A leading manufacturer of tablets, softgels, and two-piece hard-shells in the nutraceuticals and personal health enhancement market, like other players in the industry, faced the challenge of meeting tougher quality standards while reducing costs to meet the challenge of global competitors. An important element in the company’s success was its adoption of the latest laboratory information management system (LIMS) technology. That move eliminated much of the paperwork previously required to be performed by analysts, making it possible for 50% more tests to be performed, while the number of analysts had been reduced by 25% through attrition and movement to other positions in the organization. Also, automatic entry and movement of data have greatly reduced the potential for data entry and transcription errors.
Nutra Manufacturing, Inc. produces 1300 different product codes and uses a roughly equal number of raw materials. A typical product run lasts 3–5 days. The company has two facilities, a manufacturing plant in Greenville, SC, and a packaging and raw materials storage facility 30 miles away in Anderson, SC. Analysts perform a battery of tests to ensure the identity and potency of raw materials, in-process materials, and finished products using instruments such as HPLCs, GCs, UV spectrometers, inductively coupled plasma mass spectrometers (ICP-MS), and Fourier transform infrared spectrometers (FTIR). The company has demonstrated capacity of 150 million bottles per year when operating 5 days per week, 24 hours per day.
Previous paper-based processes
In the past, the laboratory used paper forms to track the flow of work through the quality control laboratory and also to manage analysis results. Operators collected samples, filled in the labels by hand, and dropped them off at the laboratory. Analysts were responsible for locating the samples in their area of responsibility and performing the analysis. They would then write out the results on paper forms. These forms were routed manually through the laboratory to obtain the required three levels of approval. The results were then typed into a spreadsheet that was used to prepare necessary reports for customers, regulatory agencies, and management.
The problem with managing laboratory data on paper was that a considerable portion of analysts’ time was tied up performing data entry and transcription work that detracted from their productivity. Beyond that, the analysts spent far too much time looking for samples, figuring out what they needed to do, making entries in paper logbooks, and manually preparing reports.
In the past, the manual movement of samples and forms and the manual entry of data created the potential for errors. Many check levels were required to avoid the possibility of a sample being overlooked and not tested or a number being typed incorrectly into a report. One of the major goals in moving to LIMS was to improve efficiency while exceeding the company’s previous high level of quality assurance.
Selection and implementation of LIMS
The key requirement in the LIMS search was to find a system with the flexibility to handle a broad range of products and methods. It can be said that the most consistent thing about the company is its inconsistency: It manufactures many different products with many different requirements, thus necessitating a very large number of methods to meet the needs of its customers and ensure the safety of the users of its products. A number of different LIMS were under consideration, but LABWORKS (PerkinElmer, Shelton, CT) was ultimately selected because the system’s flexibility matches that of the company’s. The software can handle a wide range of tasks with considerably less customization than other packages considered. Also desirable was the interface developed by PerkinElmer from the LABWORKS system to Stability Laboratory Information Manager (SLIM) (H&A Scientific, Inc., Greenville, NC), the tool the company uses for managing its stability study protocols.
PerkinElmer consultants worked closely with the author and other Nutra managers in customizing the user interface to handle the company’s complete range of data management requirements. The implementation process included development of electronic fill-in-the-blanks templates for every method. Instead of writing out each step in the test in a paper notebook, analysts simply type in a few key pieces of information to indicate that they have followed the appropriate method. The software automatically generates labels for each of the tests required for every batch of raw and intermediate material and finished product. The labels are affixed to each sample and also serve to remind the operators which samples need to be collected. This helps eliminate the possibility of skipping a test and saves a large amount of time. Analysts now simply scan the label to enter all of the information required about the test except for the results (Figure 1).
Figure 1 - The customizable process scheduler can be filtered and sorted any way the analyst desires.
The implementation process also included creation of a work flow that manages the movement of data involved in approvals at the sample, test, and product level. As soon as the test is completed, the test results move into the inbox of the person who is responsible for the first level of approval. As each level of approval is completed, the results move to the inbox of the person responsible for the next level. Finally, when all the approvals have been completed, the software makes available the results to other departments for final product release. Managers can easily generate reports detailing which samples are ready to collect, ready for analysis, waiting for approval, etc. This makes it easy to evaluate the workload and backlog of the laboratory and identify and correct bottlenecks before they have a major impact (Figure 2).
Figure 2 - This screen shows only the products ready for production release in the process scheduler.
Advantages of SLIM interface
Figure 3 - A custom report substitutes the label claim for results that were not actually run and indicates the results were merely input.
SLIM tracks all of the information needed to schedule and manage stability studies and calculate the results based on analytical testing. When the interface between LABWORKS and SLIM is completed, it will save time and improve accuracy by automating the process of transferring analytical testing results from the various instruments to SLIM, as well as the movement of stability testing data back into LABWORKS, where it will be available for inclusion in reports (Figure 3).
Figure 4 - The historical results for any test on any product can be reviewed while in the results entry section.
The LIMS has greatly improved the efficiency of the quality control laboratory. Simply eliminating the need to fill out paper forms for every test has saved approx. 25% of the analysts’ time. Prior to implementing the LIMS, the company had 16 analysts handling a workload of approx. 10,000 assays per month. Today, due to higher volume and increased quality standards, only 12 analysts are performing 14,000–16,000 assays per month. The only major change in the laboratory over that period was the implementation of the LIMS; it is clear that LABWORKS is responsible for the vast majority, if not all, of the improvement (Figure 4).
Financial benefits from reducing turnaround time
Eliminating most of the paperwork in the laboratory had an additional measurable financial impact by reducing turnaround time. In the past, it took an average of 10 days from the time production was completed and the last tests had been performed for the product to be ready to ship to the customer. Today, all product testing can be completed in an average of 7 days.
Conclusion
It is difficult to envision how the company’s laboratory staff would have functioned in an increasingly demanding environment without the new LIMS. It has enabled the management of a larger workload with a smaller staff, while concurrently reducing turnaround time. Analysts are able to spend less time on paperwork and more time utilizing their core skills. It is also important to note that these benefits were achieved before the implementation process was fully completed. A number of important steps still need to be taken, including completing the LABWORKS/SLIM interface, interfacing to the company’s chromatography software, and automatic sample log-in from its raw materials management software. It will be very interesting to see the company’s progress a year from now.
Ms. Vaughn is Quality Control Manager, Nutra Manufacturing, Inc., 1050 Woodruff Rd., Greenville, SC 29607, U.S.A.; tel.: 864-987-3531; fax: 864-987-4202; e-mail: [email protected].