By Joe Curran

To succeed today, food and beverage producers know they must meet four objectives: 1) produce safe, high-quality products, 2) operate efficiently, 3) increase profitability, and 4) reduce water, energy, and waste.

They also know that to achieve these objectives, they can’t overlook clean in place (CIP). If CIP is not done well, producers risk contaminated products, production downtime, higher costs, and increased natural resource consumption. Further, poor quality and product recalls can damage brand reputation, lead to litigation and undermine hard-earned customer, consumer, and shareholder trust.

However, the challenge with CIP is evaluating how—and how well—it cleans at each wash. It’s like an old friend who, after years of friendly give and take, still holds tight to his secrets.

The industry has certainly tried to peer beneath the surface to learn what’s really going on during the CIP process. Periodic manual evaluations have provided helpful snapshots of CIP performance, but they could not be used to validate effectiveness across all washes. Increasing the frequency of manual evaluations to truly meaningful levels has simply not been practical.

In addition, when Programmable Logic Controllers (PLC) coupled with field instrumentation, advanced Human Machine Interfaces, and electronic Historian Databases became the standard of control within CIP operations, the industry expected greater insight into CIP performance. These technologies did generate reams of data. But developing platforms that could translate it into actionable insights required special expertise and considerable expense. In the end, the data offered limited practical value for understanding CIP performance.

With no good way to assess each clean, QA and plant operations teams have taken it largely on faith that CIP activities are being performed as intended. When Ecolab, which has partnered with fluid flow processors to enhance this sanitation technology for over 55 years, asks customers what percentage of the time they believe their CIP washes are done correctly, they usually answer “around 100 percent.”

Such assumptions can be risky. For instance, when Ecolab installed an automated CIP monitoring system at several customer locations, only 30 to 50 percent of washes were running optimally. So far, the absolute best rate of conforming washes the company found has been between 60 and 70 percent. Non-conforming washes suggest trouble on one of two fronts: either resources are being wasted (too much water and/or chemical) or food safety is at risk (too little water and/or chemical.) Of the two, the impact on quality has been far and away customers’ top concern. Resource use and associated costs have been a distant second.

Recently, the quest for effective, comprehensive CIP monitoring has taken a promising turn, thanks in large part to the Internet of Things and big data. The marriage of these two thoroughly modern inventions has led to systems capable of monitoring CIP washes 24/7 and providing specific insights into current and emerging CIP performance problems.

These advanced automated monitoring systems collect real-time CIP process data from the customer’s industrial network (PLC and/or Historian Database), encrypt it, and transmit it to data centers where the data is aggregated. Sophisticated algorithms then scour the data for patterns and deviations that indicate compliance or non-compliance with prescribed wash protocols. Importantly, these algorithms are designed to translate the data in a CIP context to help ensure the relevance of the output.

Data analytics experts provide further interpretation of the data to discern problems that need immediate attention—and opportunities for future improvement. Ultimately, the analysis separates the “critical” from the merely “interesting.” With such clarity, recommendations can be developed to address immediate and long-term challenges.

Armed with actionable recommendations, internal and external technical teams can waste no time getting to the most urgent issues. In fact, for greatest impact, all data analysis should lead to action plans that can be incorporated in the plant’s service platform.

From Transparency Comes Impact

Food and beverage producers who have implemented these 24/7 automated CIP monitoring systems report positive impact on quality and operational metrics, as seen in the following examples.

Over 12 months, the Kemps fresh milk plant, Rochester, Minn., using Ecolab’s 3D TRASAR for CIP Technology, reported improvements in the following:

• Product quality as monthly variability in percent passing decreased by 55 percent from 2013 to 2014 and average percent passing end of code increased by 1.1 percent from 2013 to 2014;
• 1,295 hours of cleaning time saved;
• 963,750 gallons of water used for cleaning conserved;
• 1215 kWh electricity saved and 1,847 pounds of carbon dioxide emissions avoided (Calculated from www.epa.gov/cleanenergy/energy-resources/calculator.html); and
• 3,000 gallons of CIP chemical usage reduced.

