Background

Toyo Engineering Corp (TEC) offers integrated engineering solutions to both the domestic Japanese and regional export markets. Its "e Solution" business unit provides systems engineering, plus software development and sales support. These ensure maximum return on assets (ROA), integrated IT, and professional project management.

TEC has extensive experience and knowhow in the planning and deployment of supply chain integration, system integration, and plant construction across a wide range of industry groups, including the pharmaceutical sector. In Japan, TEC is the nominated distributor for Propack Data (a Rockwell Automation business) and its Enterprise Production Management (EPM) solutions for the life sciences industry.

Growth for pharmaceutical manufacturers is a process that's different from most industries. It often takes many years to research and develop a new product and get it through the approval cycle. Then, the race to ramp up to full-scale production and distribution begins, as the company seeks to get the greatest return on their investment, as fast as possible.

To be competitive in the consumer pharmaceutical industry, manufacturers are under intense pressure to minimize costs as they also meet standards and manufacture products as quickly as is safely possible. As a matter of fact, 9 of the top 10 pharmaceutical manufacturers globally use Propack Data PMX to do just that. MES implementations improve and standardize processes, smooth R & D and production operations, and enable them to comply with regulatory standards for manufacturing such as FDA Part 11 and Good Manufacturing Practice (GMP).

When production volumes are based on past sales trends and projected sales, manufacturers need to be able to rapidly scale production when demand differs from the projected volume. Therefore, a successful MES includes close supply chain monitoring in addition to optimized manufacturing processes. It does this by:

• Recording processes accurately, thereby providing "traceability," which is often lacking and is a major aid to compliance management


• Measuring processes (i.e. KPI -- Key Performance Indicators) and often other important process information currently locked in paper records (this feeds into continuous improvement and responsive manufacturing best practices)


• Enforcing processes to help establish workflows that make desired outcomes routine (enforcement of consistency), another major aid to compliance management.

Each day that a company reduces time-to-market and improves productivity increases revenue, but in the pharmaceutical industry, that day saved also might make the difference between someone living and dying.

Challenge

Successfully distributing products around the globe requires that the quality of the offerings is validated -- they must meet international regulations as well as consumer expectations. That quality validation is dependent on compliance with global standards including GMP, "Computer System Validation," and regulations pertaining to electric signature and records that are required by the FDA for pharmaceutical products exported to the U.S.

A major Japanese pharmaceutical manufacturer had constructed a new weighing room, updated their old weighing system, and decided to implement MES for all their future processes. TEC founded its proposal for this manufacturer on the Propack Data PMX MES™ solution, making specific use of the Propack PMX Dispense MES function set. The pharmaceutical manufacturer accepted the proposal because it understand that PMX Dispense MES presented the ideal solution, as it supports the wide range of automated weigh and dispense activities typically found in drug manufacture.

The plant's MES application presented some unique problems. They wanted to localize the application, which meant adapting the software to display information and control parameters in double-byte characters, accounting for cultural differences, and accepting the uncertainty that naturally accompanies being the first users of a modified version of software.

And, although the MES was to be implemented in Japan, development was being conducted in Germany. Therefore, it was necessary to provide testing conditions that took into consideration the time difference between Germany and Japan. Once the system was ready for installation, it was important to carefully plan the transition from the legacy system to the new process.

Also, this was to be TEC's first experience with this solution. Consequently, they were open to accepting the technical advice that the user could contribute. At the end, TEC has completed this installation, founded smooth future implementations, and improved support to the operational MES. During the course of the project, TEC proved to be the right system integrator for the job.

Solution

As the foundation for the solution, TEC implemented the PMX Dispense MES Function Set, as the MES architecture, which handles dispensing, basic data collection and analysis, and container management. Although localization added development challenges to the existing manufacturing execution system and overall project, TEC completed the whole process in one year by working together with the user.

Propack Data PMX is the software that enables control and communication within the Function Set. It is the heart of the system, serving as the data conduit and control bridge between the weighing machines and the SAP. It also tracks raw materials and containers by reading bar codes, and even provides supply chain management features for maximum asset management.

Breaking down the implemented MES further, we find that the PMX Dispense MES Function Set includes control over the weighing instruction creation, provides weighing machine control, assigns weighing operations, produces weighing records, and confirms the status of raw materials.

This Function Set is also the master management component in the MES. It manages the bill of materials and product recipe, containers, and other change management controls such as authority management, preventing unauthorized personnel from operating or modifying the MES. It also keeps the log of changes, documenting alterations and who was responsible for the change.

Finally, container management is executed through the Function Set. It delivers feedback on the status of weighing containers. For example, it determines whether a container is rinsed and ready for the next step in production.

Looking at the total system, the MES manages everything from the manufacturing orders and the raw material consumption, to the weighing machine control and container handling. The localized software runs on Windows 2000 Professional, with system parameters displayed in double-byte characters, and is networked to an Oracle 8 database for data storage and management.

Results

Production costs are satisfactorily reduced, since the plant's new MES improves and standardizes operations in the weighing system. It also aligns R & D and production, and integrates supply chain management in the future. Integrated supply chain management further increases profitability, making it easier to manage stock and respond to consumer demand.

A critical expectation is the system's ability to comply with FDA Part 11, GMP, and CSV regulations, making it possible to export their products globally, increase global market share, and elevate revenue when they implement the expanded system.

The company is also more profitable, since it has increased operator productivity by 30%. That increase in productivity in the weighing system has enabled the plant to reallocate those people to other tasks in the facility. The plant retains skilled, already trained employees, who can then contribute to other parts of the overall manufacturing process. Although difficult to quantify, the value of the intellectual property -- the knowledge base and experience that employees acquire over time on the job -- further increases the return on investment.

Lower labor costs are also realized as a result of the system automation, which both reduces the number of operators needed to produce goods and simplifies the process so much that less-skilled personnel can run the system. It also reduces inevitable human error, particularly in relation to setting equipment parameters, which now is done automatically and with high precision.

It's here that the localization effort pays off. As a result, the learning curve is reduced and operators are by nature more inclined to adapt to the human machine interface (HMI) and in turn the entire system.

The new system makes generating validation documents easier and faster. The automatic data acquisition reduces the labor expended creating manufacturing records and streamlines troubleshooting system errors, drastically reducing downtime and pinpointing troublesome faults in the manufacturing process, which can then be quickly rectified. Plus, the system ensures that manufacturing operations are being conducted within written operational standards, a critical test for global distribution of finished products.

Finally, the new MES speeds product development and time to market, which just might help ease suffering or save a life.