Traceability: Leveraging Automation to Satisfy FSMA Requirements

By Dr. Christine Paszko
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In America’s food supply chain, food is sourced globally. Since ingredients often come from multiple countries, inspection and quality control is challenging, as regulations, policies and processes differ in each country. Product management begins with the suppliers, from the fields where the foods are grown, to the pesticides and fertilizers used, to harvesting, washing, shipping, storing, and processing (manufacturers), and finally, to packaging and delivery to consumers.

Figure 1. LIMS will facilitate FSMA by providing complete traceability from farm to table, in addition to accelerating collaboration, communication and providing operational insight.
Figure 1. LIMS will facilitate FSMA by providing complete traceability from farm to table, in addition to accelerating collaboration, communication and providing operational insight. (Click to enlarge)

Figure 1 shows each step of the product management process can introduce contamination due to unsafe practices or other risks. As such, test data and traceability must begin in the field and end when the final product is delivered to the consumer. The Laboratory Information Management System (LIMS) captures all information to ensure that quality data is effectively managed, communicated, and easily and quickly accessible in the event of a contamination issue. The LIMS allows producers to provide authorities with the required sampling and testing documentation to prove compliance.

U.S. consumers expect their food products to be affordable, consistent, safe and unadulterated. Consumers have seen numerous food recalls in the news, and it has shaken their confidence. The CDC estimates that about one in six Americans (or 48 million people) get sick, 128,000 are hospitalized, and approximately 3,000 die of foodborne diseases each year. Global food directives for international food initiatives include CODEX, ISO (International Standards Organization), and the Global Food Safety Initiative (GFSI).

The U.S. Government has implemented various food safety programs, from Hazard Analysis & Critical Control Points (HACCP) to FSMA in order to identify and correct potential contamination in the food supply. In fact, one of the primary focuses of FSMA is preventive action based on risk assessment.

The food landscape has changed significantly, especially over the past decade, as consumers demand year-round fresh fruits, vegetables and juices, along with more exotic foods. The fact that U.S. food is globally sourced has resulted in numerous challenges in quality assurance, shipping, traceability, labeling, storage, blending, testing, and reporting.

Use LIMS to track and manage information in a relational SQL Server LIMS database
Use LIMS to track and manage information in a relational SQL Server LIMS database. (Click to enlarge)

For example, upon reading the labeling on an apple juice can, it is not uncommon to learn the juice has been possibly sourced from numerous countries including the United States, China, Brazil, Argentina, Chile and many other countries from the European Union. Oftentimes, labels state that ingredients may come from some of the countries listed, but it does not specify what percentage comes from each country or exactly from which country the product was sourced. Figure 2 shows how LIMS can track and manage this information in a relational SQL Server LIMS database.

A similar scenario is true for tracking hamburger meat: The meat that was used to make burgers can come from multiple ranches and hundreds of cows. Many consumers don’t understand why their food/beverage is blended in large ton batches, and producers want to reach the required final product specifications, while offering a consistent product and experience to the consumer. Blending has become commonplace in the food industry, and it makes traceability much more challenging. The same is true in blending different meats, for example regulators have found pork in products marked 100% beef, this has led to the use of molecular tests to determine if meat has been adulterated.

FSMA and Traceability

FSMA focuses on a preventive approach rather than reaction and response to foodborne outbreaks. A central focus is on traceability, involving a complete understanding of the complex food chain and conducting testing at the key control points that can introduce contamination. It is important to understand the source of all the raw ingredients that make up a final product as well as the details of where they are sourced, the CoA (Certificate of Analysis) report, other test results, and all associated documentation. These elements are especially important, because each region of the world has different approved testing methods and is challenged with different potential contaminants and processes. As a result, food manufacturers must manage a significant amount of information on all raw materials that they receive, along with the associated paperwork, which includes the CoA, confirmatory test data, and all plant, production and final product test data.

Case example. As operations scale, so does the testing. In order to manage all the testing, most laboratories turn to LIMS and laboratory automation to manage high throughput screening. A client that was performing nearly 1,000 Listeria tests per day was using an automated microbiological screening platform to complete this testing. They were struggling to hire more resources to manage and run the instrument, as the time was short and the increased sample volume was imminent. The goal was to automate testing from the nine plants that were submitting samples to the main laboratory, such that the entire process could be automated from the laboratory knowing how many samples were coming from each plant and from deploying pre-configured worklists to upload to the instruments. The instruments would then run the samples and send the result back into the LIMS. This integration alone saved more than six hours per day. In addition, the electronic data transfer was fast and error-free, and since the data was imported into the LIMS, any positives were automatically flagged in real time. This approach allows immediate action.

In addition, all data from shelf life studies and additional testing on the food product (i.e., pesticide testing, environmental testing for Listeria sp., mold, yeast, etc., formulations, and blending) can be managed in the LIMS, one centralized database.

How LIMS Supports FSMA

Over the years some manufacturers have relied on less-robust tools to manage and maintain testing data, from multiple Excel spreadsheets to paper log books. Challenges with using these tools include data corruptions, data loss, typographical errors, and accidental or malicious data changes. These systems are often costly, especially from a resource standpoint (i.e., data errors, hours spent interacting with the data for calculations, tracking samples, and manual report creation alone). In addition, creating reports for regulating authorities can be time-consuming and because there is no control over changes to the Excel sheets or logbooks, there is typically no audit trail, and because the data is not in the database, querying the data can be very difficult.

