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Patent Granted for Sterilex Ultra Step

Sterilex Ultra Step Patented

The US Patent and Trademark Office has granted Sterilex a patent for its surface treatment product, Sterilex Ultra Step. The patent, originally filled under patent application 20180105773, covers a unique method for surface treatment powder activation.

More About Sterilex Ultra Step
Sterilex Ultra Step is based off of Sterilex’s PerQuat® chemistry and is one of the few EPA-registered solid floor treatment products currently on the market. It is most commonly used for entryway control in heavily trafficked areas, as well as in doorway floor mats. With low moisture activation requirements, Sterilex Ultra Step is an ideal fit for dry processing facilities and other facilities looking to reduce water usage. It is also well suited for biosecurity applications on poultry and swine farms.

Sterilex Ultra Step is EPA approved to eliminate Enterobacter, E. Coli, Listeria, Salmonella enteritidis, Salmonella enterica, and Avian Influenza among other organism when used in compliance with label instructions.

Interpreting an EPA Label: Sanitizer vs Disinfectant

Environmental Protection Agency (EPA), regulates all antimicrobial product labels and any associated efficacy claims. The language and claims contained on each label must be supported with extensive scientific data that is submitted to EPA in the pesticide registration approval process. These labels govern usage rates, applications and directions for use. End users of chemicals must ensure compliance with the label and should understand the meaning behind differing label claims. This is the first in a series of posts that will look at EPA label language and what it means to the end-user.

Definitions
The words sanitizer and disinfectant are often used interchangeably in the food processing industry. The Environmental Protection Agency (EPA), however, has distinct definitions for each term.

Sanitizer: a substance, or mixture of substances, that reduces the bacteria population in the inanimate environment by significant numbers, but does not destroy or eliminate all bacteria.

Disinfectant: a substance or mixture of substances, that destroys or irreversibly inactivates bacteria, fungi, and viruses, but not necessarily bacterial spores, in the inanimate environment.

Source: EPA Website, 40 CFR 158.2203

Definitions in Practice
For commercial products, this simply means that disinfectants provide a higher level of demonstrable microbial load reduction than sanitizers. Product performance guidelines are outlined by EPA in Product Performance Test Guidelines OCSPP 810.2300 (sanitization) and OCSPP 810.2200 (disinfection). These guidelines are summarized in Table 1, with minimum surface contact times indicated in parentheses.

  Sanitizer Disinfectant
Microbial Load Reduction:
Non-Food Contact Surfaces
3 log
99.9% (5 min)
6 log
99.9999% (10 min)
Microbial Load Reduction:
Food Contact Surfaces
5 log
99.999% (30 sec)
6 log
99.9999% (10min)
Fungi & Viral Control NO YES

On the Label
In some instances, the same product can be both a sanitizer and a disinfectant when used at different concentrations, or on a different surface, or with longer surface contact time. Sterilex® Ultra Disinfectant Cleaner Solution 1 is an example of this type of product when used with Sterilex® Ultra Activator Solution.

The label for Sterilex Ultra Disinfectant Cleaner Solution 1 (EPA Reg. No. 63761-8, accepted 9/22/16), contains a claim that allows the product to be used as both a rinsed disinfectant on food contact surfaces, and as a non-rinsed surface sanitizer on non-food contact surfaces. This section of the label is highlighted below.

DISINFECTION AND NON-FOOD CONTACT SURFACE SANITIZATION OF FOOD PROCESSING EQUIPMENT AND HARD SURFACES IN FOOD PROCESSING FACILITIES: Apply Sterilex Ultra Disinfectant Cleaner Solution 1 and Sterilex Ultra Activator Solution as a disinfectant, per General One Step Disinfection and Cleaning Directions, or as a sanitizer, per General Sanitization Directions. Use product within 8 hours of mixing Sterilex Ultra Disinfectant Cleaner Solution 1 and Sterilex Ultra Activator Solution.

“Disinfection” and “non-food contact surface sanitization” are separate statements and claims, an important differentiation. Per Food and Drug Administration (FDA) requirements, a no-rinse sanitizer must be used on food contact surfaces as the final step prior to production. For this reason, Sterilex specifically differentiates between disinfection claims (followed by a rinse) on food contact surfaces, and non-rinsed surface sanitization claims for non-food contact surfaces.

Therefore, on food contact surfaces, this product has demonstrated an ability to kill ≥ 6 logs of the organisms on its label on food contact surfaces, whereas products marketed as sanitizers on food contact surfaces have demonstrated an ability to kill at least 5 logs of the organisms on their label on food contact surfaces.
Please see the product label for complete directions for use.