Over three months of 24/7 CIP monitoring, another large beverage producer found a flow imbalance during the cleaning of its fillers. After making needed improvements identified by monitoring one line, the plant reported annualized efficiency benefits, including:

• 200 hours reduced cleaning time;
• 875,000 gallons reduced water consumption for cleaning;
• $8,000 cost avoidance through reduced pump and valve maintenance; and
• $369,000 total estimated benefit gained from identifying problems with 24/7 monitoring.

In addition, over a three-month period in which just 20 percent of its CIP activity was monitored, a large food producer identified opportunities to realize savings valued at $230,000. More important, round-the-clock monitoring found ineffective sanitizing methods occurring at a rate that could have negatively impacted the quality of approximately 1,800 production batches each year.

What to Expect of Automated CIP Monitoring

Automated CIP monitoring systems should answer three simple questions: 1) Did you clean everything you were supposed to clean? 2) Did you clean everything the way it was supposed to be cleaned? 3) Did you clean optimally?

If the technology can’t respond with clear answers, it’s probably not for lack of data. Rather it’s likely due to the system’s inability to distill the data to a level that is useful. Too much information with too little interpretation is more frustrating than no information at all.

To assure that “yes” is the answer to the three questions day after day, a three-phase approach is recommended once an automated monitoring system is installed.

• Standardize. During this phase, the aim is to make needed adjustments to CIP protocols to achieve at least 90 percent of washes done correctly (as mentioned before, the best Ecolab has seen is 60 to 70 percent). Creating consistency around CIP operations has an immediate, tangible impact on quality while also improving efficiency. Once washes are standardized to perform correctly and consistently, it’s time for Phase 2.
• Optimize. In this phase, the goal is to identify savings opportunities to further optimize washes. Ultimately, the focus should be to drive wash conformance rate upward to 100 percent.
• Sustain. With CIP, many things can, and do, change as wash recipes are added and adjusted. Automated CIP monitoring should be an ongoing and well integrated component of operations to ensure sustained wash conformance—as well as consistent product quality and safety for the long term. Continuous monitoring also enables organizational learning as it yields insights and best practices that can be shared.

Of course, easy access to the results of 24/7 CIP monitoring is essential. Advanced systems feature online dashboards with scheduled and exception-based reporting, as well as access to comparative analysis (historical, relative, and best-case). They use phone, email, and text to alert you—and your service and support teams—to the need for action when immediate problems arise.

Having CIP performance data at your fingertips provides another important benefit: It helps you prepare for compliance with the Food Safety and Modernization Act (FSMA). FSMA requires extensive documentation and recordkeeping related to QA and control processes. Companies that cannot readily produce the required documentation could face inspections, fines, and even recalls. CIP monitoring reports will help avoid these and other regulatory pitfalls.

Constant Assurance

CIP has long been a tight-lipped introvert. But with automated CIP monitoring systems, it’s becoming a babbling extrovert, pointing to problems that need quick action and suggesting opportunities to improve metrics or avoid catastrophe.

The transformation is astonishing, and it is not yet complete. As monitoring technologies continue to advance, look for CIP to become smarter, perhaps even intelligent.

Today, CIP is prescriptive. It takes direction on when and how to wash—and then it does the job. In the coming years, CIP will take direction on when and how to wash based on production. Further in the future as digital technologies provide an even more comprehensive view of production and cleaning performance, expect CIP to become “predictive,” cleaning only when, and as much as, needed. These leaps forward will make CIP an even better partner in product quality and food safety.

Before you think about tomorrow, though, it’s important to appreciate where CIP is today. Automated CIP monitoring is taking much of the guesswork, and worry, out of quality and food safety by providing constant assurance that every wash is confirmed and validated. The advantages are unmistakable:

• Anomalies are found immediately, and action can be taken to mitigate food safety impact;
• Risks are more apparent and better understood;
• Processes and applications can be optimized;
• Operational choices, and how they affect one another, can be evaluated; and
• Outcomes can be improved.

More than ever, food and beverage producers can be proactive in preventing risks. And more than ever, they can be assured that CIP is supporting, not undermining, their quality, safety, profitability, efficiency, and sustainability objectives.