A quality LIMS will ensure that the organization is bullet-proof when it comes time for regulatory audits. It also provides a complete and secure solution to manage, track and monitor batches of product from farm to table. LIMS not only helps clients manage their regulatory compliance goals, but it also facilitates communication across the organization and provides laboratory intelligence that gives buyers insight into the best suppliers to purchase from, based on final product specification, consistency and pricing. Managers can also better understand when it is time to outsource testing based on workload data, allowing them to maximize their resources and profitably through more efficient operations. The system also accelerates communication: As soon as testing is completed, reports can be automatically emailed and alerts sent to cell phones, if any issues arise.

When dealing with perishable products, time is of the essence, LIMS save time. Table 1 lists just a few of major benefits of the LIMS in FSMA regulatory compliance.

Process/Requirement Advantage
Sample tracking and management Integrated barcode support (both 1D and 2D), manage all batch data, tests, from raw materials, in process testing to final packaged product testing
21 CFR Part 11 Compliance with electronic signature requirements
CoA Easily, automatically generate the CoA report once testing is completed, validated and approved
Specification Management Manage final product, supplier and customer specifications and pricing
Document Management Link all paperwork to Work Order for ready access and retrieval
Full Chain of Custody Automatically generated and linked to the order
Records data and all paperwork associated with product All paperwork that arrived with the raw ingredients, CoA, and shipping documentation or additional test data
Records all test results Automatic data import from instruments as well as hand entered data
Shelf-life Studies Setup, manage and track all aspects of shelf life studies
Formulations and Blending Manage and track as components and specifications for final product blends, and leverage predictive tools for optimal purchase options from suppliers
Audit Trail Track actions in the system and generate a report of all audits made to any result data
CAPAs (Corrective and Preventative Actions) Track and manage open CAPAs in the LIMS, and tie to testing results for easy management to increase customer satisfaction
Traceability back to the source (farm, country) and  forward to the store that it was shipped to, with key data (lot number, ship date, etc.) Users can view all components and associated test results, along with any notes on the final product, back to the supplier and forward to locations that offer the product to the consumer
Employee Training Manage employee training records and view Standard Operating Procedures online to ensure access to work instruction and provide evidence for audits
Instrument Management Manage all quality control data on the instruments used in the testing, as well as documented calibration data, maintenance, any repairs, or any issues. Users can link the PDF manual in the LIMS
Enterprise integration (ERP, SAP, SCADA, MES, SAS JMP) Data sharing allows users with permissions access to data when they need it, so that they can quickly view and monitor information they need to perform their job. Users can also view data with integrated statistical tools to view trends that may not be readily evident
Table I

A LIMS is a critical tool to the success of food companies. It organizes and securely manages all aspects of food testing, facilitates regulatory compliance, enhances communication within the organization, and maximizes productivity. Many food producers are concerned about protecting their brand and providing a high quality, consistent, and safe product to consumers while operating efficiently and at a profit. An LIMS allows them to meet these goals.

Steps to Avoid a Food Crisis

By Maria Fontanazza
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Part two of Food Safety Tech’s interview with Alan Baumfalk, lead auditor and technical manager for Eurofins food safety systems, discusses how companies can reduce their chances of having a food crisis. “Sometimes we forget that part of our crisis management team is part of food defense,” says Baumfalk.

Food Safety Tech: Can you discuss the importance of the food defense plan within crisis management?

Alan Baumfalk: We need to defend the product within our facility, and we need to determine as part of the food defense plan the methods that we’re going to implement to prevent adulteration of product.

We need to step up and watch this: The process literally travels from farm to fork; from the crop through processing through distribution and to the final consumer. As part of our food defense plan we need to protect sensitive processing points from intentional adulteration, and we must watch for potential accidental adulteration.

It is important to carefully control the activities in the plant. Part of that involves limiting employee, subcontractor and visitor access to production equipment, manufacturing, and storage areas by designating access points.

These steps can help to eliminate issues involved in causing a crisis:

  • Secure the storage of raw materials, packaging equipment and hazardous chemicals
  •  Control all chemicals within the facility, because they can be used to deliberately or accidentally contaminate food.
  •  Hold finished products in secure storage.
  •  Control transportation. Apply seals to the full truckload.
  •  Monitor all points of distribution.
Steve Goldner

Federal Marijuana Policy: A Q&A with Stephen Goldner

By Aaron G. Biros
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Steve Goldner

Ahead of the launch of our newest publication, CannabisIndustryJournal.com, I interviewed Stephen Goldner, President of Regulatory Affairs Associates, regarding the possibility of federal oversight in the cannabis industry, namely direct FDA involvement via regulations.

With experience as a forensic toxicologist and attorney, Stephen Goldner has worked over 35 years as a regulatory professional in the healthcare space. He has contributed to the approval of 230 drugs and medical devices serving as an FDA advisor. Steve is credited with the development of the liquid dose form of methadone and various screening tests for drug abuse.

We discussed the current regulatory frameworks in place for legal marijuana in the United States and found that there are some gaps in understanding when it comes to regulating the plant. Here is a snapshot of our conversation discussing federal involvement in the cannabis industry:

 

Food Safety Tech: Are state governments and marijuana businesses working jointly to handle the regulatory framework succeeding? Can you see, in the handful of states that have already legalized marijuana, a need for FDA regulatory guidance?

Steve: To many people’s surprise, the states that have legalized marijuana are doing very well setting up a regulatory framework. Plus, the legitimate operations really want to succeed in business and provide safe and effective recreational and drug products. I’m surprised to hear myself say it, but FDA might be best served if it stayed out of this issue for a while.

FST: What are some reasons why the FDA might want to get involved in the cannabis industry?

Steve: Certainly if there were reports of injuries, but so far the marijuana products seem to be much less hazardous than other common recreational substances like beer and wine. But FDA also gets involved when there are outrageous claims that products cure diseases like cancer. I expect FDA will act against cannabis distributors who make those claims, even if they only distribute their marijuana within one state.

