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Three Types of Hazards

By | Blog

What are the three types of hazards you need to consider for your Food Safety Plan?


Biological Hazards

Microbiological hazards such as parasites, environmental pathogens, and other pathogens


Chemical Hazards

Radiological hazards, substances such as pesticide and drug residues, natural toxins (such as mycotoxins), decomposition, unapproved food or color additives, and food allergens


Physical Hazards

Stones, glass, and metal fragments


For more information on formulating your food safety plan, read the FDA Regulation for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.

What to Include in Your Food Safety Plan

By | Blog

Key Components of Your Food Safety Plan

According to the FDA’s Small Entity Compliance Guide, a covered facility must have a written food safety plan including the following components:

Hazard analysis

Identify known or reasonably foreseeable hazards. If a facility reveals one or more hazards, then they are required to also have and implement written preventative controls for the identified hazards.

Preventive controls

Preventative controls must significantly minimize or prevent the identified hazards.

Oversight and management of preventive controls

Once a facility has identified a preventive control for a hazard, the facility must make sure that the controls are being met.

Supply chain program

Manufacturers must have and implement a risk-based supply chain program if the hazard analysis identifies a hazard that (1) requires a preventive control and (2) the control will be applied in the facility’s supply chain.

Recall plan

If the hazard analysis identifies a hazard requiring a preventive control, the facility must have a written recall plan that describes the procedures to perform a recall of the product.

For more details, read the FDA’s Small Entity Compliance Guide.

Solus Goes the Extra Mile to Ensure Quality Control

By | Blog

Three Indicators of Quality Control

Quality control is synonymous with making our food supply safer.  The Solus Pathogen Detection System ensures the highest standards of quality for each test. Users of the system can rely on three immediate indicators for confidence in the quality of their results:

Batch-specific ELISA Kits

All components of Solus Salmonella, Solus Listeria, and Solus E. coli O157 kits are quality control tested as a batch combination, labeled with batch numbers and given a certificate of analysis with specific performance results.     

Instrumentation Self-Check

When the DS2 Matrix Software initializes, it performs a self-diagnostic check on the instrument.  The pass/fail function ensures the machine’s components such as the incubator, wash-buffer heads and pipette modules are functioning properly.


Microplate Controls

During each 96-well microplate run, three wells are dedicated to quality control.  Batch-specific positive control containing heat-killed pathogen and a color indicator plus negative control of heat killed none pathogenic organism ensure that every run meets stringent acceptance criteria.


Detect Higher Risk Food Products

By | Blog

Is Your Food Product at High Risk for Listeria Contamination?


The FDA recommends that your environmental monitoring procedures use a risk-based approach in which you establish strategies for environmental monitoring. In general, the greater the risk that an RTE food could become contaminated with L. monocytogenes and support growth of the organism, the greater the frequency of environmental sampling and testing, and the more stringent the corrective actions.

The following questions may be used to determine if a food product is lower or higher risk.

Does the food receive a listericidal treatment to adequately reduce L. monocytogenes?
Yes (Lower Risk) / No (Higher Risk)

Is the food formulated to prevent the growth of L. monocytogenes or be lethal to L. monocytogenes (e.g., through intrinsic characteristics such as pH or water activity)?
Yes (Lower Risk) / No (Higher Risk)

How much handling does the food receive subsequent to a pathogen reduction step and prior to packaging?
Minimal (Lower Risk) / Extensive (Higher Risk)

Does the food receive a listericidal control measure in the package?
Yes (Lower Risk) / No (Higher Risk)

What is the shelf life of the product during refrigerated storage?
Short (Lower Risk) / Long (Higher Risk)

Does the packaged RTE food support the growth of L. monocytogenes under normal storage conditions?
Yes (Lower Risk) / No (Higher Risk)


For more information, read the FDA’s “Control of Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry Draft Guidance

Help Your Team Stop the Spread of Listeria

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Best Practices for Food Safety Personnel

Unknowingly, your team can transfer L. monocytogenes from the processing environment to the food. Following are recommendations from the Food and Drug Administration to help stop this spread.