By Allan Pfuntner, M.A., REHS

In the food industry, chemicals are routinely used to sanitize and disinfect product contact surfaces. These chemicals provide a necessary and required step to ensure that the foods produced and consumed are as free as possible from microorganisms that can cause foodborne illness. Prevention is the name of the game. What are these chemicals, how do they function and how are they used?

Disinfecting Versus Sanitizing
Before discussing the chemicals, the differences between sanitizers and disinfectants as used in the food industry must be understood. To disinfect means to destroy or irreversibly inactivate specified infectious fungi and bacteria, but not necessarily the spores, on hard surfaces.[1] To sanitize means to reduce microorganisms of public health importance to levels considered safe, based on established parameters, without adversely affecting either the quality of the product or its safety.[2] While disinfection measures may be employed in food processing and preparation, it is much more common to utilize sanitization methods to reduce microbial presence.

To achieve the required level of sanitization or disinfection, the chemical in question must be applied at a certain concentration for a specified amount of time. These parameters are described on the product label and must be followed to achieve the desired microbial control. In most cases, these products are registered for use as pesticides with the U.S. Environmental Protection Agency (EPA). Once applied, the allowable residues and the monitoring thereof in food processing and preparation are the responsibility of the U.S. Food and Drug Administration. Facilities operating under the jurisdiction of the U.S. Department of Agriculture must additionally use products approved by that agency. Of course, the task of ensuring the chemicals are prepared and applied properly to avoid inappropriate residues rests with the food processor and foodservice operator.

The efficacy of a chemical used for sanitizing or disinfection rests upon its ability to reduce the contamination level. The sanitization standard for contamination reduction of food contact surfaces is generally accepted as 99.999% (a 5-log reduction) achieved in 30 seconds (Official Detergent Sanitizer Test).[3] The sanitization standard for nonfood contact surfaces is accepted as a reduction of 99.9% (3 logs) within 30 seconds. Disinfection, in contrast, must destroy or irreversibly inactivate all specified organisms within a certain time, usually 10 minutes. Some chemicals may function as both sanitizers and disinfectants.

The process of sanitization depends upon the preparation of the surfaces in question. Most sanitizers must be applied to surfaces that are free of organic matter and cleaner residues. The generally accepted order of events is rinse, clean, rinse and sanitize. The cleaner utilized in the cleaning step needs to be oriented and appropriate for the soil present. For example, alkaline detergents more efficiently remove fat- and protein-based soils, while mineral-based soils require acid cleaners. Thankfully, modern cleaning agents are mixtures of chemical components that can address various cleaning scenarios.

Sanitizing Chemicals
The food industry most often uses sanitizing procedures, so the information presented herein will focus on the more common products utilized. Regardless of the product, the sanitizing solution must be tested to verify that the desired concentration is consistently present. Too little sanitizer, of course, can result in unacceptable efficacy, while too much sanitizer can yield residues that do not meet standards.

Hypochlorites
Effectiveness, low cost and ease of manufacturing make hypochlorites the most widely used sanitizers. Sodium hypochlorite is the most common compound and is an ideal sanitizer, as it is a strong oxidizer.

Hypochlorites cause broad microbial mortality by damaging the outer membrane, likely producing a loss of permeability control and eventual lysis of the cell.[4,5] In addition, these compounds inhibit cellular enzymes and destroy DNA. Spores, however, are resistant to hypochlorites, as the spore coat is not susceptible to oxidation except at high concentrations coupled with long contact times at elevated temperatures.

While hypochlorites are very reactive, their useful properties are negatively impacted by factors such as suspended solids, high temperatures, light, water impurities and improper pH levels. In routine use, surfaces must be as free as possible of organic materials, and the pH must be maintained between 5 to 7 to ensure that the greatest amount of hypochlorous acid is available. As with any sanitizer, measurements must be taken periodically to make certain that the freely available chlorine is at the desired level. For no-rinse applications, the maximum allowable concentration of available chlorine is 200 ppm.

Other disadvantages of hypochlorites are corrosiveness to metals, health concerns related to skin irritation and mucous membrane damage and environmental contamination. The latter is of concern as chlorine can combine with organic substances to form toxic chlorinated compounds, such as trihalomethanes and dioxins. Hypochlorite use may be further restricted in the future. Care must be taken when cleaning hypochlorite spills as organic materials such as cloth, sawdust and paper may spontaneously combust upon drying.

