LIMS Vital in Food SafetyLIMS helps food producers and importers to comply with U.S. legislation regulations and to ensure product quality.by Colin Thurston, Director of Product Strategy, Process Industries, Thermo Fisher Scientific
The FDA issued a number of regulations to ensure the safety of food manufactured, distributed, exported and imported in the U.S. | To ensure product quality and compliance with food safety legislation, U.S. food producers and importers must perform precise, real-time product testing at all stages of production, processing and distribution. LIMS, thus, play a vital role in the food sector as they form the basis of data collection and analysis and the integration of the instrumentation and other enterprise systems in use in major food producing companies.
Food safety legislation
In recent years, food safety incidents in the U.S. have been increasing at a fast pace, such as the peanut butter scare and contaminated meat products. These events have generated strong public concern about the safety of the foods they consume and which companies are utilizing the most stringent safety practices in the preparation of food items.
Major food producers importing and exporting between the U.S. and Europe are guided by the U.S. Food and Drug Administration (FDA) and the European Food Law. The FDA issued a number of regulations to ensure the safety of food manufactured, distributed, exported and imported in the U.S. The Federal Food, Drug and Cosmetic Act (FDCA) prohibits the adulteration or misbranding of any food, drug, device or cosmetic intended for interstate commerce.
Food testing must address the complete spectrum of safety issues, including veterinary drug residues, pesticides, natural toxin such as mycotoxins and marine biotoxins, pathogens, trace elements, and chemical residues such as environmental pollutants.
With U.S. food imports projected to total $6 trillion by 2015, consumers are faced with even greater safety challenges. In response, the FDA has introduced the Import Safety Action Plan to establish a stronger certification process, provide incentives to encourage good importer practices, increase transparency by publishing the names of certified producers and importers, and strengthen penalties for both foreign and domestic entities.
Regulatory guidelines are becoming more exacting in both the U.S. and Europe. For example, the proposed U.S. Food Safety Enhancement Act would require every food producer to register with the FDA (at a fee of $1000 per annum); the FDA will levy inspection fees if they need to investigate an incident, and there will be legal product traceability requirements. The FDA will also be able to mandate food recalls by producers and inspect all food-related records (paper and electronic). Under these new regulations, non-cooperation by any food producer will result in “adulterated” products.
A robust LIMS can greatly augment this by providing these companies with a means to capture the data necessary to prove compliance and to inform management of deviations in the quality of their output, so proactive steps may be taken to protect the consumer and their company’s productivity.
The role of LIMS
Data management solutions are used in a variety of ways in the food and beverage market; but in general terms, laboratory data is captured to prove the safety, traceability and regulatory compliance of food and beverages provided to consumers.
Key areas of concern for food manufacturers are sample tracking, result capture and analysis, and reporting. To monitor product quality, effectively manage any recalls, and limit product loss batch, traceability is key.
LIMS solutions can efficiently manage batch relationships between raw materials, processed materials, and packaged goods, enabling analysts to identify which batches are affected by any contamination and automatically suspend release of a product during investigation. The LIMS workflow automatically schedules an analytical review for samples with positive results, addressing the need for fast screening techniques to identify potential contaminants.
LIMS manage and control the quality assurance process, organize and store analytical data, and facilitate the conversion of data to information. LIMS automatically capture sample data, check for out-of-specification results, and assemble data for submission to the FDA.
The food and beverage market is recognizing that, in the current regulatory market, maintaining consumer safety is not possible without modern data management tools.
Data handling
Food analysis techniques produce large quantities of different types of data. LIMS can automatically gather, store, manage and report on these data, including sample preparation data, instrument-generated data, standards, reagents and media, reference data for users and management, and metric reports.
Notes can be used to attach SOP documents to instruments and operators within the LIMS, while links to external repositories and Web sites can also be configured. Certificates are stored within the LIMS for traceability and re-issue while templates are used to generate consistent formats of analytical reports.
Laboratory automation is one the most important benefits associated with the use of LIMS. Laboratory analysts can avoid any transcription errors associated with manual data management techniques, eliminating data overlaps and lost man hours. LIMS can also track instrument status, identify any requirements for calibration and/or service, and report on the specific parts needing replacement.
Maximizing efficiency
Using LIMS in the food safety workflow ensures samples are handled correctly and processed within allocated timeframes. This is imperative as food samples used for safety testing are often time and condition sensitive, requiring fast turnaround or storage in suitable conditions. LIMS can identify each sample; uniquely generate labels, barcodes and hazard data; and store metadata and sample lifecycle transactions.
Seamless integration
In large organizations, a LIMS plays a key role in integrating the laboratory environment with enterprise resource planning (ERP) and other critical systems. This allows laboratory test data to be available to plant process and control systems, giving managers immediate access to results.
Müller UK’s LIMS assists with real-time monitoring of production processes and plays a pivotal role in ensuring quality control for the finished product. | Application example
Molkerei Alois Müller (UK) produces more than a third of all yogurt eaten in the UK from the Market Drayton factory. The Müller UK labs focus mainly on production QC. Milk from farms arrives by tanker, pass by pumps into silos, and are then separated into skim milk and cream, and some skim into concentrate.
Yogurt mixes are made in tanks and batch sterilized. If the batch meets specifications, it is processed through a heat exchanger, cooled, and placed in an incubation tank where culture is added.
Every step in the process undergoes quality checks. During incubation, the pH is monitored and checked every 2 hours. After 8 to 9 hours of incubation, the pH has dropped and a final pH check is made when the yogurt is cooled. Previously, every check was performed and recorded manually; however, increased production led to the implementation of a LIMS, which was justified by the need to increase the lab’s efficiency.
Müller UK selected the Thermo Scientific Nautilus LIMS to manage QC data for raw materials, in process, and finished dairy desserts. The LIMS reduced the amount of error-prone paperwork and expedited testing. It also assists with real-time monitoring of Müller’s production processes and plays a pivotal role in ensuring quality control for finished product.
By using a LIMS, Müller is able to trend all data and make decisions and necessary improvements much faster. Implementing a LIMS has helped Müller UK’s lab to not only meet production demands with equanimity but will also position them to meet future challenges.
Conclusion
U.S. regulatory bodies introduced strict regulations to ensure all food produced, sold, imported and exported in the U.S. does not pose any health risk to consumers.
To comply with these regulations, companies in the food industry need a powerful LIMS to facilitate batch traceability, automatic collection, storage, analysis and reporting of results, and seamless integration of instrumentation and enterprise systems. Tracing processes in the food manufacturing and supply chain is a critical function in ensuring product quality and regulatory compliance.
A LIMS provides food producers with the confidence that sample results are within regulated limits and that any failures will be highlighted, triggering follow-up investigation and preventing distribution throughout the supply chain and to the consumer.
For more information about Thermo Scientific informatics solutions, call 215-964-6020, E-mail marketing.informatics@thermofisher.com, or visit www.thermo.com/informatics.
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