Conclusion
Both EPA registered sanitizers and disinfectants can effectively reduce or remove bacterial load from surfaces in food processing facilities. However, when used in accordance with the label, disinfectants offer processing facilities a more complete inactivation/removal of microbial load than sanitizers.

See product label for full label claims and usage instructions.

Sterilex Announces New President

Alex Josowitz, President of Sterilex

On July 5th Sterilex announced the promotion of Alex Josowitz to the position of President. As President, Alex will have responsibility for the organization’s operational functions and will play a key role in the company’s strategic direction.

“I am excited and honored to take on this new role and look forward to working with our talented and growing team to continue to drive innovation, sustain growth and develop value-added products for our customers,” said Josowitz.

Alex has worked at Sterilex for 12 years, taking on a variety of sales, marketing and operational leadership roles. Most recently, Alex served as Executive Vice President, Business Development and Operations where he displayed strong sales and operational leadership and oversaw a period of rapid growth, highlighted by the expansion of Sterilex’s brand and portfolio of award-winning products for microbial control and detection.

Concurrent to Alex’s appointment, Dr. Shira Kramer, Sterilex’s founder, will remain as CEO and Chairwoman. As founder and past President, Shira led the business and was instrumental in strategic leadership, obtaining key regulatory claims, new product innovation, and commercialization. In addition, she led the sustained growth of many key markets and has played an important role in establishing the brand as it is today.

“Alex’s efforts can be directly seen in the results,” said Dr. Kramer. “With his leadership, ability to deliver results and strategic thinking, Alex is the ideal candidate to execute Sterilex’s strategic key business initiatives and drive sustainable growth,” Dr. Kramer stated.

The Importance of Periodic Equipment Cleaning

Periodic Equipment Cleaning ImageAlthough sanitation occurs on a regular basis, that alone may not be enough for difficult to disassemble or difficult to clean equipment and surfaces. Periodic, intensified cleaning can be used to address these challenges without adding steps to the daily sanitation program. Sterilex delivers award-winning EPA registered products and onsite industry expertise to help build and enhance food safety and sanitation programs. To learn more about the importance of periodic equipment cleaning, read this informative article from Food Safety Magazine, or contact your Sterilex representative about how Sterilex products can be integrated into periodic cleaning programs.

Frozen doesn’t mean Listeria – Free

The food industry has been increasingly focused on a risk-based approach to food safety. Control of Listeria specifically, is always at the top of every list, as it poses the largest threat. “The pathogen’s recent influx in a variety of fresh, frozen and processed foods is reinforcing the importance of understanding how contamination occurs in processing plants.” (Mackin, 2018).

While most frozen foods are meant to be cooked, it is not uncommon for the average consumer to use frozen fruit and vegetable products in cold salads, and other prepared foods consumed without cooking first. Benjamin Chapman, a food-safety specialist and an associate professor at North Carolina State University noted, “Though eating raw, frozen vegetables may sound unusual, frozen kale, for example, is increasingly being used in smoothies. And it’s not uncommon for pediatricians to recommend letting young children chew and suck on frozen veggies while teething.” (quoted in Miller, 2016). Chapman went on to clarify that although freezing may stop Listeria growth, it doesn’t necessarily kill the organism (Miller, 2016).

As frozen food processors evaluate risk, and implement changes, the freezers themselves present unique challenges:

  • Design- there are many areas of freezers that are difficult to reach or are inaccessible. Due to the size of the units, they cannot be disassembled completely for a thorough cleaning. Freezer coils tend to be difficult to reach, difficult to clean, and expensive to replace if damaged.
  • Compatibility- Many freezers are made of metals such as aluminum that can be easily damaged by common products used for cleaning and sanitizing. As the damage occurs, it creates even more harborage points for microorganisms and additional cost for the processor.
  • Temperature- As the freezer is defrosted for thorough cleaning, the warmer temperatures allow existing Listeria to grow. The condensation created from the thaw can also contaminate other surrounding surfaces.

How can this be addressed? The industry is working toward better equipment design, not just for freezers, but for all equipment used in food manufacturing.
Additionally, the industry has recognized the need for cleaning and sanitizing chemicals that are effective in addressing the shortcomings of current equipment design, and products that are compatible with aluminum and other soft metals.

Sterilex Ultra Disinfectant Cleaner Solution 1 and Ultra Soft Metal Activator is a disinfection chemistry specifically designed to kill specific organisms such as Listeria as well as remove biofilm* on aluminum surfaces. It can be used to safely disinfect freezer surfaces while moving into inaccessible areas where biofilms are harbored.

Miller, Sara G. “Listeria in Your Freezer: How Long the Bacteria Survive.” LiveScience, Purch, 25 May 2016, www.livescience.com/54882-listeria-outbreak-frozen-foods.html.