FST: What are some reasons why the FDA might want to let this social experiment run a little longer?

Steve: Thousands of people have gone to jail or otherwise had their life ruined because of small amounts of this product being used or being sold. If it turns out, as the data appears to show, that marijuana is not a ‘gateway drug’ to other drugs, and it’s use is fairly harmless, then FDA stepping in will probably just send most of the users and growers into the black market and then nothing will have been gained.

FST: What actions might you suggest the FDA take in the near future as more states continue to legalize marijuana?

Steve: Great question! FDA is excellent at monitoring data, along with the CDC. If FDA sees a real health hazard problem, it can convene a panel of experts to offer solutions. And then monitor the situation to see if growers and producers of marijuana edibles can adopt those solutions into their business practices.

 

Ahead of a number of state reforms and initiatives to legalize the recreational use and sale of the plant in 2016, The New York Times published an op-ed by The Editorial Board in favor of removing marijuana from the Controlled Substances Act. While Goldner, along with many others, believe that states are making great strides with regulatory measures, The New York Times believes “State legalization efforts are not uniformly well thought out, which is another reason for Congress and the president to act.”

With the 2016 elections fast approaching, we hope to see major changes coming soon in the federal government’s position on marijuana.

We want to hear your thoughts! Do you think the federal government should step up their involvement? What actions or inactions would you like to see the federal government take? Do you think the FDA should chime in? Post your questions or thoughts in the comments section below.

Complacency Kills. What To Do Before a Recall

By Maria Fontanazza
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A control point breakdown can lead to a food safety recall. Here’s what to expect, what to do, and how to move forward. But most importantly, this discussion with Alan Baumfalk, lead auditor and technical manager for Eurofins food safety systems, will focus on prevention and re-evaluating whether your company’s current plans will be effective in the wake of a recall.

Food Safety Tech: What is the role of the crisis management plan as it relates to a company’s food safety program?

Alan Baumfalk: The crisis management plan is an interwoven topic. Some people use crisis management or business continuity interchangeably, but they tend to have a bit of a different focus.

First of all, a crisis management plan usually goes together with a food safety plan, and in some cases, it is part of a food safety plan. We are all familiar with the food safety plan, which includes a HACCP plan (Hazard Analysis and Critical Control Points). HACCP consists of seven principles. We’re all involved in HACCP everyday; it’s related to everything we do. We identify the hazards that might be involved in the food we’re producing; we identify the hazards that might be involved in our daily lives (for example, we choose no to drive in rush hour traffic because of the potential hazards that might be involved).

This all fits into our food safety program where we try to eliminate risk through risk assessment. We establish critical limits of what we will and will not accept, and then we monitor and verify them. We take corrective actions when something we monitor is not within that critical limit. Verification involves verifying that what we’re monitoring is indeed being monitored, and finally, there is record keeping.

The crisis management team wants to prevent a recall, which is a crisis to the business, to the brand, and to the health and welfare to the public. No one wants to have a recall. When putting together this plan, you need to make sure you have a multidisciplinary team. It cannot consist of all sales people, nor can it be solely quality control people. You have to bring in people with certain expertise: Include people that are from legal, media/communications, and the business group.

FST: In preparing for a crisis, where does business continuity planning fit into the picture?

Baumfalk: Crisis management has two additional components—the business continuity plan and the food defense plan. They are not exactly the same, and they are not necessarily interchangeable. The business continuity plan is related to how you are going to continue your business if you have a situation that occurs. It can be a crisis that involves a buyer, an environmental hazard, or a physical hazard, for example.

Sometimes people will consider what is happening in the media right now. What happens if there’s an incidence at the local school and your employees have children there. What are you going to do and how will you respond? How will you continue to do business in a safe way?

When putting together a business continuity plan, you need to ask yourself, how are you going to cope with the business crisis and continue doing business.

  • Designate a senior manager who is in control of handling the organization and making the necessary decisions.
  • Identify a multidisciplinary crisis management team. Each person should have a specific responsibility (i.e., medical, regulatory services, contacting customers, suppliers and internal/external communications). Each team member should be prepared to respond to food safety issues.
  • Develop a contact list that includes legal and various experts in the industry.
  • Train employees.
  • Devise a worst-case scenario and practice, practice, practice. The plan should be tested rigorously and on an annual basis.

When we talk about a mock recall, one of the biggest deficiencies is that people don’t rigorously test it. The number one priority should be to have the plans in place and test them, and identify the weaknesses that you can correct. One of the biggest problems that may eventually cause a recall is complacency. The employees think they got it all covered. It’s important to note that an ounce of prevention is worth a pound of cure.

In Part II of this series, Baumfalk will make the connection between crisis management planning and food defense.

hemp-infused tea

Hemp-Infused Beverages: FDA Compliance and the Cannabis Industry

By Aaron G. Biros
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hemp-infused tea

With cannabis-infused edibles gaining a bigger market share in 2014 (See the marijuana edibles regulatory update here), it comes as no surprise that cannabis-infused beverages are growing in popularity. Some of these beverage manufacturers operate in a very interesting legal environment because of the differentiation between compounds found in hemp and marijuana, two different varieties of cannabis.

“Under federal legislation, there is an exemption for hemp and as long as we process our CBD (Cannabidiol) molecules from the hemp plant, we are allowed to sell our products federally,” says Chris Bunka, CEO of Lexaria, a company that makes a hemp-infused tea.

hemp-infused tea
Lexaria’s ViPova black tea infused with CBD oil made from industrial hemp

A number of scientific research studies have suggested that the compound CBD has medical properties that can help mitigate symptoms like inflammation, anxiety, chronic pain, and much more.