Chlorine Dioxide
This inorganic compound is a broad sanitizer effective against bacteria, fungi and viruses. Chlorine dioxide is an oxidizer that reacts with the proteins and fatty acids within the cell membrane, resulting in loss of permeability control and disruption of protein synthesis.[6,7]

While chlorine dioxide is an explosive gas, it is relatively safe in solution. It is produced on-site as it can’t be compressed or stored commercially in gaseous form. Most chlorine dioxide generation is accomplished with complex systems. However, recent advances in formulation procedures allow the production of solutions of chlorine dioxide on-site without the use of expensive equipment.

Compared with hypochlorites, chlorine dioxide requires much lower concentrations to achieve microbial mortality. For example, a 5-ppm solution is effective as a sanitizer on food contact surfaces with a contact time of at least 1 minute. Further, disinfection can be achieved with 100 ppm using a contact time of 10 minutes.

Chlorine dioxide reacts more selectively with compounds present in microbial cells as opposed to reacting with organic compounds in general. This ability allows chlorine dioxide to function in more organically loaded solutions, though as organic load increases, efficacy does decrease. Chlorine dioxide functions well over a pH range of about 6 to 10, thus allowing increased mortality of some microbes at higher values. Another advantage is that chlorine dioxide does not form chlorinated organic compounds, making it more environmentally friendly.

Iodophors
These compounds are less active than hypochlorites but are effective sanitizers and disinfectants. Iodophors attach to the sulfurs of proteins such as cysteine, causing inactivation and cell wall damage.[8] Carriers with iodophor solutions allow a sustained-release effect, resulting in continuous microbial mortality.

Iodophors fare better in situations in which the pH is slightly acidic, as less active forms exist above neutral pH. The common concentration for sanitization is 25 ppm for 1 minute. Unfortunately, iodine compounds easily stain many surfaces, particularly plastics. On the plus side, they are common sanitizers used on glass surfaces, such as in the beer and wine bottling industries. The EPA has assessed iodophors as having no significant effect on the environment.[9]

Peroxyacetic Acid (PAA)
PAA is an effective sanitizer that is active against many microorganisms and their spores. Mortality is produced by the disruption of chemical bonds within the cell membrane.[10] PAA-based sanitizers are frequently paired with stabilized hydrogen peroxide. These sanitizers function well under cold conditions (~ 4 °C), thus producing acceptable microbial mortality on equipment normally held below ambient temperature. PAA is also effective in removing biofilms and is more active than hypochlorites.[11]

PAA solutions can be attenuated by the organic load and will begin to lose activity as the pH approaches neutral. These solutions are applied at concentrations ranging from about 100 ppm to 200 ppm for peroxyacetic acid and 80 ppm to 600 ppm for hydrogen peroxide.

PAA-based sanitizers are environmentally friendly as the compounds therein break down into acetic acid, oxygen and water. These sanitizers are also less corrosive to equipment than hypochlorites. As with any highly active oxidizer, concentrated PAA can present a safety hazard.

Quaternary Ammonium Compounds (QACs or Quats)
Quaternary ammonium compounds are fairly complex chemicals in which nitrogen is bound to four organic groups. The positively charged cations in the compounds bind with the acidic phospholipids in the microbial cell wall.[12] This action blocks the uptake of nutrients into the microbial cell and prevents the discharge of waste. In general, QACs are effective against a wide range of microbes, although the spore phase is unaffected. At lower concentrations, Gram-positive bacteria are more sensitive to QACs than Gram-negative bacteria.10 QACs are formulated in many different variations for specific situations.

QACs may be applied at concentrations varying from about 100 ppm to 400 ppm. As sanitizers, QACs are commonly applied at 200 ppm to food contact surfaces, and the solution is allowed to dry. Once dry, a residue of the QAC compounds remains and provides germicidal activity until degradation occurs. QACs also can function as detergents when present in high concentration because the compounds possess both hydrophilic and lipophilic chemical groups.

