Integrated solutions for pharmaceutical manufacturing

Using MES systems to bridge the gap between ERP world and shop floor has become a widespread approach. Flexible MES concepts developed by SAP and partner companies now illustrate just how clever SAP-based manufacturing solutions for integration, intelligence and execution scenarios can be.

Higher Production Flexibility through Transparency and Integrated Processes
Caught between the conflicting demands of cost pressure, high quality standards and changing requirements of the market, shop floors today are facing one challenge more than ever before: the capability to act quickly and flexibly. Basic requirements to meet this challenge are a high transparency on the shop floor and the availability of real-time information. Filtering the multitude of accumulated data to provide exactly the pieces of information relevant to a certain person is key, as is presenting this information in the right place, at the right time and in an adequate display. This also goes hand in hand with integration of the production processes into other business units and divisions. The goal is not only to reduce the large number of subsystems and manual actions on the shop floor and to establish a real-time, paperless information flow, but also to integrate information from various business processes.

It is only on the basis of such an efficient data and information management that MES tasks can be optimally realized in pharmaceutical environments.

Manufacturing Integration, Intelligence and Execution with SAP
To meet the obvious demand for smart manufacturing solutions, SAP AG expanded their respective product portfolio and their network of experienced solution and implementation partners. The SAP MII integration software (Manufacturing Integration + Intelligence) provides a flexible “toolbox“ to solve MES tasks in a portal-based, individual approach.

The solution enables standardized connection and visualization of production processes with all enterprise business processes in real time. SAP MII is equipped with numerous standard connectors to integrate machines and systems of shop floor and ERP level. In addition, comprehensive tools for business logics and visualization are available to support or automate production processes and to enable and generate KPI analyses.

Expertise in Innovative Integration Approaches
As Special Expertise Partners for MII in Life Science environments, German specialists Trebing & Himstedt provide the necessary consulting and implementation know-how for the shop floor. Having its roots in the automation sector, the company has grown to be now the most successful MII partner. Five of the global Top-10 pharmaceutical companies already trust their integration competence.

Based on SAP MII, Trebing & Himstedt developed their own Best Practice solutions which provide pre-configured templates for typical MES scenarios. With these standardized implementation methods, respective tasks can be realized quickly and with little implementation effort. Well-proven solutions are available for the areas of Machine Data Acquisition, Production Data Acquisition, Electronic Work Instruction, Quality Management, as well as downtime and failure analyses (OEE) within the scope of KPI Monitoring. With regard to Tracking & Tracing, these Best Practice solutions also form the basis for the management of mass serialization processes.

Compared to other MES systems, smart MES solutions based on SAP not only provide a seamless integration of SAP ERP and shop floor level; they also ensure high transparency through real-time information. Thanks to the web-based concept, installation on clients and double data storage are no longer necessary. The intuitive web interface facilitates the handling for production personnel. Furthermore, MII-based execution solutions enable continuous manufacturing independent of ERP availability.

KPI Monitoring and Performance Optimization in Packaging Operations

By using smart KPI Monitoring solutions in the field of packaging operations, production processes can be monitored in real time and potential for optimization can be identified. Data from various sources of information inside the company are processed as respectively relevant and depicted via web browser in a clearly arranged display – in the required form of visualization and degree of detail. In this way, the TH OEE Best Practice (Overall Equipment Effectiveness) solution monitors and analyzes machine efficiency by means of KPI calculation, failure analyses and monitoring of the production process. A flexible role concept enables different views and selective evaluations: workstation view for machine operators, machine group and workstation views for shift supervisors, and complete view of all plants, equipment and machine groups for the site manager. This means, for example, that machine operators are constantly able to check their compliance to performance standards in real time via aggregated dashboards on the shop floor. Site managers, on the other hand, can also run detailed error analyses over a certain period of time. TH OEE Best Practice provides the following evaluation and analysis tools: KPI calculation, detailed downtime, failure and quality analysis with TOP-10 lists, quantity and time-based total-vs-target analyses, and overviews of orders and machines. The KPI solution also supports LEAN Manufacturing strategies inside the enterprise.

Practical Application: 
Production Information in Real Time – Increased Transparency on the Shop Floor by KPI Monitoring with SAP MII

At several sites, Novartis relies on KPI monitoring with SAP MII which integrates shop floor and administrative data from various application systems in real time. In the form of clearly arranged dashboards, production personnel is provided with all relevant information required to better check their compliance to performance standards.