Because of the federal exemption for hemp, Lexaria can enjoy interstate commerce and other freedoms that manufacturers using marijuana flowers do not, such as access to banking services. Dried marijuana flowers contain the psychoactive compound, Tetrahydrocannabinol (THC). This compound is responsible for the regulatory and legal schism between the states that have legalized marijuana and the federal government, which still considers it to be a Schedule I narcotic.

Much unlike a number of marijuana edibles manufacturers operating in states where marijuana is currently legal, hemp-infused beverage manufacturers operate in full FDA compliance.

Michael Christopher, founder of Loft Tea, is working with a laboratory and bottler that are both 100% FDA compliant. “We definitely operate up to and abide by all FDA best practices with our laboratory and as far as producing and handling material we use best manufacturing practices and processes,” says Christopher.

“We have to partner with a bottler and laboratory who have the reputation to build trust with our brand as an industry leader in safety and quality,” says Christopher. “Until the FDA gives us complete guidelines on cannabis-infused products, we will continue to operate above and beyond best manufacturing practices with our infusions.”

Because these manufacturers view their hemp tea as a health and wellness product, it is only a matter of time before we see these types of products lining the shelves of health-food stores nationally. However, before this happens, an FDA regulatory framework specific to hemp-infused products is needed to address this growing industry.

“The hemp infusion industry has a lot of opportunity when presented in the right framework,” Christopher says. “There is still education needed in the marketplace to get it to the point where it will be on the shelves in stores like Whole Foods.”

Until that time comes, expect to see a steady growth of interest and inquiry from consumers, manufacturers, and regulators alike in the cannabis industry, whether federally legal or not.

RFID tags on drying marijuana flowers

Marijuana Edibles: Update on a Rapidly Developing Market

By Aaron G. Biros
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RFID tags on drying marijuana flowers

A lot has changed since last year’s article, “Marijuana Edibles: A Regulatory Nightmare.” Marijuana has since catapulted into mainstream thinking via activism, state decriminalization, and medical reforms while investors and banks are beginning to trust the market more, further legitimizing the nascent industry. According to an article from the Washington Post, Colorado’s legal marijuana industry reached $700 million in 2014 and is expected to grow to $1 billion by 2016.

Innovators are beginning to analyze trends on a national level, looking toward federal rescheduling of the drug as a catalyst for more state reforms and wider legalization measures. Federal legalization is in the back of many minds, as the introduction of pivotal state and federal legislative reforms promises more access to banking services, medical research, and more state independence.

While a black market mentality remains prevalent, widespread state reforms, increased venture capital investment, and further legitimization of an industry with less barriers of entry have fostered a perceived reduction in risk. States like Oregon, Washington, and Colorado that have already legalized marijuana for recreational and medical sales are beginning to implement strict packaging rules, requirements for traceability, QA programs, testing and laboratory monitoring requirements, and other regulations that would suggest FDA oversight down the road.

marijuana buds drying in racks biotrackthc
Dried marijuana buds curing with RFID tags as part of the traceability system of BiotrackTHC

State regulatory bodies such as the Colorado Marijuana Enforcement Division (MED) have matured and expanded their oversight to include certifications and requirements for lab testing and analysis. Marijuana testing facilities can now be certified by the MED to test for residual solvents, poisons or toxins, harmful chemicals, dangerous molds, mildew or filth, harmful microbials such as E. coli or Salmonella, pesticides, and THC levels and Cannabinoid potency.

According to an article from theCannabist.com, edible marijuana took 45% of the market share in 2014 and continues to grow, proving that food manufacturers and processors will gain a bigger share of the market.

BioTrackTHC develops a seed-to-sale traceability system that is the state-mandated reporting system used by any business that touches the plant in compliance with Washington’s i502 regulations (The company also won the contract bid for New Mexico’s and New York’s state-run traceability systems). “From day one, all retail products under i502, including infused edibles, must have laboratory-submitted passing test results and data in the traceability system before it can be unlocked for shipment to retailers,” says Patrick Vo, CEO of BioTrackTHC.

RFID tags on drying marijuana flowers
RFID tags on drying marijuana flowers, from BioTrackTHC

Regulations, especially those addressing traceability, are crucial for advancing the industry and fighting the black market, performing recalls, and improving product quality and safety. Vo adds, “As more states adopt a centralized traceability system, food safety will improve as we see the industry grow.”

“Most of the marijuana edibles producers we advise are working comfortably within their state health department regulations versus a year ago when they were struggling to implement routine compliance,” says Stephen Goldner, CEO of Regulatory Affairs Associates.  “But there is a long way to go to make this new marketplace meet the standards routinely met by US food producers in other markets such as nutritional supplements and medical foods.”

Many edible producers are sadly mistaken to ignore FDA labeling and production regulations just because the producer only ships within their own state, according to Goldner. “Whenever FDA has found label or food safety violations of products, whether they are food, drugs or any other product, it has always acted quickly to seize the product, inspect the producer and insist that violative labeling or production practices be remedied,” he says, adding that it won’t be surprising to see FDA start to “seize marijuana-infused food products that make drug claims, especially from the leading current producers” as a way for the agency to insert itself into the inspection and compliance process. “These companies need to have FDA food GMP’s solidly in place and properly documented,” says Goldner.

“Those who have experienced the most consistent and long term success in this industry are those who play above board, those who take the extra effort and make the investment in effort, time, and money to treat their business as if it was already federally legal and had to adhere to standards that other industries must follow,” says Vo. He agrees with the view held by many that long term planning is vital in this industry. “Those who have implemented best practices, QA programs, and traceability software will succeed in the long run, and the bad actors will eventually, by their own poor practices, be filtered out by regulatory and market forces.”