QACs are usually odorless, nonstaining, noncorrosive and relatively nontoxic to users. They function well over a broad temperature range and a wide pH range, although activity is greater at warmer temperatures and in alkaline situations. While QACs tolerate light organic loads, heavy soil will decrease QAC activity significantly. Some QACs may not function adequately in hard water, but others are formulated with added chelating agents that allow such use.[11]

While QACs do combine with organic compounds and are discharged into the environment, the concentrations are low and heterotrophic bacteria are not negatively impacted.[13] Soil-inhabiting bacteria such as Pseudomonas spp. and Xanthomonas spp. can degrade QACs.[14] In addition, the low amounts of QACs flowing into commercial sewage treatment facilities appear to combine with the anionic surfactants present to form complexes that reduce or eliminate toxicity.[15]

Resistance to Sanitizers
Any time a chemical is used to produce microbial mortality, the possibility of promoting resistance exists. This is because not all of the microbes are killed. A 5-log reduction (99.999%) still means that of 1,000,000 microbes present, 10 have survived, even though the process has reduced the population to what can be termed a safe level. The sanitizer could have just missed these 10 organisms or they could inherently be immune. If these 10 microbes are indeed immune, over time they will proliferate, and the usual sanitizing concentration and/or chemical will no longer produce acceptable mortality. At this point, measures must be taken to disinfect the surfaces in question. It then becomes imperative to know what organisms are specifically present so that the proper disinfectant at the proper strength maintained for the required time can be applied.

Sometimes, it is thought that bacterial resistance is present when actually the organisms are avoiding contact with the sanitizing chemical because a biofilm is present. Biofilms are polysaccharides that allow attachment to most any surface. Bacteria such as Escherichia coli, Salmonella spp., Listeria spp., Campylobacter spp. and several others can produce biofilms. Over time, the film becomes enhanced and may contain different species of bacteria, yielding a constant source of contamination. Whether biofilms are truly products of bacterial resistance may be a philosophical question, but the presence of biofilms can be an indisputable problem for those assigned to find a solution.

Conclusions
As you probably have noted, no mention has been made of another chemical used extensively, namely, water. Various forms of water can sanitize, but, as stated initially, the focus of this discussion was on the more common chemicals traditionally used for sanitization.

Article taken from: Food Safety Magazine

By Donna F. Schaffner, M.Sc.

Sanitation and cleaning of a food processing facility should be a documented program, following a step-by-step process that has been validated to accomplish stated objectives, utilizing specified chemicals and tools. Sounds easy enough, right? But is it?

First, what are your “stated objectives”? Are you wiping the accumulated dust and debris off the top surface of overhead structures in a food processing area to maintain a sanitary environment as per Good Manufacturing Practices published in the Code of Federal Regulations? Or are you pumping a caustic chemical through the piping of your liquid product handling system to flush out product residue that might support the growth of pathogenic microorganisms? Are you hand-scrubbing pieces of equipment to remove visible soils prior to placing them in a wash basin with hot, circulating chemicals to eliminate any trace of an allergenic product before using that same equipment to process another product that does not contain the same allergenic ingredient? Each of the above scenarios would involve a different set of actions to accomplish and likely require different detergents/cleaning chemicals/solvents and different tools. When it comes to sanitation, one size does not fit all.

Putting Food Safety on the Line
Just as food can be manufactured in a methodical, linear fashion, so can food safety be achieved by following a sequential method—and attention to detail. If deciding your objective(s) for a specific cleaning task is the first step, next you should determine which steps would most effectively allow you to achieve your goals. A good starting point is to learn the steps for disassembling and cleaning the equipment in a processing room by working with your maintenance person both to review the operation manuals for each piece of equipment and to create a step-by-step cleaning program. Often, manufacturers’ machine manuals recommend the type of cleaning chemical that can (or cannot) be used on that equipment.

The next step in this process is to determine what chemicals will be used for cleaning the equipment (and surrounding areas). Your chemical sales representative should be a good resource for learning the manufacturer’s recommendations on use of each cleaning agent under consideration. Early in my career, I had the good fortune to work with an exceptional sales rep who recommended that I take a food plant sanitarian training course; afterwards, he worked with me to create the Sanitation Standard Operating Procedures (SSOPs) for the entire processing plant. I currently work with an excellent sales manager who is a great resource for keeping current on the newest cleaning products available, and the exact amounts and application rates for each of those chemicals we purchase. I can now write my own SSOPs without any problems.