“Operating staff on the shop floor does not need historic analyses, but up-to-date production status information 24/7. With MII, we have found a solution which provides all relevant data for the shop floor in an efficient way.“ Ralph Häfeli, Head of Global IT Systems, Novartis Pharma

“Project services from Trebing & Himstedt were part of the success – implementation and delivery were both on time and within budget.” Robert Fretz, Head of Process Automation and MES, Roche, Pharmaceuticals Division

Electronic Work Instruction with Integrated Quality Management for Batch Processes

The TH EWI Best Practice solution has been designed and customized for batch process requirements in process industries. It enables integration of shop floor and quality management processes in one single application at MES level. Retaining SAP ERP as the leading system throughout the complete process avoids double data management or maintenance. The solution’s local order queue ensures order processing on the shop floor independent of SAP availability and prohibits downtime and data loss in case of failures. An intuitively operable web interface guides production staff through the entire manufacturing process. TH EWI Best Practice generates respective electronic work instructions for selected process orders. Additional production documents, if available, are provided together with the work instruction. Flexible print-outs of labels and material lists can also be triggered from the process.

At the stage of order processing already, material consumption, incoming goods, working hours and machine times as well as quality data are entered directly into the work instruction by the operating personnel, or are automatically collected from a PCS/batch system. In this way, TH EWI Best Practice considerably reduces manual effort, paper-based work flows and the “black hole“, the information deficit during the ongoing production process. Confirmations to the SAP PP-PI or SAP QM system including electronic signature are forwarded and recorded near-real time.

Practical Application: 
Automation Integration Layer for Batch Manufacturing

“Together with Trebing & Himstedt, we developed an innovative solution for an integration layer between the shop floor and the ERP level. Based on SAP MII and TH Best Practice solutions, we could link our ERP system with the DCS system on the production line for the first time. This automated information flow replaces our formerly paper-based work flow and thus reduces manual work and the number of signatures required. Thanks to the seamless integration and the real-time connection to SAP, our production processes have become faster and more transparent.

After a successful reference implementation, we plan a global roll-out of the solution concept. During the entire project, Trebing & Himstedt professionally supported us with their experience and competence: starting from consulting and developing the integration concept via successful implementation up to a commissioning phase without any problems.” Production Integration directors | Top 5 global pharmaceutical companies

Perfect Laboratory: Integrated Solutions for Efficient Quality Management

The combined efforts and collaboration initiated by SAP and consolidated as “Perfect Laboratory” enhance the “Perfect Plant” initiative by SAP- and partner solutions for quality and laboratory management. Supporting PAT strategies, it aims at rendering the process chain of production and laboratory management more efficient by providing integrated solutions for various application scenarios. The respective elements, based on SAP MII, enable integration of quality management functions of the SAP ERP application into production and laboratory systems. In this way, laboratories are integrated with the manufacturing process in the best possible way, and cycle times can be kept short. Availability of real-time information translates into quicker and more flexible responses to quality problems on the shop floor. Automated data recording based on the connection of electronic master tools and consistent data management reduces manual effort and the involved risk of error. With the intuitive user interface, in-process controls used during production can now be carried out directly by the shop floor staff.

Electronic Batch Record based on Enterprise Historian

Practical Application: 
Electronic Batch Record based on Enterprise Historian

After a thorough evaluation process, Schering-Plough (former Akzo Nobel) opted for RAPID-Pharma as a Historian system for the biotech API production in Oss, Netherlands. It emerged as the only product meeting the project team’s complex requirements such as manufacturer-independent connectivity, support of standard interfaces, S88-based reporting and 21 CFR Part 11 compliance. Besides offering a speedy way to FDA compliance, support of the PAT initiative and safe data handling, RAPID-Pharma provides many technical benefits as well as ease of use.

At the heart of the Production-Information-Warehouse system, all real-time data, batch data, alarms and events of the process control system as well as data from facility management system are stored in RAPID-Pharma. The historian is responsible for all data capture and the generation of Electronic Batch Records. All process and plant information necessary for reporting and analysis are derived from this system. It operates 24/7 and records batches with a runtime ranging from several days to a number of weeks. Batch data, continuous data, alarms and events as well as the respective room monitoring data can be analyzed collectively.
“With a system such as RAPID-Pharma, we are in a much better position to speed up commissioning and optimize our facilities during operation. Only now are we beginning to realize the system’s full potential. We will expand it step by step. Extremely important to us is especially the system’s ability to provide access to all data in a database at any one time, and to allow generation of new ad-hoc queries without programming knowledge.”

In the meantime, a second large-scale project with RAPID-Pharma as the Historian system has been started in the chemical API production of Schering-Plough. Paul Jansen, former Project Manager, Schering-Plough (former Akzo Nobel)