instructions, facilities, labor and documentation. The system manages these aspects through every step of the manufacturing process-from initial receipt of raw materials through weighing/dispensing, blending and packaging activities. By guiding operators and equipment through the manufacturing process with interactive, step-by-step dialog, MES ensures that products are manufactured and packaged consistently at the lowest possible cost.

Managing Critical Data:

Good MES systems provide a central repository for materials, equipment and procedural data that is very vital for the Life Sciences industry. This data from the birth of the molecule through its laboratory / bench scale to pilot and commercial scale production is managed very carefully.

MES enables flexible definition system that allows all materials, equipment and procedures to be defined. MES should also provide the standard recipe model with (General/Site and Master level recipes) with specification for Materials and Equipment at these levels. This helps in setting up newer plant taking lesser time than normal because the master data/recipe only needs to be altered to specify the new location thus making the scale up easy and less time consuming.

Product Lifecycle Management (PLM): From drug discovery to commercial production, all the data is stored and available for usage. The molecular level data is converted into the bench-scale recipe which further gives rise to pilot recipe and commercial production recipe. MES ensures data is not lost and relationship between various recipes is also maintained. It is a single source for managing the product (its specs, versions, etc) throughout its lifecycle. Workflow for internal approvals for the drug specs (since its discovery); also while transferring the recipe from bench scale to commercial scale, etc.

Integration with External Systems:

MES provides integration with Enterprise Resource Planning (ERP) systems, Supply Chain Planning systems, Laboratory Information Management Systems (LIMS), Document Management Systems and equipment control systems, so manufacturers gain two-way communication between the plant and the rest of enterprise. The translation of plant floor data to enterprise formats makes MES extremely valuable, not only as a system for managing the plant and leveraging your supply chain, but also for providing information to executives for smarter, faster decision making.

Integration with ERP/SCM: MES integration with business systems such as ERP/SCM aids in simplifying lots of processes. For e.g. it is possible to allow the ordering process in ERP and receiving materials against that order in MES. MES ensures to check if right qty and quality of material is received (as ordered in ERP). Integration eliminates duplicate entries and manual errors. Suppliers can be paid based on MES feedback to ERP on the receipt of material. Thus tight integration between ERP and MES helps in improving the productivity through simplified processes.

Integration with Shop Floor Devices: MES can integrate with control systems such as PLC/DCSs via serial interface, OPC server and other available technologies. It also interfaces with Weighing scales and other analytical devices to capture real-time data via mostly serial interface. While executing, MES accepts various manual inputs/acknowledgments from operator that become part of the batch record. Thus, MES helps in providing an integrated compliance record for both manual and automated data.

MES compared with External Systems:

This paragraph outlines some of the activities that is done using MES which normally is not part of the external systems like ERP, PLCs, etc.

• Direct interaction with the operator on the shop floor
• Controls and checks manufacturing operation on real time basis
• Convenient recipe management
• Strong access controls and concept of electronic signatures
• Continuously monitors the process and provides analysis for improvement
• Eliminates errors and logs deviations
• Enforces Good Manufacturing Practices
• Reports deviations real-time and demands QA interactions for further processing
• Schedules your assets and increases overall equipment effectiveness (OEE)
• Container-wise genealogy or traceability
• Strong and effective on all regulatory guidelines and compliances
• Streamlines finished product release on basis of quality and customer requirement
• - Generates an EBR with a special page highlighting deviations
• - Process locking in case of deviations
• - Enhances decision making power and reports Key Performance Indices' performance

Benefits from MES:

Some of the benefits that can be gained by using MES are:

• Enforces compliance and reduces errors
• Reduces validation efforts
• Improves throughput
• Reduces operating costs
• Increases schedule attainment
• Enables greater manufacturing responsiveness
• Process locking in case of deviations

G. Anand Shankar