A rum deal for LIMS

When Bacardi needed to comply with new legal requirements by improving sample management, data recording and traceability – it turned to LIMS For a long time, the food and beverage industry has relied on manual processes and a paper-based system. The introduction of Food Safety Modernisation Act (FSMA) in the United States has brought about the need for greater scrutiny, which means that food and beverage producers around the world shipping product to the U.S. will have to think about how they manage their laboratory data with a view to compliance with U.S. regulations.  Food is global now, with choices available every day from food producers far removed from the consuming public. With the passing of the FSMA, food importers will be required to produce certificates of compliance to the new standards and ensure that accredited laboratories conduct proper testing. If certificates of compliance are not available to U.S. food inspectors, those food items will be refused entry to the United States.  These regulations and legislation are pressing companies to use a secure electronic data environment, increasing the need for laboratory information management systems (LIMS). Many food and beverage companies are wary of this change due to potentially high costs; however, the cost of recalling a product pales in comparison to a manufacturer’s worst nightmare: brand damage – and potentially losing the trust of consumers.

Bacardi, the largest privately held spirits company in the world, has to contend with various legal requirements implemented by the FDA. The major benefit to food and beverage companies resulting from the installation of a LIMS solution is improved operational efficiency. The LIMS provides companies with sample management, records data and test results, and ensures regulation compliance through increasing traceability. LIMS can also be integrated with other laboratory instrumentation systems and enterprise systems, enabling easier transmission of information across the lab and the organisation, reducing manual efforts and improving decision making.

A LIMS can highlight where time is being spent in sample processing and how the system can be improved. The Bacardi application example illustrates the LIMS system’s flexibility and improved efficiencies in the quality management of products.

As part of the food and beverage industry, Bacardi is one of many companies in the process of adjusting its sample testing and recording procedures to comply with the new legislation. Its flavoring center is in Geneva, Switzerland; in 2004, the laboratories within this site installed a Thermo Scientific LIMS with the aim of increasing operational efficiency throughout its testing facilities.

A project is in progress to roll out LIMS implementation across all Bacardi laboratories around the world, which will also be interfaced with SAP. LIMS provides Bacardi with effective sample management and recording of data, while increasing traceability of samples, ensuring full regulatory compliance. When LIMS is integrated with other laboratory instrumentation and enterprise systems, transmission of information across laboratories and the entire organisation is significantly enhanced. This allows for a considerable reduction in manual efforts within the laboratories and greatly improves the decision-making process.

At Bacardi, the LIMS plays a critical role in the traceability of quality in the production process, providing capabilities such as: •    Automated data collection from testing and delivering the records of proof that are required for regulatory compliance; •    A secure environment for monitoring batch relationships between raw materials, processed materials, and packaged goods; •    A centralized system that collects, stores, processes, and reports all the data generated within food laboratories, allowing a complete overview of the quality of any product; •    Automated checks for out-of specification results and identification of suspect products to prevent release pending investigation; and •    Assurance that all samples are handled and processed correctly.

Due to the increasing sophistication of technologies that detect contaminants and the resulting focus of legislative bodies around the world, the workload in food and beverage laboratories like Bacardi’s is increasing. As pathogens and potentially harmful contaminants are identified, analytical technologies are developed to enable detection and quantification. Regulatory authorities continuously update standards that compel laboratories to carry out these additional tests, and analytical techniques are evolving to give higher sensitivity to contaminants.

These points are illustrated with two facts: The FDA has reported that there are five times more identified pathogens than there were 50 years ago, and analytical technologies have advanced to allow large numbers of contaminants to be screened in a single method.

It is clear that modern analytical techniques have the ability to generate more and more data for the laboratory to process. It is also clear laboratory scientists need tools to enable them to spend as much time as possible doing important work, rather than manually sifting through data and preparing reports. The LIMS automates repeatable laboratory processes, allowing lab managers and scientists to better monitor the laboratory environment, as well as making critical information available as soon as it is processed.

Historically, data recording within the food and beverage industry has been a paper-based process. The newest food safety regulations are putting increasing pressure on companies to move away from a manual, paper-based system for many reasons, including traceability and accuracy of data.

Investing in a system that can effectively maintain their records means that companies need an automated system that can manage data and securely store results and reporting –functionality enabled by a LIMS.