Mackin, Kelsey M. “South Dakota scientists target Listeria in food processing plants.” Food Safety News, 14 Feb 2018, http://www.foodsafetynews.com/2018/02/south-dakota-scientists-target-listeria-in-food-processing-plants/#.WoTDsK6nHIV

*Biofilm label claims approved for specific applications only. See product label for full label claims and usage instructions.

Clean Surfaces Provide ROI for Dairy Producers

Whether dairy producers are raising their own calves, or contract raising for others, animal health is a top priority. Healthy calves lead to lower veterinary and death loss expenses, and ensure that a viable replacement heifer is entering the herd.

Part of raising healthy calves is maintaining a healthy environment, and feed sources that are free from pathogens that cause illness. A recent article published in Hoard’s Dairyman highlighted the risks of biofilm growth in calf feeding equipment.¹ When bacteria form a biofilm, they become resistant to many of the common methods used for sanitizing calf equipment, such as bleach dips. The surviving bacteria, harbored in a biofilm can then lead to an increase in scour days, reduced growth efficiency, and sometimes death.

Sterilex’s proprietary PerQuat® technology was specifically designed to break-up bacterial biofilm and kill resistant micro-organisms.* Sterilex is the only company with products approved to remove biofilm on both public health and industrial surfaces.* Sterilex’s patented line of products can also be used to disinfect hard surfaces such as calf huts and feeding equipment to aid in reduction of illness and disease transfer.

*Biofilm label claims are approved for specific applications only. See product label for full label claims and usage instructions.
1. Seiler, Maggie. “Break away from biofilm contamination.” Hoards.com. Dairyman, 31 July 2017. Web. 8 August 2017

FDA perspective on “Seek and Destroy”

The development and implementation of the Food Safety Modernization Act (FSMA) signals a concerted effort to improve food safety in FDA inspected plants, and implement some of the same structure and oversight as seen in USDA inspected facilities.

In January of 2017, the FDA released an updated guidance document outlining their guidelines for Listeria control in ready-to-eat (RTE) food processing facilities. This new document “supports ongoing efforts by industry and government agencies to reduce the risk of Listeria monocytogenes (L. mono) in RTE foods. L. mono, a pathogen that can grow even in cold, refrigerated environments, is particularly harmful to the elderly, pregnant women and/or their pregnancy, and those who are immunocompromised.” [1]

The document, meant to expand upon the requirements for management of risk, and development of preventative controls outlined in FSMA, covers risk analysis and encourages food processors to expand their environmental monitoring programs. “Industry best practices and the “seek and destroy” approach used by the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) have been incorporated into the draft guidance.” [1]

Adam Borger of the University of Wisconsin-Madison Food Research Institute, spoke of the new guidance, saying, “I am a proponent of what the FDA is recommending in their draft guidance regarding sampling of food-contact surfaces for Listeria genus.  I feel that giving food processors the ability to sample food-contact surfaces for Listeria genus without absolutely having to place all product on hold until the result is returned, will encourage a more aggressive sampling plan to find and eliminate Listeria and niches where the microbe may persist.” [2]

Multiple tools can be used in a robust environmental monitoring program. Technologies such as Sterilex’s Indicon™ Gel can be used to rapidly detect biofilm harborage niches and track sources of contamination in seek and destroy applications. While traditional swabbing methods can be used to verify the absence of organisms on a “swab-able” surface, Indicon Gel can be used to identify harborage points in areas only a gel can reach, and provide rapid, visual results in a cost-effective manner*.

  1. https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm536716.htm
  2. Borger, Adam C. University of Wisconsin-Madison, Food Research Institute. 26 May 2017

*The lack of a positive reaction from Indicon Gel does not guarantee that the surface is free from microorganisms.  Indicon Gel is not meant to take the place of routine microbial monitoring or organism-specific diagnostic tests.

Sterilex Technology and Aiding the Prevention of Avian Influenza Outbreaks

This week the United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) confirmed the presence of highly pathogenic H7 avian influenza in a commercial chicken breeder flock in Lincoln County, Tennessee.

Using Sterilex® Ultra Disinfectant Cleaner Solution 1 and Sterilex® Ultra Activator or Ultra Soft Metal Activator, effectively controls Avian Influenza (AI), multiple strains of Salmonella as well as numerous additional poultry and swine pathogens.  In waterlines, it can be used for line disinfection and the removal of organic contaminants. The two-part solution is mixed, diluted in water, pumped into the nipple drinker lines to soak, and then flushed with potable water between flocks. This process creates a cleaner, safer water source and limits the risk of AI spreading between flocks.
Sterilex Ultra Disinfectant Cleaner Solution 1 and Sterilex Ultra Activator Solution, or Ultra Soft Metal Activator, can also be used inside barns to disinfect between flocks. Following the removal of gross soils from the barn, the two-part solution is mixed, diluted in water, and either foamed or sprayed on surfaces.