In the near future, the industry will look to other states in regulatory experiments on opposite sides of the spectrum. “New York, which legalized medical marijuana in 2014, is handing out 5 licenses to operate 4 dispensaries each, and allowing licensees to have a grow facility to supply their respective dispensaries. The Commissioner of the New York State Department of Health will have authority on licensing, testing, and medical requirements for patients seeking treatment with medical marijuana,” says R. David Marquez, who operates a Long Island law firm focusing on the cannabis industry.

New York is implementing very strict rules regarding cultivating and processing the plant. California, on the other side of the spectrum, already operates a somewhat loosely regulated medical marijuana market and has been doing so since 1996. The bill to legalize marijuana recreationally in the state is widely expected to pass vote and be implemented in 2016. This would open up an enormous market potential and contribute to the growth of the industry on a national level.

Because marijuana edibles are theoretically both a food and a drug, it is only appropriate that the FDA should look to regulate the industry in the future. In the meantime “Those who have invested the time and money in staying compliant now will be far ahead of the game tomorrow,” says Patrick Vo, who is looking toward federal legalization.

It seems that manufacturers and processors at the forefront of quality and safety testing will succeed in the long run.

Footnote: This is a regulatory update on the cannabis industry with an emphasis on edible marijuana. CannabisIndustryJournal.com, the newest publication, will be launched in September of this year. CannabisIndustryJournal.com will educate the marketplace covering news, technology, business trends, safety, quality, and the regulatory environment, aiding in the advancement of an informed and safe market for the global cannabis industry. Stay tuned for more!

Why Should Food Manufacturers Consider Lab Automation?

By Dr. Christine Paszko
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Food manufacturers that think strategically understand that labor efficiency is a measure of how effectively a workforce completes a task in comparison to industry. Companies frequently access efficiency and other metrics to identify weak points in their operations, with the end goal of enhancing data quality and streamlining costs. This approach has led many food and beverage manufacturers to embrace lean manufacturing and six sigma programs in their organizations. These leaders have a clear understanding that labor is money (or money is stored labor), and money equals margins. Food and beverage manufacturers often acquire several raw materials and convert them into finished products for consumers to purchase. These manufacturers have found that robotics and automation have greatly increased productivity and enhanced product quality while maximizing resources and profitability.

LIMS offer a variety of benefits. Image courtesy of ATL
LIMS offer a variety of benefits. Image courtesy of ATL

Ease Operations with Automation

Analytical testing laboratories within food manufacturing firms leverage LIMS to realize automation savings. LIMS is an acronym for Laboratory Information Management System, which can also be a manual paper/Excel based solution, however, this article will focus on completely automated, computerized, enterprise, software solutions. Manual systems are cumbersome, costly, and lack efficiency.

Just as automation and robotics have transformed the food manufacturing process, intelligent laboratory operations leverage LIMS, because it enables increased quality and faster turnaround, while providing significant cost savings. LIMS are computerized systems that organize, manage and communicate all of the laboratory test data and related information such as Standard Operating Procedures (SOPs) and Certificates of Analysis (COAs), final analysis reports, invoices, nutritional labels, formulations and information to support an organization’s operations and meet regulatory compliance goals.

Traditional LIMS facilitate overall laboratory organization, from sample management to test data to final reporting and disposal. LIMS begin with sample management and typically the generation of barcoded labels (of a unique identification number), testing is automatically assigned based on project or sample type (Note: Additional tests can be added or deleted, and ad hoc samples can also be logged). Some laboratories test all raw materials that arrive to confirm acceptance criteria against the COA, in addition to in-process, final product testing and environmental testing. Once samples are logged into the system, worklists are created in the LIMS of the samples to be run and the information is scanned via barcode and sent to the instrument controller. Tests that include associated quality control data are run by loading instruments. Results are electronically imported back into the LIMS from instrumentation (this is the most common and most efficient method). For manual, subjective tests that require interpretation, results must be entered into the LIMS by hand. Managers can also manage and track samples that have been subcontracted to other laboratories (i.e., for testing capabilities that do not exist internally). Once the subcontracted data is submitted back to the laboratory in an electronic format, it can be directly imported into the LIMS, and all data related to the sample is stored in a single, secure database.

Automation significantly reduces cost, enhances quality and provides a means to rapidly scale production. This image shows a cheese processing plant. Image courtesy of ATL
Automation significantly reduces cost, enhances quality and provides a means to rapidly scale production. This image shows a cheese processing plant. Image courtesy of ATL

This approach offers a major advantage, especially to global operations, due to the ability to deliver real-time data across an enterprise. End-users can leverage the technology to make intelligent buying decisions based on product specifications of incoming raw materials, customer demand, specification criteria and blending simulations.

Managers can view a variety of metrics, including the number of samples that have been run for a particular product, statistical process control charts, instruments in service for workload management, and supplier performance in any given period. Complete product traceability is possible.