Both of these individuals worked closely with me to train the sanitation crew to implement and follow the written procedures we created. For successful training, the sanitation crew members must be given a hands-on demonstration of the procedure, with ample time for questions and discussion, be tutored through the actions themselves while being observed and given additional instruction if needed, and then have close supervisor oversight and monitoring of actions until they understand and can follow the procedures they were trained to perform. Having learned from experience that not all chemical sales reps are created equal, I would recommend that if you do not find that yours is sufficiently knowledgeable or willing to assist you in this manner, you might want to try contacting someone at a higher level in that company. Hopefully, they do have this type of resource available to you, if you search for it.

What Is “Clean Enough?”
After working out the details of equipment parts removal and order of removal for cleaning your equipment and which chemicals to use and in what concentration, how do you know when the equipment or room is “clean enough?” Simply put, validation is the process of proving that your written SSOPs, when properly implemented, will actually do the job that was intended to produce the desired result. A good cleaning program removes all visible soils, food buildup and microbial cells. A test result of less than 10 aerobic plate count (APC) or total plate count (TPC) and “negative” for presence of pathogens is what you want to achieve.

For example, to validate the effectiveness of your drain-cleaning procedure, you would have your regular sanitation crew clean the drain using the steps and chemicals specified in the written procedure, and at the conclusion of a “normal” cleaning (before sanitizing), you would swab the drain with sterile microbiological swabs and test for APC or TPC or possibly other specific organisms. During the validation study, you should be taking multiple swabs from many different locations in the drain, especially in hard-to-reach areas such as under the lip or along any point where two surfaces meet to form a line or corner that might be more difficult to clean. Careful description of where each swab touched the drain is imperative to be able to correlate the results back to what part/area was tested at a later date. Taking photos of each swab location that includes a swab or swab container that is already numbered is one simple way to accomplish this.

Validation of a cleaning procedure and process might be something you can do in-house if you have knowledgeable people and a trained microbiologist on your staff, or else very experienced sanitation professionals. Otherwise, I strongly suggest you seek outside assistance with the validation process.

Here is a tip when creating a particular SSOP for the first time: A less-expensive and faster way to find spots that are difficult to clean and might be expected to give a less-than-good result from micro testing would be to use a luminometer and ATP swabs first. The next steps are to reclean and revise the procedure until you can get a zero count with the luminometer and are confident that the cleaning procedure is working as expected before going through the validation exercise with more expensive swabs that have to be sent to a micro lab for testing. Remember, always swab the cleaned area before applying final sanitizer, as the person taking the swabs has touched the area and might have contaminated it, and it will need to have a sanitizer applied before product is run on that equipment. Another reason to wait until after the swabs are taken before applying sanitizer is that some sanitizers cross-react with some of the reagents on certain swabs to give a false-high reading.

If you are validating a cleaning procedure or sanitation program for removal of pathogens and test the cleaned surfaces of food-contact areas for pathogens (such as Salmonella, Escherichia coli 0157:H7 or Listeria monocytogenes), make sure that all food products made on that surface prior to this cleaning are still in your control and on hold status until the testing results are returned to you as negative for all tested pathogens, or else you might find yourself in a recall situation.

What If It Was Not “Clean Enough?”
What happens when the micro lab results come back with higher numbers than you expected or wanted? In this case, your drain was not “clean enough.” There are a number of possible reasons for this:

The first person to question is the one who took the swab samples that returned a bad test result. Is that person properly trained in microbial sample collection technique? Or did she or he perhaps contaminate the swab during the sample collection process? During discussions with quality assurance technicians who swabbed an area that returned a high result, I have occasionally come across some very interesting techniques from people who turned out to have no background or training in aseptic technique. I have compiled a list of things not to do while collecting samples:

•    You should NOT hold the swab in your mouth to free up both hands for removing the drain cover.

•    You DO need to re-cover the swab and protect it from touching other things, even after you used it to swab an area.

