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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