LIMS has evolved to manage many additional functions, such as communications with ERP/SAP systems, shelf life studies, performing skip lot testing, formulations, and field and plant data collection by integration with tablets and smartphones for real-time updates, managing competitive analysis data as well as special projects. A few of the major areas in which LIMS are leveraged include:

  1. Sample management of all testing initiated
  2. Quality assurance (including in process quality checks)
  3. Workflow management (optimization of processes)
  4. Regulatory compliance (FSMA, GFSI, HACCP, FDA)
  5. Specification management, formulations and blending
  6. Dashboards for real-time updates (in a single site or across operations)
  7. Customer relationship management (organizing and responding to customer inquiries)
  8. Reporting (COA, final analysis and invoice reports)
  9. Inventory management and product release

Enabling Standardization

A LIMS not only enhances communication across a laboratory, but also across a global organization with multiple sites, ensuring effective cooperation and relationships between suppliers, production and customers. A LIMS promotes standardization in global firms and gives management teams real-time data access from site to site, so that data is readily available for better management and resource allocation decisions. Standardization makes business and financial sense, as organizations can realize cost savings in buying testing equipment and supplies in larger quantities, exchanging staff to different sites (potentially reducing training costs), and managing a user-friendly, single secure database that supports localization (each site can implement LIMS in its native language). Standardization does not mean that systems must be ridged; each facility can leverage its own unique workflows and terminology while saving data to a standard database format.

A LIMS can manage an entire organization’s laboratory SOPs or work instructions, and documents associated with the following:
  • Laboratory testing
  • Assets
  • Inventory
  • Laboratory chemicals
  • Supplies
  • Formulations
  • Blending
  • Automated calculations
  • Customer interactions
  • Employee training records
  • Laboratory instrumentation
  • Purchase orders
  • Sample storage
  • Reporting
  • Invoicing
  • Facilitating governmental laboratory compliance requirements

Today, LIMS’ have expanded to manage all aspects of laboratory operations and have significant overlap with ERP, SAP systems and other enterprise solutions. The goal is to move away from multiple separate databases and distinct islands to one centralized data management solution. Amazingly, some laboratories do not make the investment in new LIMS technology and continue use in-house created database systems, manual paper systems and Excel spreadsheets (or a combination of these systems) to manage portions of the critical product testing data. These systems are often costly, labor intensive, subject to data loss, and difficult to manage and maintain.

A LIMS ensures that analytical resources have been best utilized to maximize productivity and efficiency to generate high-quality data to support operations, while facilitating regulatory compliance goals. Organizations that embrace quality often leverage technology such as LIMS, and typically hold ISO 17025 certification and embrace six sigma, lean manufacturing and other best practices.

Robotics has transformed food manufacturing to allow greater volumes of final product to be produced, with an emphasis on speed, standardization, consistent product quality and volume, with increased efficiency and cost savings. LIMS’ have transformed the manufacturing process and the laboratory analysis process from raw material testing to in-process /environmental testing and finished product testing. For example, on-line monitors can feed data into an LIMS (i.e. flow, temperature from freezers or incubators), and if there are any alarming data points, instant notification is provided to the team via email or a phone call. This rapid response saves time for a corrective action to be put into place. Within the laboratory, if a shelf life study is underway and the incubator fails, an alert can be sent after one out-of-range temperature measurement, allowing the problem to be corrected and the study saved, versus having to start over.

The analytical testing group in any food and beverage testing facility generates hundreds, thousands, even millions of data points a year. They gather data on raw materials (based on COAs), in-process manufacturing (quality checks, statistical process control and specification confirmation), environmental monitoring, and finished product testing as well as performing competitive analysis. These are some of the main areas that are impacted by sample collection and testing. LIMS and laboratory automation have transformed the way that data is collected, monitored and analyzed. Today’s LIMS’ are based on modern technology, providing a valuable tool to ensure that product is within specification, and collected and disseminated in real-time to improve efficiency, reduce costs, increase profitability.

Rapid and Robust Technologies Improve Sample Preparation for Analyzing Mycotoxins

By Olga I. Shimelis
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Mycotoxins are produced as secondary metabolites by various mold species during the growth and harvest of grains, fruits, nuts and condiments. Their production is directly related to the dry/wet weather conditions during the growing season. Mycotoxins are very stable compounds and are not easily removed during storage, processing and preparation of raw agricultural commodities.

Mycotoxins & Grains
Mycotoxins can be found in a variety of grains.

Different classes of mycotoxins are distinguished on the basis of the structural similarity and originating mold species. For example, more than a dozen different aflatoxin compounds exist but only five of them are routinely tested (aflatoxins B1, B2, G1, G2, and M1). Aflatoxin B1 is of particular interest because it is listed as a Group 1 Carcinogen by the International Agency for Research on Cancer (IARC). Aflatoxin M1 is a metabolic product that can be present in milk upon ingestion of aflatoxin B1 by an animal. Aflatoxins are ubiquitous in important agricultural commodities including maize and peanuts, and are among the most studied mycotoxins.

Deoxynivalenol (DON) is produced by a different fungi species. It is prevalent in cereal crops grown under wet conditions and temperatures above 15o C (60o F). Chronic exposure of livestock to DON may result in slowed growth, impaired immune function and reduced rates of reproduction, particularly in non-ruminants.

Mycotoxins were discovered as the cause of poisoning outbreaks in both humans and farm animals in the mid-20th century. Since then, multiple government regulations were established to control the presence of these toxic compounds in food and feeds. For example, harvested grains are checked for mycotoxin contamination using rapid field screening methods prior to grain deposition into silos. If contamination is found, the crops are sent to an analytical laboratory to perform the confirmation analysis. Liquid chromatographic methods were often used for such analysis with both fluorescence and UV detection. In recent years, mass spectrometry has been employed as a detection method.

Sample Preparation for Laboratory Mycotoxin Analysis

When performing analysis, it is important to choose the right sample preparation method to ensure accuracy, sensitivity of detection, repeatability and robustness, as well as fast sample preparation for high throughput. During laboratory analysis of mycotoxins, the sample preparation procedure typically includes extraction, purification and concentration steps.

