The pharmaceutical industry is embracing enterprise resource planning (ERP) and the concept of Service-Oriented IT Architecture, with a growing number of manufacturers building platforms based on SAP or Oracle.
However, drug manufacturers have also recognized the limits of such systems. As John Hagerty, vice president of research at AMR Research Inc., wrote in Industry Week last year, running global manufacturing enterprises on ERP is like driving down the New Jersey Turnpike in reverse at 65 mph using only the rearview mirror.
ERP architectures are optimized for transactional efficiencies rather than real-time reporting, he wrote. As a result, data historians, which collect process control and time-based manufacturing data, are becoming more important. They permit root cause analysis and facilitate the use of Six Sigma, and are considered a prerequisite for electronic batch recordkeeping.
Vendors such as Rockwell Automation, Emerson and Siemens have extended the data warehousing capabilities of their products by collaborating with OSISoft to add functions from the PI data historian. MES manufacturers such as Werum are using OPC standards to develop data warehouses that can be used to improve real-time data access.
The company used this method in an AstraZeneca facility in Singapore (see http://www.KnowPharma.com for a discussion of that installation). As a result, the role of the data historian is expanding and a new class of software has been developed to extract manufacturing data. Below are some platforms now being used by drug manufacturers.
We will be publishing case histories on specific implementations in future issues of the magazine.
Aspen InfoPlus.21 combines a stream processing engine, historian and application development environment. It offers one million historized data points at over 60,000 per second. The platform features an embedded drag-and-drop calculation engine and SQL environment, and offers an SOA-ready Web services adaptor. AspenTech, Burlington, Mass. www.aspentech.com
Robust Data Transfer
Surveying Industry Connectivity
S88 and S95 standards, in conjunction with GAMP4 guidelines, have provided a framework for developing, documenting, and maintaining automation and process control systems for the pharmaceutical industry.
Although the buzzword has been openness, during this period, some observers believe that the past 10 years have actually seen a retrenchment to proprietary hardware platforms and software applications. Scott Sommer, automation technology manager at Jacobs Engineering Group, has surveyed hundreds of end users in the pharmaceutical industry on what they would like the next generation of automation and process control to be like.
Mr. Sommer will present results of the survey at Interphex in Philadelphia next month, and we will report on his findings.
Historian (formerly known as i-Historian) provides an effective data repository to collect, archive and distribute large volumes of real-time plant-floor information. The platform can read all types of process data, offering a window into manufacturing operations across key matrices. It is designed to comply with 21CFR Part 11. GE Fanuc, Charlottesville, Va. www.gefanuc.com
Need for Speed
The Acumence platform is designed specifically for high-speed, continuous and discrete manufacturing. At its heart is the Plant Analytics Server, which creates a complete record of plant performance by taking high-resolution data from machinery and processes in the plant, recording all data, tracking all downtime and quality-related events. Acumence, Chicago, Ill. www.acumence.com
The Incuity solution presents a coherent picture of any manufacturing business through familiar browser and Microsoft Office interfaces. The platform features self-configuration capabilities and preconfigured reports providing immediate insight into manufeature facturing via real-time executive dashboards, automated production reporting, KPI monitoring and alerting. Incuity, Mission Viejo, Calif. www.incuity.com
Managing Performance in Real Time
Real Time Performance Management is the latest version of OSIs Process Information data historian. It records process control data into a compressed time-series database. OSISoft, San Leandro, Calif. www.osisoft.com
From Data to Information
Improving Analyzer and Sensor Connection
As connections between data historian and enterprise levels have improved, efforts are also underway to improve connectivity at lower levels of communication---specifically between the sensor and analyzer system and the data warehouse and enterprise level systems.
At the Center for Process Analytical Chemistry, a connectivity initiative has been working on establishing guidelines for improving open communications between sensor and analyzer systems and higher level systems. In January, the OLE for Process Control (OPC) Foundation set up a working group to develop a common method for data exchange and an analyzer data model for process and lab analyzers.
Pfizer, GSK and Abbott are among the drug companies involved in the project so far, as are the vendors ABB, Mettler-Toledo and Umetrics. The goal is to facilitate plug and play interoperability required for data management in process analytical technologies (PAT).
The RAPID-Pharma Manufacturing Intelligence Platform helps drug makers consolidate disparate islands of information throughout the manufacturing environment into one central layer. It works in all plants, regardless of IT and automation infrastructure, and connects with ERP systems. Automsoft, Dublin, Ireland www.automsoft.com
Storage of Time-Series Data
The Wonderware Historian collects, stores and retrieves large amounts of plant data cost-effectively, allowing data to be analyzed by a complete range of data clients. Historian builds on Microsofts foundation, adding specialized files that efficiently store time-series data in approximately 2% of the space required by standard SQL Server tables. Invensys Wonderware, Lake Forest, Calif. www.wonderware.com
Enhanced Modeling and Interpretation
Discoverant integrates investigational analytics with data connectivity to provide real time, on-demand data access, and facilitate collaborative analysis of manufacturing and process development data and reporting. The software maps and maintains the data type and batch relationships in data from LIMS, SCADA, EBR/MES, ERP and even paper records, to identify sources of process variablility. Aegis Analytical, Lafayette, Colo. www.aegiscorp.com
Trace Root-Cause Problems
The Informance Enterprise Solution features a data warehouse that aggregates data from all plants in a production network, enabling multidimensional analysis spanning multiple plants, product lines and types of assets. International Informance, Inc., Redwood City, Calif. www.informance.com