Everyday Practices

Wash hands thoroughly before entering RTE food processing area.

Use utensils or wear gloves when touching exposed RTE Foods, food-contact surfaces and packaging materials.

Gloves and footwear should be impermeable, in good shape and easily cleanable or disposable.

Keep RTE gloves and footwear contained to RTE areas in your plant.



Establish and implement conditions and practices to prevent employee clothing from contributing to the contamination of food with L. monocytogenes. Depending on the type of operation, such conditions and practices include:

Cover street clothes from the knee and up before entering RTE area.

Smocks and uniforms laundered or disposed of daily.

RTE uniforms distinguished from non-RTE uniforms and worn only in RTE areas.



Here are the FDA’s recommendations for glove usage in your plant.

Wash your hands before putting the gloves on.

Wash and sanitize multi-use gloves before use.

Discard or sanitize gloves after employee touches any non-food contact surface or leaves RTE area.


For more information on FDA recommendations on how to minimize Listeria Monocytogenes in your plant, see the “Control of Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry Draft Guidance Guide.

Clean Your RTE Plant in 7 Steps

By | Blog

The 7 Step Cleaning Process for your RTE plant


In their “Control of Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry Draft Guidance Guide,” the Food and Drug Administration offers their recommended cleaning procedure for ready-to-eat food processing plants including carefully sequenced cleaning actions followed by a sanitizing procedure. The FDA recommends that your written sanitation procedures include the following steps:

  1. Dry Clean – Using appropriate tools (such as brushes, scrapers), remove heavy soils or debris from equipment, then floors;
  2. Pre-Rinse –  Working from the top of the equipment down, rinse and scrub equipment to remove visible soils. Using appropriate tools, remove any additional debris from the floors and drains, and then rinse the floor;
  3. Soap and Scour – Apply foam cleaner to ensure adequate coverage by first foaming walls (if applicable), floors, and then the equipment from the bottom of the equipment to the top. Clean drains using appropriate tools. Scour equipment to remove any residues, and avoid the drying of the foam cleaner;
  4. Post-Rinse –  Remove the foam cleaner by flood rinsing the walls (if applicable), floors and equipment in the same order that the foam cleaner was applied;
  5. Prepare for Inspection – Remove any possible overhead condensation or standing water and prepare the equipment for inspection;
  6. Pre-Op Inspection – Visually inspect the equipment for cleaning effectiveness and correct any deficiencies;
  7. Sanitize and Assemble –  Sanitize the equipment, floors, and (if applicable) walls and prepare the equipment for operation using ATP bioluminescence or other appropriate testing as a sanitation check.

For more information, read the full FDA Guidance.

5 Advantages of the Solus System vs. Market Leaders

By | Blog

CERTUS is proud to bring Solus Pathogen Detection System to the United States and introduce it to the market where it currently offers significant benefits over leading immunoassay systems.

Solus Salmonella and Solus Listeria ELISA kits, proprietary media, and DS2 (2 plate ELISA processing system) streamline your workflow, technician time, and costs to offer you a high-throughput, reliable and robust pathogen detection system.

Here are 5 reasons why Solus Pathogen Detection System outperforms market leaders.

  1. Throughput

It’s simple.  Solus ELISA coupled with a single DS2 unit (instrument and PC), can run 2 plates or 192 samples in a total of 185 minutes.  That is an average of 1.04 minutes per sample.  It is therefore possible on one DS2 unit to run 500 samples per day in one 8 hour shift.

The most popular system on the market in the U.S. can run under 200 samples a day on one machine.  To meet the throughput of the Solus System you would require three of our competitor’s machines with instrumentation.

  1. Time

Time is money and time is limited.  One of the main advantages of Solus Pathogen Detection System over competitors is the efficient workflow, which truly frees up technician time. After the standard enrichment protocol, the hands-on technician time needed to prepare 192 samples for testing on DS2 (including instrument set up) takes well under an hour.  The instrument then runs the 192 samples in 2.5 hours fully automated, meaning the technician is free to perform other lab duties.