Extraction of mycotoxins from samples is conducted by mixing the ground sample with the mixture of organic solvent and water, such as acetonitrile:water (80:20). Using methanol is not recommended, because it does not provide complete extraction. Prior to cleanup, the sample is filtered. Historically, mycotoxin analysis required extensive extract cleanup to minimize interference by matrix components. This holds true as new regulations continue to require lower detection limits.

Cleanup methodologies often include the use of phase extraction (SPE). Of the different types of SPE, one of the most common is the use of immunoaffinity sorbents that result in the selective retention and cleanup of mycotoxins. The drawback to using the immunoaffinity sorbents in the lab is that they are not compatible with the mycotoxin extraction solvent. In order to load the extract into the immunoaffinity SPE tube, the extract must be diluted with water, sometimes 20-fold, to prevent precipitation or folding of the protein-based antibodies by exposure to organic solvent. This presents an additional sample preparation challenge, as the grain extracts tend to form precipitates upon the addition of water and can clog the SPE columns. Thus, apart from the high cost of immunoaffinity SPE columns, the methods tend to be labor and timeintensive.

Super Tox SPE cartridges
Super Tox is a line of SPE cartridges for mycotoxin families that eliminates extra sample prep steps.

It would be beneficial to a laboratory to eliminate these extra sample preparation steps required by immunoaffinity SPE. Such cleanup SPE procedures are available and can be applied directly to the mycotoxin extracts without the need for further dilution, filtration and evaporation. A line of SPE cartridges for different mycotoxin families was recently introduced to the market. These SPE cartridges are compatible with the extracts generated during mycotoxin extractions and can be stored at room temperature. The tubes can also be used for cleanup of multiple classes of mycotoxins.

Analysis of Aflatoxins and Zearalenone

SPE cartridges are available for aflatoxins and zearalenone.
SPE cartridges are available for aflatoxins and zearalenone.

The following results employed SPE cartridges for mycotoxins that can be used for two aflatoxin classes, aflatoxins and zearalenone, and were applied to the cleanup of grain and peanut extracts. Results were compared to cleanup using immunoaffinity columns.

AflaZea SPE cartridges are based on the “interference removal” strategy that requires fewer processing steps compared to the “bind-and-elute” strategy of the other SPE. Peanut extracts contain not only co-extracted protein and complex carbohydrates but also fat. This extract was successfully cleaned using AflaZea SPE. When the SPE tube and a leading IAC column were applied to the peanut extract, both methods demonstrated good recoveries for spiked aflatoxins B1, B2, G1, G2 with AflaZea recovery values of 101–108% and immunoaffinity recovery values of 79–100%. However, the AflaZea provided better reproducibility for detection with a relative standard deviation (RSD) of 2–4% RSD versus 10–25% RSD with immunoaffinity SPE. This is likely because sample preparation using AflaZea is less tedious and takes one tenth of the time compared to immunoaffinity SPE.

Analysis of Deoxynivalenol

Wheat samples can be analyzed for deoxynivalenol using a new SPE cartridge.
Wheat samples can be analyzed for deoxynivalenol using a new SPE cartridge.

The following compares a new SPE cartridge for the analysis of DON, one of the Fusarium mycotoxins, with immunoaffinity SPE. Analysis of DON often is conducted using liquid chromatography (LC) with UV detection, so sample cleanliness is important to permit the separation of the DON peak from background interferences. The new SPE DON cartridge was compared to the immunoaffinity SPE for the cleanup and analysis of wheat samples. Clean chromatography and good recovery of spiked DON was obtained by both methods (86–97% RSD). However, clogging of the filters by the immunoaffinity SPE sample was observed during cleanup and complicated the sample preparation procedure. The SPE DON cartridge provided faster sample preparation.

Analysis of Patulin

Patulin is a mycotoxin commonly found in rotting apples.
Patulin is a mycotoxin commonly found in rotting apples.

Another SPE technology for mycotoxin analysis is based on molecularly imprinted polymers (MIPs), which are sometimes called “chemical antibodies” and mimic the performance of immunoaffinity sorbents. MIPs have binding sites that conform to the shape and functionality of specific compounds or compound classes. Strong binding of the analyte to the MIP makes it possible to perform intensive SPE washes that lead to very clean samples. Unlike immunoaffinity sorbents, MIPs are compatible with organic solvents and strong acids and bases.

Foods containing apples and similar fruits are required to be tested for patulin toxin, as they are the most common source for patulin exposure in humans. The MIP SPE procedure for patulin is faster than other SPE or liquid-liquid extraction methods and provides selective retention and superior cleanup. It is a robust method for analyzing apple juice and apple puree with HPLC-UV detection. After cleanup, patulin is quantified in apple puree at 10 ppb levels, which meet most regulatory requirements. The MIP SPE cleanup method eliminated 5-(hydroxymethyl)furfural (HMF) from the matrix, which sometimes appears as an interfering chromatographic peak when other sample prep methods are used. An SPE wash using sodium bicarbonate removed the interfering organic acids, while patulin was stabilized during elution at the end of the SPE procedure by using acidified solvent. Thus, most problems encountered during patulin analysis were resolved during this single SPE procedure.

Conclusion

As government regulations and consumer demand warrant cleaner, non-contaminated products, mycotoxin analysis will continue to be performed around the world. Careful selection of sample preparation methods is required for such analysis to achieve accurate testing results, best method performance and high laboratory throughput. Although many sample preparation methods exist, laboratories should choose the methods that not only provide adequately prepared samples, but also result in time and cost savings. The SPE technologies discussed in this article are sample preparation techniques that provide the required analytical sensitivity without capital expenditure into higher-end LC-MS equipment; the LC-UV and LC-FL methods can still be used. In addition, these SPE methods are simple, more robust, and less-time consuming compared to other SPE methods or liquid-liquid extraction.

