When you have all of this in place, you are nearly there. The next logical step is to use performance monitoring to optimize existing processes and systems, and the BTS PerMonDo product offers this functionality. Continuous monitoring of process and production system benchmarks, which are described in the key indicators, can help enhance process and product system performance and reduce manufacturing costs. Typical key performance indicators are: energy consumption (e.g. solvent concentrations, steam consumption at a specific step in the process); product quality (concentration of chemical components, contamination, secondary component residues); production system utilization (throughput, yield, changeover, retrofit); availability (deposits, blockages, malfunctions, alarms, shut-downs). It is important to assess the key performance indicators in relation to the theoretically possible process state, and rigorous process models are normally needed to do this. Once this assessment capability is in place, performance monitoring can help the engineering team to run the process in a nearly optimal state. The real challenge is to eliminate manual intervention and automate the process based on the key performance indicators. In today’s complex world, for example when large production systems with multiple process steps are started up or shut down, this level of automation is not always easy to achieve. That makes it all the more important to assess the benefits early on using DMAIC analysis.
Process analysis technology
Brief reference was made above to the fundamental importance of real time product quality monitoring in the operational excellence context. Right up into the 1990s, process analysis was focused on measurement outside of the production process to ensure environmental protection and occupation safety. In the meantime, the importance of quality-based process control as a key performance indicator has become equally important. Versatile BTS online process analysis systems are able to acquire virtually any product data. The list includes SpectroBAY, a spectrometer system for process applications, which is available in NIR, MIR, UV and Raman versions, and the BaychroMAT chromatograph which supports the full range of chromatography procedures. All of the systems are fully automated and are supplied with all of the standard process interfaces, a monitoring system and remote diagnosis features. The special Analyzer Results Transfer Software presents the quality data on the process control system in a familiar format, namely as a process control point. BaychroMAT Bio HPLC and BaychroMAT CellCount are innovative online bioanalytics products. Using these tools, it is possible to deploy fully automated fermentation process control based on cell count and protein concentration. This process equipment has a sampling valve, which can be steam sterilized, as well as proven automation components.
What has been discussed for far applies equally to batch and continuous processing. In actual practice, most of the solutions have been deployed on continuous production systems, because energy and raw materials costs are a major competitive factor. A third cost factor becomes more prominent in batch production, namely utilization. This is where Manufacturing Execution Systems (MES) come in.
Manufacturing Execution Systems
Although the documentation and integrated production optimization functions go well beyond detailed production planning, we will concentrate on the planning aspect in the following discussion. One of the most complex MES systems ever deployed went into operation in 2000 at Bayer Crop Science. It is used in a multi-purpose production environment to link highly flexible production modules to production lines which produce specialty products in relatively short runs . About 200 production modules are available, and up to 40 of them can be combined to form a production line. Given this level of flexibility, the main objective of the MES, which is linked to the process control and Enterprise Resource Planning (ERP) systems, was to organize production. The MES identifies production runs and electronically allocates a production order, a recipe and a batch, automatically assembles manufacturer’s instructions and other production documentation, archives them with the batch records and performs module scheduling and coordination. This facility itself is manifesting operational excellence, already (see Fig. 5).