Chemical manufacturing companies today must be more adaptable than ever. This is especially true in the production of fine and specialty chemicals, where some manufacturers 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 adaptable to revenue-generating opportunity without compromising quality.
Process changeover in the chemical manufacturing industry
While all chemical manufacturers, including those that produce commodity chemicals, are concerned with batch quality and consistency, manufacturers of fine or specialty chemicals must also manage multiproduct environments. Changing raw materials, varying processes and conditions, and implementing different reporting requirements 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 recalibration and/or replacement or reorganization of staff. Manufacturers cannot afford mistakes during changeover. The costs are high—an error that allows an out-of-spec product to reach a pharmaceutical customer may be the last order that specialty manufacturer ever receives.
In such a dynamic production environment, laboratories must be flexible. Each batch change necessitates that the laboratory take critical steps, such as deploying specific analytical instruments and capturing 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 composition, testing requirements, and even individual contracts with customers. Even as instrument manufacturers offer increased instrument flexibility, such as a single system that can be upgraded from a simple benchtop FTIR to a fully automated, multispectral 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 process characteristics for centralized data and work flow management can ensure that.
Managing this complexity is not just challenging; it is truly mission-critical. While production flexibility is important, no sacrifices in quality can be tolerated, nor can there be delays in the changeover process, with a competitive environment placing premiums on higher throughput and faster delivery. This is where a LIMS shows its greatest value, i.e., automating such aspects of the changeover as instrument recalibration, thoroughly preparing the manufacturer for the next batch, and facilitating the batch release process by making decision data available the instant they are approved.
Use of laboratory information management systems in the specialty chemical industry
In the highly competitive specialty chemical industry, LIMS is not simply an operating 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 continuous business transformation. Bayer, a leading chemical manufacturer based in Leverkusen, Germany, is proof that integration, innovation, automation, and business intelligence, enabled by LIMS, are key drivers for business success.
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.
Bayer manages a highly complex operation, with multiple sampling laboratories providing important business data that are used across the enterprise. The company handles this significant volume and velocity with Thermo Scientific Sample Manager LIMS (Thermo Fisher Scientific, Philadelphia, PA), integrating instruments with enterprise systems to ensure quality, consistency, and compliance (see Figure 1). Sample Manager LIMS is an enterprise-level informatics solution enabling connectivity of the laboratory with existing systems across the organization, which will help Bayer develop products that are safe while using the most sustainable processes, and at the same time delivering value to its shareholders.
Figure 2 – Standard dashboards provide graphical representation of laboratory data.
SampleManager LIMS provides a comprehensive outlook of laboratory operations, performance, and productivity. Advanced dashboard 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 interfaces, 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.
Figure 3 – With SampleManager LIMS, data can be displayed pictorially, giving a rapid indication of critical process parameters.
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 automated 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 produced by each instrument. This integration gives Bayer the flexibility in scheduling, materials management, work flow, and production that is so important in specialty chemical manufacturing.
Laboratory information management systems and renewable chemicals
Plant-based materials, commonly called renewable chemicals or biobased chemicals, are a rapidly growing segment of the marketplace. They also illustrate the challenges faced by laboratories that do not have an efficient laboratory information management system in place.
Coca-Cola (Atlanta, GA) is a leader in using renewable plastics. In fact, the company recently announced the ambitious goal of using 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. For example, researchers have discovered a way to produce isoprene (a component of a specialty rubber) from cellulose. Isoprene is currently 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 present 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 chemical processes.
Flexibility in raw materials enables chemical manufacturers to transform their operations into successful businesses, unencumbered by concerns that new materials could disrupt or corrupt processes. The LIMS is central to this, not only by comparing each batch’s performance to previous batches to ensure long-term quality control and innovation, but also by ensuring that instruments are properly calibrated and maintained, that product quality is assured, and that production is in full compliance.
Additional challenges for chemical manufacturers
Sustainable materials are not the only change sweeping the chemical industry; new, more stringent regulations are now in place that impact testing and reporting requirements for all chemical manufacturers. The European Union Regulation, REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals), has already transformed the global chemical industry. Its influence is far-reaching, not only because roughly one-third of the world’s chemicals 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 under 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 spectroscopy platforms. With this comes the challenge of effectively managing 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 automation to reduce manual procedures. By freeing up laboratory managers from paper-based systems, productivity can be greatly improved, and the resulting effect on margins and revenue can be significant. A LIMS is critical to the realization of a truly paperless lab.
Increasing flexibility in the chemical industry
Today’s chemical manufacturers face a more onerous regulatory environment and greater demand from their customers to produce higher-quality products Companies like Bayer assiduously monitor 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 products; to do this, they must have systems in place that allow for rapid turnover, changing work flows and materials management, and sophisticated 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 opportunities 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: firstname.lastname@example.org.