Chew on This: LIMS Vital in Food Safety

LIMS helps food producers and importers to comply with U.S. legislation regulations and to ensure product quality

Source of Article:  http://www.laboratoryequipment.com/Food-Beverage-Safety-LIMS-0809.aspx?xmlmenuid=28

by Colin Thurston, Director of Product Strategy, Process Industries, Thermo Fisher Scientific

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 (FFDCA) 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. In the effort 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 are designed to manage and control the quality assurance process, organizing and storing analytical data and facilitating the conversion of data to information. This process is fully automated, ensuring that the majority of sample results will be within acceptable limits and filtering and highlighting failures to initiate follow-up investigations. LIMS automatically capture sample data, check for out-of-specification results and assemble data into a variety of report formats for submission to the FDA.

Data management software deployed in the food and beverage industry has evolved from a widespread use of spreadsheets to manage and track laboratory results to the current growing adoption of sophisticated LIMS applications for location management of samples, entering and checking of results, batch tracking and laboratory workload management. The food and beverage market is recognizing that in the current regulatory market, it is not possible to maintain the required level of consumer safety without these modern data management tools.

Data handling

Food analysis techniques produce large quantities of different types of data. LIMS are capable of automatically gathering, storing, managing and reporting 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 websites 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. LIMS helps laboratory analysts avoid any transcription errors associated with conventional manual data management techniques, eliminating data overlaps and lost man hours associated with conventional manual data management methods. The LIMS is also capable of tracking instrument status, identifying any requirements for calibration and/or service and reporting on the specific parts needed replacing.

Maximizing efficiency

The use of LIMS in the food safety workflow ensures that 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 are capable of identifying each sample, uniquely generating labels, barcodes and hazard data and storing metadata and sample lifecycle transactions.

Seamless integration

In large organizations a LIMS plays a key role in the integration of the laboratory environment with enterprise resource planning (ERP) and other critical systems. This allows laboratory test data to be automatically available to plant process and control systems, giving managers immediate accessto results and providing a more automated environment. LIMS offers a flexible technical solution to suit different laboratory and industry requirements and enables both the R&D and manufacturing QA/QC functions to meet the regulatory requirements of the industry with audited data.

Application example

Molkerei Alois Müller (UK) is a market leader in European dairy products. The Müller UK site specializes in yogurt products; from low-fat yogurt offerings to yogurt and cereal combinations. Müller UK sales have been increasing annually since the company entered the UK market due to a focus on quality and innovation. In fact, the state-of-the-art production facility at Market Drayton, that was opened in 1992, has been significantly expanded several times to add more manufacturing, warehouse and distribution capability. Now, Müller produces more than a third of all yogurt eaten in the UK from the Market Drayton factory.

The Müller UK labs are mainly focused on production QC. Milk from farms arrives by tanker and is passed by pumps into silos, 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 two hours. After eight to nine hours of incubation, the pH has dropped and a final pH check is made when the yogurt is cooled. With the checks being performed and recorded manually, there were many places a LIMS could be used to automate and expedite the QC tasks.

The decision to implement a LIMS was driven by the increase in production demand, and justified by the need to increase the lab’s efficiency. Müller UK selected Thermo Scientific Nautilus LIMS to manage QC data for raw materials, in process, and finished dairy desserts. The LIMS had dramatically reduced the amount of error-prone paperwork and expedited testing. The LIMS has also assisted significantly in 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

US regulatory bodies have introduced strict regulations to ensure that all food produced, sold, imported and exported in the US do not pose any health risk to consumers. It is vital for food producers and importers to comply with food safety legislation. In order 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. The ability to trace processes in the food manufacturing and supply chain is a critical function in ensuring product quality and regulatory compliance.

As a result of recurring food safety incidents, consumers are aware and concerned about the safety of the processes involved in growing, manufacturing or delivering their food. It is essential that the health and welfare of consumers be protected by assuring optimum food quality and processes. Achieving complete automation of all laboratory operations, a LIMS provides food producers with the confidence that sample results are within regulated limits, while any failures will be highlighted to trigger follow up investigation and prevented from being distributed throughout the rest of the supply chain and ultimately to the consumer.

 

 

 

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