•    You should NOT lay the swab on the floor after you sample the area so that you can use both hands to put the cover back onto the drain.

•    It DOES matter if you cough or sneeze onto the swab after you have removed the protective cover, even if by accident.

•    Dropping the swab into a puddle of dirty water on your way back to the lab DOES matter, and it should not be used even if it’s the only one you brought.

The next place you might want to look would be at the personnel doing the cleaning of the area that returned a bad result. You would want to review the written SSOPs with the individual to learn if that person understands what was expected and to ask if she or he might have “improved” on the procedure by leaving out some steps or doing it faster than normal, etc. A common problem I find is that many of the people doing sanitation work do not read or understand English, or else have a deficiency of understanding written instructions, regardless of the language. In this case, more hands-on training is required for that individual; my preference is to photograph every step of the procedure alongside the written SSOPs. Another very effective tool for this training is to show new employees a videotape of the procedure being properly performed.

If your discussion with sanitation and sample-taking personnel has led you to believe that the person performed the procedure and the swab collection and testing were done correctly, then another place to look is at your cleaning chemicals. Are they being used in the proper concentration per manufacturer’s instructions? I have found a situation where the concentration of chemical in the bottle being used was not the same concentration for which the cleaning procedure was written, and no one had noticed because the bottle looked almost exactly the same except for the concentration designation, such as 0.1 N vs. 1.0 N. Is it exactly the same chemical for which the SSOPs were written? Several times, I have found that a company used SSOPs written for one chemical, but later switched to a different chemical supplier and assumed that the new chemical was the same, when in reality, it was being delivered in a weaker concentration. The old SSOPs then no longer applied.

Your cleaning tools and equipment are also places to look. If the process involves a spray- or foam-on application, is the spray syphon system operating properly to pull in the correct amount or is the take-up hose clogged or leaking? Is the water-to-chemical-to-air ratio balanced correctly? Are the sanitation tools properly cleaned at the end of each cleaning shift or have they been left dirty to the point where they now cause contamination rather than remove it?

If all of the previous areas seem to be operating correctly, perhaps the bad micro testing results are because of a surface that is no longer cleanable. If your drain (or other tested area) is older, with scratches, dents and visible cracks or rusted and pitted areas, it may be impossible to clean using the method described in your SSOPs. Each imperfection in the surface to be cleaned, be it a crack or gouge or rubbed-rough area, allows food particles to collect where they cannot be reached by the normal cleaning process. This trapped food allows bacteria to multiply. The narrow inside bottom of the cracks can trap air, which prevents water or cleaning chemicals from actually contacting the bacteria beneath the air trap. It may be possible to clean such a worn or damaged area, but it will require more aggressive cleaning techniques and tools. Specialized cleaning operations such as dry-ice blasting or steam cleaning might get the area “clean enough” but now must be incorporated into your cleaning regime, and the SSOPs must be revised accordingly, for that particular area. More often, a damaged area that repeatedly fails cleaning verification tests will need to be repaired or replaced.

The surface to be cleaned might appear undamaged but fails the micro swab test because it has a biofilm buildup. The biofilm can sometimes be seen as a film that dulls the appearance of what began as a shiny surface, or may appear as a whitish or yellowish residue that can be scraped off the surface using a hard or sharp instrument. How to remove a biofilm depends on its substrate, which is another place where your chemical sales rep should be able to help you. A test kit can be used to determine what type of soil is present on your equipment by simply scraping a small amount of the residue and testing to see what type of chemical will dissolve it. For example, if you process dairy products or ingredients such as liquid egg, your equipment might acquire a white “milk stone” buildup that is formed primarily of calcium carbonate, needing to be acid-cleaned for removal. Other biofilms that form primarily from a burnt-on sugar- or starch-based material or a greasy/fatty/oily material will need a different type of treatment. Sometimes, the film isn’t removed without scrubbing or mechanically scouring the surface clean. Microorganisms protected by a biofilm can be exceptionally persistent and show up over and over again in your micro testing results, indicating that your equipment is not “clean enough.”