Bacardi recognises the need for a shift away from a paper-based system. In fact, the company has identified that transition as its main challenge, striving to do as much reporting as possible in an electronic format –not always easy within a laboratory in which it is quite usual for the technicians to use paper. The LIMS is a vital component in helping Bacardi make the switch.

FDA legislation not only regulates the technical documentation required from food and beverage companies, but also indicates that all testing equipment must be maintained to a high standard. Additionally, some equipment must be set to a calibration percentage and needs to be frequently examined to ensure this does not falter. A reliable and consistent plan for the maintenance and calibration of equipment is therefore essential within laboratories, and a LIMS solution can provide this. The schedule of a laboratory is managed automatically and regularly by LIMS, and calibration of particular instruments on specific timetables can be included.

The testing facilities at Bacardi’s Geneva site largely process and analyse natural ingredients, including botanicals, extracts, and flavors. One of the key issues in these laboratories is, therefore, expiration of batches. To address this risk, a focus on quality is needed and a flexible LIMS solution is crucial. Moreover, the incoming sample volume continues to rise each year, and, with it, concern over efficiency of the testing process also grows.

“Due to the increasing sophistication of technologies that detect contaminants and the resulting focus of legislative bodies around the world, the workload in food and beverage laboratories like Bacardi’s is increasing”

With challenges and concerns such as these, which are found in most food and beverage laboratories, the functionality built into the LIMS can become invaluable to the efficient operations of the lab, along with the quality, sample, and document controls necessary to meet any regulatory requirements. A LIMS can record the time a sample arrives in the laboratory and the point at which it is validated, verifying every step of the process. This allows Bacardi to produce a monthly report, which calculates each step of the process, providing an indication of how time is being spent and highlighting areas of the process that could be improved upon. High efficiency can be provided whether the sample number is 10 or 10,000.

Typical food safety laboratories spend a large amount of time manually preparing reports. A LIMS allows lab managers to automate this time-consuming process using reusable templates, embedded calculations, and inbuilt instrument data management functionality. Automating the data collection process from instruments through calculations, all the way to the final result appearing upon a report, means that laboratory supervision is no longer required to validate each individual’s results, saving personnel time in collating and preparing manual reports.

First and foremost, the safety of food products is top priority for companies within the industry. Using a LIMS means that contaminated products are far less likely to be shipped out and reach consumers. Users of LIMS are rapidly alerted to any unexpected results within the testing procedure or to results that are out of tolerance. Therefore, along with food safety assurance, a LIMS can provide brand security by preventing scandals regarding contamination.

Portable, handheld computing devices are becoming more common in industries around the world, and laboratories are beginning to see the relevance of these devices, which can offer quick and secure access to data from any location, not just the physical laboratory. More and more laboratories are looking for technological support of mobile devices, and laboratory users are seeking the freedom to access data and LIMS functionality from anywhere within their laboratory –and beyond. LIMS-on-Demand and cloud computing functionality for such devices are predicted as the next big steps in LIMS technology.

International food and beverage companies require traceability within every step of the testing process. Reinforcement of the role of bar codes within this system is an important component of workflow for Bacardi, because bar codes can play a significant role in providing this traceability. Bar codes help to manage every sample that passes through the system, regardless of sequence.

LIMS are designed to cope with changes in laboratory workflows and customer infrastructure customisation. By developing systems that are user configurable, the approach allows the laboratory to cope with changes in methods, regulations, and customer demands.

The current political focus on food safety means that regulations are one of the most rapidly changing areas for the laboratory. For example, the FSMA places new demands on labs carrying out food testing for the U.S. market. New legal requirements for inspections, traceability, and certification mean that organizations need to be able to demonstrate complete control over their analytical process. Doing so without recourse to the built-in security, traceability, and control mechanism within the LIMS will be a challenging prospect.

LIMS solutions provide food and beverage companies with support throughout their laboratory procedures, from the input of raw ingredients to the packaging of the final products. Thermo Scientific LIMS deliver the automated process controls and workflow management essential to the quality of Bacardi products and allow the company to continue to build testing protocols and monitor results in a manner that meets regulatory requirements and ensures consumer satisfaction and safety. The LIMS provides a fully integrated laboratory platform covering a wide variety of requirements and regulations, including complete traceability of samples, quality control, monitoring, research and shelf life.

Authors:

Colin Thurston is director of product strategy for Thermo Fisher Scientific. Eduardo Granado is a quality assurance manager at Bacardi.