How One LC Column Manufacturer Used a Scientific Data Management System to Decrease Operational Costs and Accelerate Product Delivery

Liquid chromatography (LC) is among the most common techniques found in analytical laboratories today. High-performance liquid chromatography (HPLC) and ultra-performance liquid chromatography (UPLC®) systems are routinely used for discovery, development, and quality-control applications in the chemical, pharmaceutical, and food and beverage industries, among others. For organizations operating in these market areas, delivering quality, consistent products is partially dependent upon the ability of their laboratories to generate quality, consistent LC data. Whether their concern is meeting regulatory standards, brand protection, or ensuring product efficacy and composition, companies must be certain that the chromatography technologies (hardware, software, and columns) employed are never a source of variability in sample characterization data. Should the manufacturers of these technologies fail to supply products with performance that is highly reproducible, their customers could face serious economic and legal ramifications.

This article describes the use of a scientific data management system (SDMS) by an LC column manufacturer to produce consistently performing products for customers under intense regulatory and competitive pressures.

Total control for consistent performance

Waters Corporation, headquartered in Milford, MA, produces more than 30 different brands of chromatography columns. With each brand comprising a variety of particle sizes, degrees of porosity, and chemical modifications, the company supplies literally hundreds of product types to its customers. Two of Waters’ sites— Taunton, MA and Wexford, Ireland—work collaboratively to produce the final product. The many varieties of chromatographic media are generated at the Taunton fine chemical plant, then sent to Wexford, where the columns are packed and shipped to customers around the world.

Critically important is Waters’ ability to guarantee that a column delivered today performs identically to a column delivered last month, last year, or last decade. To achieve this, Waters tightly controls every step of the manufacturing process, including raw material modifications, in-process testing, and final product quality control, as well as supplying the actual column hardware (produced at the Milford facility). For Waters to exert this level of comprehensive control, the company must continuously acquire, process, interpret, and disseminate vast quantities of analytical data. If not addressed adequately, data management on this scale has the potential to create a bottleneck, negatively affecting production efficiency and customer satisfaction.

To help maximize the value of scientific information, and to ensure that it is a fully leveraged asset rather than a liability, the Taunton and Wexford sites implemented a scientific data management system (SDMS) platform that is marketed by Waters’ software business division (see Figure 1). The SDMS platform collects data from a wide variety of sources, including instruments (from different vendors and utilizing different technologies) and analysts. This information is automatically indexed and archived within a centralized data warehouse, where it can be searched and shared across departments or different geographic locations.

Critical manufacturing support from analytical laboratory

The synthesis of chromatographic media at the Taunton site is a multistep process that can take from four to six months. The raw silica, polymer, and hybrid particles are synthesized, then subjected to pore modification, sizing, and bonding steps. The facility produces about 150 batches each month, with 30 to 40 tests performed per batch by an in-house analytical laboratory. The lab utilizes 14 instrument types and operates dozens of systems in total; techniques include UPLC®, HPLC, GC, mass spectrometry, TGA, microscopy, and ICP, among others. All the data generated are collected by the SDMS (via its print-to-database functionality, which captures the actual content of instrument-generated reports) and used for inprocess product characterization, for determination of final media quality, and in long-term trend analyses. The SDMS allows lab analysts not only to process and report these results more rapidly, but to access information more readily. There are numerous benefits to enhancing the laboratory’s data management capabilities for manufacturing:

• More agile decision making
• Greater control of synthesis processes
• Lower risk of batch failures, which are costly and waste months of manufacturing time
• Superior batch-to-batch reproducibility
• Clearer understanding of existing processes, which allows for modifications that increase speed, lower costs, and improve overall product quality

Streamlining quality control and customer support

Once supplied with column hardware and media from the United States, the Waters Wexford site produces thousands of units per week. A critical step in the column manufacturing process is the review of outgoing customer orders prior to packaging and shipping. The reviewer’s primary responsibility is to inspect product quality and associated paperwork. Reviewers are also required to manually enter data for 14 categories of column detail information: efficiency, back pressure, retention time, batch number, part number, serial number, etc. In total, 56,000 manually transcribed entries are made per week—a laborious, time-consuming process. In addition, all column detail data are archived on DVDs. Accessing this information for customer inquiries regarding products in use may require up to two hours of the analyst’s time, potentially reducing productivity and increasing response time.

In an effort to streamline their quality control and customer support activities, the Wexford facility implemented the SDMS platform. In the Wexford application, SDMS interacts with chromatography software via its print-to-database functionality—as reviewers print column test chromatograms, SDMS automatically catalogs the pertinent information and saves it to the database. Information on the column, including a hyperlink to the corresponding chromatogram, can be instantly retrieved at any time from multiple geographic locations.

Since implementation of the SDMS, the Wexford facility has noted several improvements in its order fulfillment workflow:

• The automatic capture of column detail information with SDMS has reduced the data entry error rate to nearly zero. During the print-to-database operation, a template ensures that all relevant indexing information is captured for each chromatogram, thus providing automated error-proofing.
• The time for a reviewer to input product data for one 96-piece customer order has been reduced by 50 percent.
• With less time required for data entry, reviewers are able to focus more time on quality improvements.
• Electronic storage of column performance records means that data can be easily shared between the Taunton and Wexford facilities on a 24/7 basis.
• By entering a particular serial number into the SDMS, an analyst has instant access to archived column quality control data. Customer inquiries on column performance can be addressed immediately, which helps minimize disruptions to the customer’s workflow.

The future: Improving workflow with an electronic laboratory notebook

To further streamline the analytical workflow in the Taunton facility, Waters is in the process of implementing the electronic laboratory notebook (ELN) capability of the SDMS platform (see Figure 2). The ELN serves as a portal into laboratory databases, allowing analysts to automatically import captured information from the SDMS repository as well as content managed by other software solutions.

For the Taunton application, automated quality control calculations to identify “out-of-guidelines” samples are being performed on imported testing data acquired during production. Although it’s still in the preliminary stages, results of the ELN deployment are very encouraging. By migrating what have been historically manual activities to a fully electronic format, the laboratory is able to eliminate transcription errors, accelerate data review, improve decision making, and reduce paper usage. Additionally, the future business implications of the combined SDMS/ELN solution for the Taunton plant could be substantial, given the potential to decrease operational costs and accelerate product delivery.