The Busy FSQA Manager's Guide to 
Proactive Plant Sanitation


The role of food safety quality assurance (FSQA) professionals is an important one. You must understand the regulatory requirements around food safety, know how to handle common bacterial problems, and be prepared to quickly react to outbreaks. Of course, when it comes to food safety and the related financial consequences, preventing an outbreak is always better than reacting to one.

One of the best ways FSQA managers can be proactive about food safety is to destroy existing biofilms and prevent new ones from forming. This can be challenging with limited manpower and aggressive manufacturing schedules, especially if the solution requires mechanical action. It’s no secret that FSQA managers and their teams are busy, but that doesn’t mean outbreak prevention can’t be prioritized and integrated into sanitation protocols. Fortunately, it’s possible to prevent biofilms in a more efficient way that saves time and money.

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Regulatory Requirements for Sanitation

Enacted in 2011, the Food Safety Modernization Act (FSMA) ushered in changes intended to protect public health by creating a food safety system based on prevention.1 For the food processing industry, the law includes:

  • Mandatory written preventive control plans.
  • Minimum produce safety standards.
  • FDA inspections at least every three years.
  • FDA access to food safety plans and other records.
  • Food testing by accredited laboratories.
  • FDA authority to issue a mandatory recall.
  • Enhanced product tracing capabilities.

Two years after the FSMA was signed, the FDA proposed two sanitation-focused initiatives: Hazard Analysis and Risk-Based Preventive Controls (HARPC) regulations and updated Current Good Manufacturing Practices (CGMPs).2 Finalized in 2015, the rules require food processing facilities to have a written food safety plan that analyzes potential hazards, implement preventive controls to minimize or prevent those hazards, and maintain documentation to ensure the efficacy of sanitation procedures.3

Enacted in 2011, the Food Safety Modernization Act (FSMA) ushered in changes intended to protect public health.

The update to CGMPs made certain previously optional activities mandatory, including:

  • Training in the principles of food hygiene and food safety.
  • Maintaining records of training.
  • Employing procedures to control allergen cross-contact.
  • Using sanitation controls to prevent hazards.
  • Implementing a risk-based supply chain program.
  • Having written recall plans.

Sanitation controls are processes that ensure the facility is maintained in a sanitary manner to control environmental pathogens. Monitoring is also required if contamination of a ready-to-eat food with environmental pathogens is a hazard.4

For many FSQAs, these regulatory changes required the development of new processes and systems, including sanitation protocols.




Cost of Contaminations and Food Recalls

Food safety is not just a public health issue; it is also a financial issue. In 2010, the Pew Charitable Trusts and the Produce Safety Project at Georgetown University published a report estimating the annual economic impact of foodborne illness in the United States to be around $152 billion.5 In 2015, the USDA Economic Research Service estimated that the annual economic burden had decreased to $15.5 billion.6 Although there are costs associated with implementing new sanitation controls, according to the FDA, the measures outlined in the FSMA will help the industry save $2 billion per year and prevent around one million illnesses.7

The economic burden of foodborne illness also has an impact on food processors. One report commissioned by the Food Marketing Institute and the Grocery Manufacturers Association indicates that the average direct costs related to a food recall total $10 million.8 This includes expenses related to assembling a crisis team, removing products from the market, investigating the cause, and managing public relations. However, the indirect costs can also add to the tally when a product is recalled. These might include lost efficiency and production in the facility, lost business, litigation, fines, and a decrease in stock value.9

Food safety is not just a public health issue; it is also a financial issue.

Brand damage is another potentially devastating cost that is more difficult to quantify. A food recall affects consumer trust and can have a lasting impact on a brand’s reputation. A Harris Interactive poll indicated that 55 percent of consumers would temporarily switch to another brand, 15 percent would never purchase the recalled brand again, and 21 percent would avoid using any brand made by the manufacturer.10 Based on this information, it’s clear that a food recall can cause lasting damage to a company’s brand identity.


Common Pathogens in Food Processing Plants

Understanding which pathogens are most commonly found in food processing plants is an important part of preventing an outbreak.