  1. Lab Footprint

Many labs struggle with space allocation and cold storage capacity and Solus Pathogen Detection System rightly addresses this issue.

One Solus kit contains enough reagents to process 480 samples whereas current market leader’s kit only contains sufficient materials for 60 samples within a slightly larger box. Additionally, DS2 is only 21 inches in width, freeing up valuable bench space for other instrumentation.

  1. Room for Growth and Scalability

Solus Pathogen Detection System is perfectly poised to scale up with your lab and growth needs.  A trained technician could simultaneously prep and run three DS2’s at once if need be. This would yield nearly 1,675 tests in one 8-hour work day. Additionally, DS2 is a customized open-based ELISA system that could also run allergens, mycotoxins, etc. to truly fit your daily testing needs.

  1. Cost Savings

Cost is the bottom line for most companies. Solus Pathogen Detection System offers not only attractive price-per-test for a complete system, but overall cost savings are also achieved in the bigger financial picture. Smaller box size means less waste and thus less to dispose of and reduced shipping cost. Concentrated formulas and reduced box size mean less cold storage, less overhead cost. Finally, freeing up technician time through the automated system allows technicians to perform other tasks, streamlining labor needs and allowing your workforce to work efficiently and on a variety of projects.

If you are interested in chatting more about the other advantages of Solus Pathogen Detection System or to set up a live demo, please contact me at Shelby.degalan@certusfoodsafety.com or at 872-810-4123.  We are looking forward to demonstrating how Solus Pathogen Detection System can fit your testing needs!

CERTUS™ Announces Exclusive License Agreement for Rapid Pathogen Detection Technology in Food Safety

By | Blog, Food for thought

CERTUS technology is covered by an exclusive license from BD (Becton Dickinson) to commercialize the proprietary technology in the field of food safety. BD acquired the SERS nanoparticle technology due to its value as a platform system that can be applied to many kinds of diagnostic applications. BD further developed and patented the technology to enable detection in a bio-contained tube during enrichment so that the lab or plant where the testing is conducted is not exposed to enriched pathogens.

BD has now out-licensed the technology to CERTUS in an effort to focus on clinical applications of the technology. BD continues to support the CERTUS technology as the supplier of the proprietary SERS nanoparticles.

Risk Management Today

By | Blog, Risk Management

We understand your need to monitor your production environment for pathogenic organisms.

In fact, the FDA is currently proposing to require environmental testing when:

  • A ready-to-eat food product is exposed to the environment before it is packaged; and
  • The packaged food does not receive a treatment that would significantly minimize an environmental pathogen that could contaminate the food.

In all other circumstances, FDA is proposing to require environmental monitoring only “as appropriate to the facility, the food, and the nature of the preventive control.”

Environmental testing typically entails taking microbiological samples of food contact surfaces or nearby areas to test for the presence of a pathogen or indicator organism. For ready to eat foods processed under wet conditions or environments, the organism of concern is generally Listeria monocytogenes.

CERTUS is uniquely positioned as your food safety partner to help educate and work with you to mitigate these risks.

So much so, we developed a proprietary bio-containment system to achieve safe handling and disposition of samples.

Furthermore, we know that food safety is a global issue, and many Food Safety Authorities (Canada, Europe, Australia) are striving for the similar standards, in fact Australia and the US just announced that their systems and regulations are compatible, streamlining the compliance portion of trade agreements.

Visit us at the Annual IAFP Meeting

By | Blog, Upcoming Events

CERTUS™ Debuts at IAFP 2017 Booth #928 with Rapid Pathogen Testing System for Domestic Food Processing Plants

A simultaneous brand launch and upcoming product preview offers IAFP attendees an inside look at the technology and expansive vision of the CERTUS brand. For more information on CERTUS, visit booth #928 at the IAFP Annual Meeting at the Tampa Convention Center in Tampa, Florida July 9-12, 2017.