As a result of growing challenges such as an expanding global market, increased competition, reduced product life cycles,
modular processes, and changing product demand, pharmaceutical companies are searching for innovative ways to improve their
production processes. Historically, the pharmaceutical industry has been conservative in adopting new manufacturing technologies.
This caution can impede the ability to operate best-in-class facilities. But innovative solutions can bring benefits such
as the following:
- Reduced production cycle times by using on-, in-, and/or at-line measurements and controls
- Increased yield and capacity
- Continuous processing to improve efficiency and manage variability
- Improvement in energy and material use
- Real-time release
- Increased automation to improve perator safety and reduce human errors
- Improved quality by design through better technology transfer.
As companies strive to achieve these improvements with fewer employees and resources, many are looking at automation suppliers
as strategic partners rather than as vendors. The changing expectation is influencing automation suppliers' strategies and
investments. Automation suppliers are expanding product solutions to perform new functions (e.g., ISA95 Level 3) and broadening
their service capability to become main automation contractors (MACs). These strategies are reviewed below.
Expanding product functionality
In the current market environment, automation suppliers are investing in solutions that address ISA95 Level 3 operations-management
functionality. The ISA95 Enterprise-Control System Integration standard helps manage people, equipment, materials, and energy
within a manufacturing facility by defining data models, work activity, and the information exchange of operations management
The ISA95 standard divides the management of manufacturing operations into four categories: production operations, inventory
operations, quality operations, and maintenance operations. The activities defined in Levels 1–3 are critical to plant safety,
reliability, efficiency, product quality, and maintaining regulatory compliance. Within Level 3, several operations-management
functions are defined for each of these four categories: definition, resource management, detailed scheduling, dispatching,
execution management, data collection, and analysis.
Three ISA95 concepts critical to pharmaceutical-operations management include integrated workflow and recipe optimization,
integrated documentation and document management, and integrated manufacturing operations throughout the entire facility.
A single recipe, that addresses both manual and automated activities can optimize operations by reducing operator errors and
variability, coordinating process steps, and minimizing engineering efforts. A single recipe also enables comprehensive batch
documentation records to be generated in real time.
Managing documents extends far beyond electronic batch records to include information such as material-safety data sheets,
standard operating procedures, design documents, testing documents, and training records. Regardless of the format or source,
this information needs to be managed throughout a product's life cycle, and any change management must be addressed.
Facility integration optimizes resources and synchronizes interdependent activities. The data models and transaction standards
outlined in ISA95 can lead to easy, maintainable, functional integration. Standards-based communication methods and web services
can further ensure easy use, integration, and maintainability of these solutions. Overall, the models and standards allow
companies to connect real-time plant floor manufacturing data with enterprise applications.
In addition, advanced control techniques such as real-time principle component analysis modeling can help optimize the manufacturing
process. Predictive diagnostics can be implemented to avoid further equipment deviations. Other technology enhancements that
improve manufacturing include wireless access and radio-frequency identifcation (RFID).
With these technologies, Level 3 solutions facilitate closed-loop control for manufacturing activities, thereby allowing pharmaceutical
manufacturers to make business decisions in real time. In turn, the traditional real-time domain of automation suppliers is
naturally extended into Level 3 functionality. Manufacturers will realize the benefits of having their complete real-time
environment provided by a single partner.