Escherichia coli (E. coli)

E. coli are bacteria that live in the intestines and are generally harmless. However, certain types of E. coli can cause gastrointestinal illness ranging from mild to severe cases. Infections can spread when wildlife or livestock contaminate meat or food crops, or when food handlers don’t use proper hygiene practices.11

Salmonella enterica

Salmonella bacteria cause the foodborne illness salmonellosis. The CDC estimates about 1 million people in the US get sick each year from this illness. Salmonella spreads through consumption of raw or undercooked meat, poultry, dairy, eggs, or food that has been contaminated by touching surfaces with the bacteria on it.12

Listeria monocytogenes (L. monocytegenes)

Listeria is a disease-causing bacteria that can survive under refrigeration and lives in soil, water, meat, and produce. The bacteria are transmitted during food harvesting, processing, packing, transportation, and storage when contaminated materials enter the environment through soil, water, and air.13



Biofilms are complex microbial ecosystems comprised of one or more species of microorganism that form in an extracellular matrix of polysaccharides and attach to a surface. This matrix provides a structure that makes it difficult to remove the biofilm while also providing nutrients and protection for the bacteria within it. Biofilms can develop on a range of surfaces, including stainless steel, polyethylene, wood, glass, polypropylene, rubber, and more.14

Biofilms present many challenges to FSQA managers. They are not visible to the naked eye, they may contain multiple bacterial strains, they are persistent, and they are difficult to remove once formed. One of the most common ways to remove them is through mechanical action, which is both labor-intensive and difficult to do on every surface in a processing facility. Because of this, master sanitation schedules will often break up mechanical action on different areas of the plant over days or weeks in order to cover surfaces from wall to wall and from floor to ceiling. Because of the physical challenges inherent to mechanical action, hard-to-reach places are often overlooked, including ceilings, areas in between machinery, and drain systems.




Drain systems are particularly susceptible to biofilms because the drains in many processing facilities are not designed for food contact. Without proper sanitation, bacteria collects and grows within the drains and finds its way back onto the floor through cross-contamination. One of the most famous cases of food contamination caused by the presence of biofilms in the drain system was the massive recall by Blue Bell ice cream in 2016.15

Once removed, biofilms can grow back unless they are killed at the DNA/RNA level. Wiping away a biofilm does not necessarily eradicate it completely. When it comes to food safety, it’s important for sanitation teams to understand the differences between cleaning, sanitizing, and disinfecting and the processes and products that are related to each method. Cleanliness and sanitation help prevent the formation of biofilms, but disinfection is required to effectively destroy bacteria once a biofilm has formed. The matrix surrounding a biofilm can protect it from cleaners and sanitizers; disinfection is required to completely eradicate it. However, regular sanitation can help prevent the formation of biofilms by removing the majority of bacteria present.


Best Practices for Plant Sanitation

Good sanitation practices are some of the most cost-effective methods for preventing outbreaks. Investing the necessary time and resources in prevention can potentially save tens of millions of dollars by avoiding costly food recalls and the lasting brand damage that ensues. Many plants use some version of a proven, seven-step cleaning and sanitation process for delivering a plant that is  free of bacteria.16

1. Inspection, identification, equipment breakdown

Break down equipment and inspect it to identify areas that
need particular attention. Based on this assessment, select
the appropriate application methods and chemicals. Although
there are often standard protocols, this is an important step to
determine whether any additional measures are needed.

2. Sweeping and flushing

Physically remove gross solids and large particles with brooms, scrapers, and other cleaning tools. Removing food residues helps keep the wash water cleaner throughout the process. Flush or rinse surfaces with warm water to remove as many solids and particles as possible.

3. Washing

Apply a detergent either manually or with a mechanical foamer. Follow the manufacturer’s directions for dilution rates and contact times. Physically scrub the surfaces to help remove particles that have adhered to surfaces. When operating in a dry facility, use alcohol or other solvents that evaporate over time.

4. Rinsing

Remove the detergent with a potable water rinse. All detergent must be removed to prevent the formation of residues that may neutralize sanitizers. Many plants also complete an ATP testing validation step after rinsing to measure the effectiveness of the cleaning process. If the test results are over a certain limit, the equipment should be cleaned again.

5. Sanitizing

Use the sanitizing process that is most applicable to the equipment and surfaces being sanitized and the bacteria being
treated. This might include heat, bleach, quaternary ammonium compounds, peracetic acid, hydrogen peroxide, or other chemical sanitizers. When using chemical sanitizers, follow the manufacturer’s directions for concentration and contact time.

6. Rinsing again/air drying

Depending on the type of sanitizer used, it will either have to be rinsed with potable water or left to dry on surfaces. When using rinse-off sanitizers, ensure that surfaces are thoroughly rinsed prior to resuming operations. For leave-on sanitizers, follow the manufacturer’s directions regarding dry time.

