ISP Technologies in Texas City, Texas, is a manufacturing facility for specialty chemicals. With 200 employees and more than 300 chemical products for the personal care, pharmaceutical, agricultural, beverage and industrial industries, ISP's facility had a Texas-sized need for a LIMS.

As raw materials arrive at ISP, the laboratory tests them against plant specifications before they are released to the manufacturing area. Also, samples from other parts of the plant are routinely collected for analysis in the lab. Before the LIMS was installed, ISP technicians manually recorded the data into a large database, which resulted in problems with data transfer, storage and retrieval.

ISP needed to move from its manual system with multiple data entry points to an integrated LIMS. The goal for the new system was clear: to improve information quality and customer service while increasing productivity.

LIMS Requirements

After careful analysis, ISP required the new LIMS to:

• Increase and preserve data integrity by having a single source for data entry points.
• Support in-bound and out-bound materials testing.
• Support testing of in-process samples.
• Enable process engineers to compare historical data with current data for trend analysis.
• Have an easy-to-use interface so users could quickly collect information and display it graphically to identify out-of-control situations.
• Allow employees to analyze a situation quickly.
• Quickly provide professional looking, easy-to-understand customer reports.

A key piece of the new LIMS would be a statistical process control (SPC) charting system that would make it easy to generate high quality control charts and other graphics for displaying data.

Software Selection

After a rigorous selection process that included consulting with experts and other LIMS users, as well as reviewing demos, ISP chose LabManager™ from Beckman Coulter (Allendale, NJ). A key factor in the selection was LabManager's strong Strategic Directories International (SDI) rating for pharmaceutical products subject to FDA regulation.

But ISP wanted a more comprehensive graphical capability than the standard one provided with LabManager. Rather than disqualify a package that otherwise met their needs, they asked Beckman what could be done.

Beckman recommended an add-on module of NWA Quality Analyst from Northwest Analytical (Portland, OR) for which they had designed an interface to LabManager. The superior graphical and statistical charting capabilities of NWA Quality Analyst would provide what ISP needed.

Implementation

Control room operators access both the LIMS and the Quality Analyst.

Implementation began in July 1997, and the LIMS became fully operational approximately six months later. Currently all 200 ISP Technologies employees have access to LabManager. The NWA Quality Analyst interface is primarily used by supervisory personnel in the laboratories and in engineering.

Because NWA Quality Analyst requires minimal training to use, ISP's training resources have focused on LabManager. Training is ongoing as more and more employees learn to use the system and as new modules get added. ISP makes training available for users who want to do more sophisticated tasks as they get more familiar with the system.

System Features

The new LIMS is used widely by employees in all areas of the company. Most technicians use it for data gathering, storage and retrieval. ISP's process engineers use the system as a desktop application to analyze trends, prepare reports for customers and examine processes.

The system offers substantial gains in terms of convenience and automation of information gathering. For incoming materials, lab technicians conduct tests and record results in the LIMS, which automatically compares them to plant specifications. An approval is issued by the LIMS when all specifications are met.

For routine sampling, samples from different parts of the plant are collected for analysis in the lab. Lab technicians enter the results into the LIMS, which reports to the appropriate control rooms around the plant. Control room operators can access the LIMS through their PCs and view the status and results in real time. They also can access NWA Quality Analyst and view the trend of a particular sampling point as a one-button operation.

With NWA Quality Analyst, ISP sets up icons that are specifically relevant for certain positions in the plant. The employee simply clicks on the icon to launch a routine task or report. Occasional input is needed (such as a time range) and the system automatically prompts the employee to input the information before performing the automated task.

Fulfilling customer requests for information is an important function of the new LIMS. The system allows employees to do this quickly by faxing reports to customers right from their desktops shortly after the customer calls. This has shaved large amounts of time off the process from the pre-LIMS procedure of searching the data and laboriously preparing a report.

Conclusion

For ISP Technologies, the new LIMS has been an unqualified success, automating many routine SPC tasks, improving data quality and allowing rapid response to customer requests for information. In part, ISP attributes this success to the flexibility gained by interfacing two off-the-shelf software packages.

Tamara Hudson is a writer based in Portland, OR. She can be reached at Tel: 503-796-0350, E-mail: tamara@greenleafpr.com.

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