All images courtesy of Sigma Aldrich

Participating in VQIP a Gold Star in FDA’s Eyes

By Maria Fontanazza
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Acceptance into the Voluntary Qualified Importer Program serves as proof that your company has a best-in-class food safety program.

As is evident in the name, the Voluntary Qualified Importer Program (VQIP), is just that—voluntary. However, participants in the program are showing that they are going above and beyond the requirements (i.e., FSMA’s Foreign Supplier Verification Program), which in the long run, is good for business and their marketing.

“VQIP is meant to be a step up—it’s almost a push for regulators to offer incentive programs for those suppliers and a way to reward good behavior,” said Melanie Neumann, executive vice president and chief financial officer of The Acheson Group. “VQIP is looking for a best-in-class supplier control program, and it’s meant to incentivize those companies who have it and can prove it.” During a recent FSMA Fridays session organized by SafetyChain, Neumann and David Acheson, MD, CEO and president of The Acheson Group, discussed the basics of VQIP and the benefits of participating in the program.

Under FSMA, FDA is required to develop a voluntary and fee-based program that enables expedited review of foods from importers that have achieved specific criteria related to supply chain safety and security.  The agency released the draft guidance in June. The annual fee to participate in the program is estimated to cost $16,400, and FDA has also requested comment as to whether this fee will pose a burden on smaller businesses. Applications are filed online.

To qualify for participation in the program, companies must meet several requirements. Businesses must:

  • Have a record of importing foods into the United States for at least three years
  • Have a Data Universal Numbering System (DUNS) number
  • Use a paperless filer/broker that has received a pass rating from its FDA filer evaluation
  • Have a quality assurance program and submit documentation of assurance program
  • Be compliant with FSVP

Businesses must not:

  • Have any imported food that is subject to either an import alert or Class I recall
  • Have any ongoing FDA administrative or judicial history of significant noncompliance
  • Be subject to any safety or security customs and border protection penalties and sanctions

One of the most important elements of the eligibility requirements is proof of a quality assurance program, according to Acheson. He highlighted several components that companies must have as part of their quality assurance program, including:

  • Corporate policy quality statements, relating to food safety and security explaining how a company is controlling risk in its supply chain
  • An organization chart (or a written explanation of management structure)
  • Policies and procedures that will be implemented to ensure a company’s system is producing safe food
  • Written description of the food defense system
  • Documentation of a company’s experience in employee training for those responsible for implementing the quality assurance program
  • Procedures for assuring the program is current and appropriately implemented
  • Written procedures for maintaining records relating to structures and process and procedures of the program
  • References to sources used to develop the quality assurance program

“The message here is that FDA is saying we really want to make sure you have a robust system,” said Acheson. He added that although businesses must apply each year, once the initial heavily lifting is done the first year (and assuming the company has maintained the required standards), reapplication should not be as onerous.

Once a company has been accepted into the program, it can expect expedited entry of imported foods into the United States and limited examination or sampling of VQUO foods (unless there is a “for cause” situation).
 
“If you have qualified for this program, you’ve really got the FDA gold star,” said Acheson. “That’s a marketable item. If you can say your product is VQIP approved, it’s a leverageable opportunity for the importer for their customers.”

Food Defense Culture is Coming

By Maria Fontanazza
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FSMA’s proposed rule on intentional adulteration isn’t the only reason companies should be paying attention to food defense.

Establishing metrics in food defense, similar to the growing awareness around the importance of measuring behaviors in a food safety culture, was a topic recently brought up at FDA’s FSMA public meeting in the spring. The agency acknowledged that it will need to both clearly define what exactly is intentional adulteration and how it can be measured.

While food safety involves assessing and mitigating hazards, food defense is all about the threat and protection against intentional contamination. “The threat of fraud is a growing problem as supply chains get more complex, resources grow scarcer and the cost of food increases. All this provides more opportunity and potential reward for food adulterers,” stated a recent PwC report on food trust.

The FSMA final rule Focused Mitigation Strategies to Protect Food Against Intentional Adulteration is scheduled to be published in spring 2016, and companies need to be revisiting and revamping their food defense plans to prepare.

Prevention is the key word and on the most fundamental level of a food defense plan, businesses need to have management commitment before building, or even revisiting, a food defense plan—do they understand the resources, time and cost involved?

Conducting a vulnerability assessment is the first step in finding the gaps and examining whether a facility is secure. Beyond the standard questions that companies may ask when embarking on this assessment, businesses should identify potential attackers, asking how an attacker could have access to a product or process and what would be the outcome of an attack. Then look at the protective measures that are already in place—would these act as a deterrent? And if deterred, would the attacker proceed to the next target or would he or she stop? What measures are in place to find the attacker before there is an effect on the product?

When developing a food defense plan, there are several areas of potential vulnerability:

  • Shipping and receiving and packaging
  • Laboratories and testing sites
  • Recall and traceability programs and processes
  • Water used in processing/manufacturing—what is its origin?
  • Employees—what are the health risks? Is there a process for employee health reporting? Is there a process for reporting disgruntled employees?
  • Security personnel

With food fraud on the rise, it’s important for companies to continue to revisit and update their food defense plans, considering changes to facility designs or strategies, packaging changes, security improvements, etc. Companies should also be proactive in monitoring their employees both from a satisfaction (reducing the incidence of a disgruntled employee) and awareness perspective. FDA has initiatives to help companies build a food defense culture and employee awareness, including the ALERT training course for owners and operators of food facilities and Employees FIRST, and the National Center for Food Protection and Defense has programs aimed at workforce training as well as undergraduate and graduate curriculum on food defense.