7. Validation

After cleaning and sanitizing, validation is conducted through
visual inspection and protein swabs to test for the presence of
bacteria. No visible residue should be present, and microorganism counts must be within the defined acceptable limits.

Although it might seem simple on paper, this seven-step process can be time consuming, labor-intensive, and expensive. To make matters more challenging for FSQA managers, even when all of these steps are completed correctly, bacteria-positive tests can still occur, especially when persistent biofilms are present.





Preventive Solutions

Avoiding biofilms in the first place is one of the best ways to maintain plant efficiency and prevent costly recalls.

How can you have a plant where biofilm is nonexistent?

First, be mindful of bacteria sources. High-traffic areas, pallets, forklifts, and other mobile equipment can transport bacteria between areas in a facility. Treat those areas and the equipment in them to prevent contamination. To prevent cross-contamination, many plants regularly apply a granulated quaternary ammonium compound to the floor to help address Listeria and Salmonella. This is effective for preventing growth, but it does not eradicate their presence. Establish a regimen that includes daily sanitation to help prevent the formation of biofilms. Perform weekly testing for common bacteria to identify outbreaks and locations of contamination.

When selecting sanitizers, consider the time and effort required to apply them and the potential drawbacks associated with them. Many major players in the sanitation industry recommend rotating various chemicals on different schedules to protect machinery and prevent bacterial resistance. The disadvantages of this approach are that it can get expensive, often requires labor-intensive mechanical action, and requires purchasing and storing multiple different chemicals. Additionally, when bacteria isn’t completely eliminated down to the DNA level, it can grow back stronger and become resistant to cleaning chemicals. This creates a need for even more cleaning chemicals, which is not a sustainable strategy.

How can you be sure the plant is completely sanitized without mechanical action?

Another approach is to use a single chemical solution that requires less manpower to completely eliminate bacteria and biofilms. Appropriate for both deep cleaning and daily and weekly schedules, D7 is an EPAregistered cleaner, sanitizer, and disinfectant that can be applied as a liquid, foam, or fog and does not require mechanical action. This means that you can effectively sanitize every surface in a processing plant on a regular basis with a single chemical and less manpower. D7 is proven to be effective against E. coli, Listeria, and Salmonella, and studies have shown it to be effective against biofilms,17 making it a smart choice for FSQA managers seeking a single preventive solution to some of the most common foodborne pathogens.

D7 is an EPA registered cleaner, sanitizer, and disinfectant that can be applied as a liquid, foam, or fog.





What to Look for When Choosing a Vendor

Regardless of which preventive solutions you employ, it’s important to work with vendors who provide support to ensure that the products are being used correctly and effectively. Many chemical suppliers are primarily focused on product sales and do not necessarily have the expertise to help you overcome sanitation challenges. On the other hand, some manufacturers offer training and ongoing support to help sanitation teams prevent and address outbreaks.

When deciding which vendors to work with, ask these key questions to determine whether they will be a trusted partner or just another supplier:

  • What bacteria does your product kill?
  • How is the product applied and at what concentration?
  • How does the product affect plant and equipment surfaces?
  • What steps do you take to ensure the product is used effectively?
  • Who can I talk to about specific bacteria issues?
  • Do you have field personnel who will train my team?

When evaluating a particular product or vendor, take the time to test equipment surfaces both before and after application to assess the effectiveness of the product you are considering.

Take the time to test equipment surfaces both before and after application.





Why D7 is the Smart Choice for Busy FSQA Managers

With D7, you can remove biofilms in a food processing plant with a single chemical solution and no mechanical action. When you decide to try D7, a team of field technicians will visit your site to evaluate your specific needs. This personalized attention means that the challenges you are facing are directly addressed, removing the guesswork and allowing you to create the most effective sanitation protocols for your facility and equipment.

D7, which is an EPA-registered product, was born from military research and has been tested and validated by academia, government, and third-party labs. It has also been repeatedly proven in plant environments by existing customers. D7 is already used by some of the largest players in the food processing industry and is rapidly being adopted by companies of all sizes. Whether you are being proactive by implementing preventive practices or are urgently responding to an outbreak, a team of experts is available to help you through it.

When you decide to try D7, a team of field technicians will visit your site to evaluate your specific needs.




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