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Achieving Success in Chemical Manufacturing: How a Laboratory Information Management System (LIMS) Ensures Flexibility in the Lab

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January 2013 Volume 45, Number 1

Chemical manufacturing compa-nies today must be more adapt-able than ever. This is especially true in the production of fine

and specialty chemicals, where some man-ufacturers change over production lines weekly or even daily. Within these highly flexible manufacturing environments, the laboratories that ensure the quality, safety, and efficacy of chemical products must be equally flexible. This is no easy task due to stringent controls on the composition and quality of finished product. This article examines how a laboratory information management system (LIMS) can enable chemical manufacturing labs, and external labs serving the industry, to be more adapt-able to revenue-generating opportunity without compromising quality.

Process changeover in the chemical manufacturing industryWhile all chemical manufacturers, includ-ing those that produce commodity chemi-cals, are concerned with batch quality and consistency, manufacturers of fine or spe-cialty chemicals must also manage multi-product environments. Changing raw mate-rials, varying processes and conditions, and implementing different reporting require-ments create opportunities for error and revenue/product loss that are less likely to occur in continuous process environments.

Although common, changeover is complex because it can involve equipment recalibra-tion and/or replacement or reorganiza-tion of staff. Manufacturers cannot afford

Achieving Success in Chemical Manufacturing: How a Laboratory Information Management System (LIMS) Ensures Flexibility in the Lab

Chemistry

mistakes during changeover. The costs are high—an error that allows an out-of-spec product to reach a pharmaceutical cus-tomer may be the last order that specialty manufacturer ever receives.

In such a dynamic production environ-ment, laboratories must be flexible. Each batch change necessitates that the labora-tory take critical steps, such as deploying specific analytical instruments and captur-ing unique data. One day a QA/QC lab may be using a chromatography system or mass spectrometer, and the next it could be near-infrared (NIR). Testing requirements will vary based on product type and com-position, testing requirements, and even in-dividual contracts with customers. Even as instrument manufacturers offer increased instrument flexibility, such as a single sys-tem that can be upgraded from a simple benchtop FTIR to a fully automated, multi-spectral range system that acquires spectra from the far- to the near-infrared without manually changing system components, holistic process and data integrity—beyond any one instrument—are still critical, and a LIMS that integrates instruments and pro-cess characteristics for centralized data and work flow management can ensure that.

Managing this complexity is not just chal-lenging; it is truly mission-critical. While production flexibility is important, no sac-rifices in quality can be tolerated, nor can there be delays in the changeover process, with a competitive environment placing pre-miums on higher throughput and faster de-livery. This is where a LIMS shows its great-est value, i.e., automating such aspects of the changeover as instrument recalibration,

thoroughly preparing the manufacturer for the next batch, and facilitating the batch re-lease process by making decision data avail-able the instant they are approved.

Use of laboratory information management systems in the specialty chemical industryIn the highly competitive specialty chemi-cal industry, LIMS is not simply an op-erating system for the laboratory; it is also an essential means of integrating the laboratory’s output with other enterprise systems, giving management access to key business metrics across the organization and presenting opportunities for con-tinuous business transformation. Bayer, a leading chemical manufacturer based in Leverkusen, Germany, is proof that inte-gration, innovation, automation, and busi-ness intelligence, enabled by LIMS, are key drivers for business success.

Bayer manages a highly complex opera-tion, with multiple sampling laboratories providing important business data that are used across the enterprise. The company handles this significant volume and veloc-ity with Thermo Scientific SampleManager LIMS (Thermo Fisher Scientific, Phila-delphia, PA), integrating instruments with enterprise systems to ensure quality, consistency, and compliance (see Figure 1). SampleManager LIMS is an enterprise-level informatics solution enabling connectiv-ity of the laboratory with existing systems across the organization, which will help Bayer develop products that are safe while

by Colin Thurston

AMERICAN LABORATORY • 1 • JANUARY 2013

Reprinted from American Laboratory January 2013

AMERICAN LABORATORY • 2 • JANUARY 2013

marketplace. They also illustrate the challenges faced by laborato-ries that do not have an efficient laboratory information manage-ment system in place.

Coca-Cola (Atlanta, GA) is a leader in using renewable plastics. In fact, the company recently announced the ambitious goal of us-ing PlantBottle packaging for its entire virgin PET supply by 2020. To accomplish this project, Coca-Cola turned to biotech firms that demonstrated an ability to deliver consistent quality to exacting specifications. Although there is tremendous opportunity in plant-based materials, there are challenges as well.

Plant-based materials are often regarded as “drop-ins,” or substitutes, for a variety of manufacturing processes, but it is not that simple.

using the most sustainable processes, and at the same time deliver-ing value to its shareholders.