For additional biosecurity solutions, Sterilex offers Sterilex® Ultra Step.  This non-slip blue powder is an EPA-registered floor surface, floor mat, foot pan and boot sanitizer approved to kill organisms such as Listeria, Escherichia coli (E.coli), Salmonella, Staphylococcus (Staph), and Enterobacter. Used in entryways, Sterilex Ultra Step can also control organism transfer from foot traffic and equipment movement. Apply directly to floors in barns and hatcheries to prevent the spread of harmful pathogens.

Visit www.sterilex.com  for more information about using Sterilex products to enhance biosecurity programs.

  1. https://www.aphis.usda.gov/aphis/newsroom/news/sa_by_date/sa-2017/hpai-tn

Sterilex and FSMA Compliance

As of Sept 2016, FSMA, the Food Safety Modernization Act is in full effect. For food manufacturers, the implications of reaching compliance, are immense. One of the key components of compliance is the requirement for preventative controls. Although this is a broad topic, it can be summarized in three sections, Hazard Analysis, development of preventative controls, and finally management of the preventative control protocols that have been created [1].

The process of implementing preventative controls begins with determining what potential hazards exist in the processing environment, or are created by the actual process. The FDA draws no distinction between hazards that are introduced intentionally and those that are naturally occurring. For example, Listeria contamination due to the natural soil residue on incoming produce would still be considered a hazard that must be noted and addressed. From a sanitation perspective, limiting pathogen movement and recognizing pathogen harborage points in the processing environment are essential.

After processors know where hazards exist, they must create a written food safety plan for addressing all the hazards [2]. That plan, must then be managed as new hazards are presented, or the process changes. A critical part of the creation and implementation of preventative controls is verification. This includes, “Validating with scientific evidence that a preventive control is capable of effectively controlling an identified hazard.” [1].

In identifying the proper controls to put in place, manufacturers must identify adequate chemical interventions to address hazards in the processing environment. Sterilex offers a full line of EPA registered sanitizers and disinfectants that are proven to be effective in removing biofilms, which are a hazard created by harborage points on equipment or in the environment. EPA registered sanitizers such as Sterilex Ultra Step, go through exhaustive testing that meets the demand for “scientific evidence” of the capability to control organisms such as Listeria, Salmonella, and E. coli. As an EPA registered sanitizer Ultra Step is legally approved to be included in the processor’s food safety plan. As processors and sanitation experts collaborate to meet the preventative control requirements of FSMA, the Sterilex product line provides much needed solutions.

  1. https://www.fda.gov/food/guidanceregulation/fsma/ucm334115.htm
  2. http://www.foodsafetymagazine.com/magazine-archive1/octobernovember-2015/hazard-analysis-and-risk-based-preventive-controls-harpc-the-new-gmp-for-food-manufacturing/

2016 Listeria Recalls Higher Than Past Three Years

Food product recalls due to Listeria contamination continue to capture the attention of processors, regulators, and especially, consumers.  According to the USDA’s Food Safety and Inspection Service, the number of Listeria-related recalls for 2016 were more than those reported for the past three years.

listeriarecallMeat processors today are experiencing great success with controlling pathogens on incoming products.  However, with value-added goods in high demand, risk for contamination increases as more surfaces, equipment and hands come in contact with food product throughout the process. Food processors must remain vigilant with best practice sanitation programs in place to address the introduction, growth and transfer of pathogens in the processing environment.  As the FDA intensifies pressure, in an effort to catch-up to FSIS protocols, some processors are searching for new ways to meet regulatory expectations for prevention of Listeria.  One idea calls for greater information share in the ongoing battle to control and eliminate Listeria.

Mitigation of Listeria requires removal of biofilm and subsequent prevention and control afterwards in food production environments. The most effective preventative control programs develop a holistic approach, looking at all areas that contribute to transfer and movement of pathogens such as foot traffic and shared equipment.

Sterilex® Ultra Powder has been designed as a unique EPA-registered floor sanitizer for use in food processing and animal environments, and is now the leading product in this market segment.   This innovative product utilizes Sterilex proprietary PerQuat® technology, and incorporates unique features such as small, non-slip granules that plant workers can broadcast directly on plant floors to sanitize and enhance traction.

What additional information is available?

For more on this topic, read the in-depth article in the October issue of Meatingplace.

To learn more about Sterilex products and how they address the challenges that food processors face today visit www.sterilex.com.

*Biofilm label claims approved for specific applications only. See product label for full label claims and usage instructions.
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