By: Frank Corden is the Senior Director of Growth Services for New England Controls
Well it’s almost Halloween. So a story about data rising from the dead seemed an appropriate theme. Let’s start with a little background.
Data historians are a staple of the manufacturing control infrastructure at most, if not all, biotech manufacturing facilities. Whether provided as a component of the distributed control system (DCS) offered by Honeywell, Siemens, Emerson, or other DCS suppliers, or integrated as standalone software, such as offered by AspenTech, the historian is the go-to data source for the time-sequenced record of what has occurred on the manufacturing floor. When combined with an enterprise- or site-wide historian such as OSISoft’s PI Historian, the manufacturing data, the building control system data, and data from other selected sources can be combined in a single repository. Although these historians may be used in batch reporting, as well as for conducting investigations of process deviations, much of the data remains buried, unused, and unloved. As one of my colleagues put it, “they’re just data graveyards.”
Biotech manufacturers actively have been expanding their enterprise historians and adding capabilities using various data analytics software packages, including Biovia Discoverant, Dell Statistica, and Bio-G, to name a few. These systems enable manufacturers to integrate data sets not only from one or more data historians, but also from the Laboratory Information Management Systems (LIMS), the Enterprise Resource and Planning systems (ERP), the Learning Management Systems (LMS), the Product Lifecycle Management systems (PLM) and others. The objectives of the analytics system installation vary from company to company but there are common themes. These software systems enable more efficient and timely creation of reports, charts, and graphs to support: 1) routine generation of control charts and other process views, 2) operational excellence initiatives including but not limited to overall equipment effectiveness ( OEE), 3) investigations of process events, and 4) process development / tech transfer. In a few instances, the systems even come full circle with Quality by Design (QbD).
In the process development (PD) labs, the environment and the data challenge is very different from manufacturing. In any PD lab you can find a range of equipment from various manufacturers, all of which have control systems and collect data, but not many of these systems communicate with each other or to a central data repository. So in PD, the data lies buried in these islands.
Although the PD labs are comfortable with data analytics and use the tools routinely, the challenge lies in aggregating the data to make it available to them and extracting the data from these islands of automation.
To address this disparate data nightmare, one PD lab, has embarked on an ambitious program to integrate all their lab scale units to an OSI PI historian. By doing so, much more of the data is readily accessible without the manual transcription, creation, and distribution of spreadsheets that we often see in laboratories. One goal of the program is to enable the lab to generate their routine data analyses with greater automation and free their scientists to spend more time doing the experimental and analytics work they are trained for. By combining automated data aggregation with a historian and applying the newest analytics tools that also automate routine data analyses, we can liberate the data and bring to life the knowledge that is trapped within it. And that is a happy ending to our Halloween story.
About the Author: Frank Corden is the Senior Director of Growth Services for New England Controls, the leading supplier of process automation equipment and related services in the New England region. Frank has 20 years of experience in the Life Sciences industry. He has served as a Director for Decision Management International, PerkinElmer, and Emerson Process Management in operational, research and development as well as quality leadership roles. In his current position, Frank is responsible for managing an expanding team of engineers and technicians that deliver software products and services to industrial and life science customers throughout New England.
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