SampleManager LIMS provides a comprehensive outlook of labo-ratory operations, performance, and productivity. Advanced dash-board capabilities (see Figures 2 and 3) permit faster, more informed decision-making by enabling technicians and managers to provide at-a-glance views into everything from instrument calibration to maintenance and service schedules. Through customized user in-terfaces, configured to provide specific information for specific job functions, one team member can confirm compliance with standard operating procedures while another can use information for prototyping, a critical benefit that improves business decision- making, reduces costs, and increases revenue opportunity.

Bayer is taking this implementation to the next level by ensuring that the LIMS is fully integrated with all instrumentation across its laboratories. By using Thermo Scientific Integration Manager, a flexible and powerful data transformation tool that delivers auto-mated data acquisition and point-to-point data distribution across the enterprise, data can be collected electronically and stored in a central database, regardless of the individual output formats pro-duced by each instrument. This integration gives Bayer the flex-ibility in scheduling, materials management, work flow, and pro-duction that is so important in specialty chemical manufacturing.

Laboratory information management systems and renewable chemicalsPlant-based materials, commonly called renewable chemicals or biobased chemicals, are a rapidly growing segment of the

Figure 1 – SampleManager LIMS enables enterprise-level integration, connecting the lab with process information management systems (PIMS), manufacturing execution systems (MES), and enterprise resource planning (ERP) systems.

Figure 2 – Standard dashboards provide graphical representation of laboratory data.

Figure 3 – With SampleManager LIMS, data can be displayed pictorially, giving a rapid indication of critical process parameters.

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For example, researchers have discovered a way to produce isoprene (a component of a specialty rubber) from cellulose. Isoprene is cur-rently extracted from petroleum at a volume of more than 700,000 tons per year. With this new supply source—as with many other plant-based chemicals—there are added risks and responsibilities during the manufacturing process, mostly water related.

Many production challenges, however, can be overcome by LIMS. Laboratory personnel can customize instrument calibration and maintenance protocols to accommodate the water content pres-ent in plant-based chemical feedstock. Constant monitoring and reporting and preconfigured automation mitigate risk and pave the way for strategically introducing new materials into specialty chemi-cal processes.

Flexibility in raw materials enables chemical manufacturers to transform their operations into successful businesses, unencum-bered by concerns that new materials could disrupt or corrupt pro-cesses. The LIMS is central to this, not only by comparing each batch’s performance to previous batches to ensure long-term qual-ity control and innovation, but also by ensuring that instruments are properly calibrated and maintained, that product quality is as-sured, and that production is in full compliance.

Additional challenges for chemical manufacturersSustainable materials are not the only change sweeping the chemi-cal industry; new, more stringent regulations are now in place that impact testing and reporting requirements for all chemical manu-facturers. The European Union Regulation, REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals), has al-ready transformed the global chemical industry. Its influence is far-reaching, not only because roughly one-third of the world’s chemi-cals are produced in Europe, but also because chemicals imported into Europe must comply as well.

As new REACH requirements are phased in, manufacturers must adjust to the regime. Previously, laboratories were not required to routinely perform hazards-based analysis, but this is mandatory un-der the new regulation. REACH places greater responsibility on industry to manage the risks from chemicals and provide safety information on substances. Manufacturers must collect data on the properties of their chemicals and register that information in a

central database run by the European Chemicals Agency (ECHA) in Helsinki, Finland.

With such broad-reaching regulations, manufacturers increasingly require new analytical instruments, including handheld devices and advanced chromatography, mass spectrometry, and spectros-copy platforms. With this comes the challenge of effectively man-aging the instruments and the data they generate. Because the chemical manufacturing process involves significant complexity, from unique customer specifications to plant safety and regulatory issues, efficient management of the process requires extensive au-tomation to reduce manual procedures. By freeing up laboratory managers from paper-based systems, productivity can be greatly im-proved, and the resulting effect on margins and revenue can be sig-nificant. A LIMS is critical to the realization of a truly paperless lab.

Increasing flexibility in the chemical industryToday’s chemical manufacturers face a more onerous regulatory environment and greater demand from their customers to produce higher-quality products. Companies like Bayer assiduously moni-tor quality and performance, and are poised to capitalize on every opportunity to transform their business. Chemical manufacturers must be prepared to produce a range of customer-specified prod-ucts; to do this, they must have systems in place that allow for rapid turnover, changing work flows and materials management, and so-phisticated data management.

If one word could define opportunity in the chemical industry it would be “flexibility.” It follows, then, that laboratories serving this industry should strive for as much flexibility as possible. In the chemical manufacturing lab, LIMS is not just the first step; it is the most important step toward achieving the agility required to meet precise customer demands and stringent regulations. Once in place, the business will not simply capture and collect data; it will make those data actionable across the enterprise. While ensuring this system flexibility, the LIMS will also enable management to respond more quickly to market trends or new regulations, and recognize and capitalize on cost-saving or margin-growing opportu-nities in the future.

Colin Thurston is Director of Product Strategy, Process Industries, Thermo Fisher Scientific, 1601 Cherry St., Philadelphia, PA 19102, U.S.A.; e-mail: colin.thurston@thermofisher.com.

CHEMICAL MANUFACTURING continued