Another version of “clean enough” involves allergens. If you process food with one of the major allergens and then process another food on the same equipment that does not have that same allergen listed on the label, you run the risk of allergen material cross-contamination, which can lead to illness or even fatality in allergic individuals. You must validate that the cleaning procedure used between the different types of food can remove all traces of the allergen. An allergen validation is performed in a manner like that described above, but instead of sending the swabs to a micro lab to test for microorganisms, you test the swabs for the target allergen. A number of companies now sell swab kits for the major allergens. Some give a visible color-change reaction to indicate the presence of the allergen, whereas others must be sent for testing to confirm the presence (or absence) of the allergen. Many third-party audits require that an enzyme-linked immunosorbent assay-based test be used to confirm the absence of allergens.

Keep in mind that no matter how much money you paid a testing lab for your validation study results, that study and the results are valid only for the exact procedures and chemical cleaning agents specified in your SSOPs. If you change chemical suppliers, you must redo the validation study using your current chemicals. Some audit companies now request that you redo the validation study annually to ensure that the cleaning process still works. Over a year’s time, surfaces can become damaged or biofilms can accumulate or the surfaces can be etched by acid sanitizers, and the cleaning procedures may no longer be sufficient. Anything that removes the hard, shiny surface the equipment once had can cause it to become more and more difficult to bring back to a “clean enough” state.

Restoring “Clean Enough”
An alternative being used by many smaller companies is to hire a contract sanitation company to bring in a crew of professional sanitarians, rather than having operations employees do the cleaning. A good, competent sanitation professional does not just walk in off the street; this individual must be sufficiently strong enough to pull around heavy hoses and sanitation equipment, able to lift and move heavy machine parts, have the stamina to physically scrub food residue off equipment and lungs robust enough to work in a hot, steamy environment that sometimes involves strong chemical fumes and the endurance to do all of this wearing heavy boots and protective clothing. To be good at his job, this person also needs to have meticulous attention to detail and be self-motivated to inspect his work and reclean an area that isn’t right the first time. He must also be willing to work third shift and/or weekends. The sanitation employee described above only becomes competent with experience; after getting experience and being good at their job, these people are not minimum-wage employees. That is a major reason why many smaller food processing companies are looking to contract cleaning as a resource, because they do not feel that they can afford to pay the wages needed for retaining an entire crew of good sanitarians full time. Others have been able to cut costs based on longer production runs that require the system to be completely cleaned only at periodic intervals, thus allowing the use of a contract cleaning service rather than full-time sanitation employees. Some have done the micro testing and used a history of no problems to justify the risk of running longer production lots with only minimal cleaning during the week, and then having a complete breakdown and cleaning of equipment only on the weekends.

Keep in mind that the company making the food is still the one responsible for ensuring that the entire facility stays in a sanitary condition and that the facility and all the equipment are “clean enough” to produce safe food. “Trust but verify” and make sure you have the documentation to show that your equipment is indeed “clean enough.”

If It’s Not Enough
Ultimately, you define what is “clean enough,” sometimes with direction from regulatory officials or third-party auditors. Then it is the production facility management’s responsibility to ensure that all SSOPs are implemented and that the results are properly documented.

This system works well until something goes seriously wrong. Typically, a sanitation failure comes to light only when it has progressed to the point of grossly contaminating product. For example, one night of forgetting to remove the belt off a product-contact conveyor to clean the underside might not cause a major problem by the time the system starts up again the next morning, but an employee deciding to bypass the SSOPs and failing to remove the belt night after night would allow residue to accumulate to the point where it contaminates most if not all of the product moving along the top side of the same belt. In this last example, a poor decision made by a sanitation employee of it’s “clean enough” after just spraying water on the top side of the belt, a supervisor who did not go out to inspect all of the equipment to see if things were cleaned properly and no quality assurance person checking to see if everything was really clean prior to start, over an extended time, led to the company having to recall product containing L. monocytogenes with an associated cost of millions of dollars and loss of an entire product line.

I cannot stress strongly enough that plant management must always be diligent in checking to see that all sanitation procedures are properly implemented all of the time. Unannounced inspections of equipment and facilities should be performed by more than one member of management, at irregular intervals and unexpected times, to ensure that the sanitation program stays compliant with those policies and procedures that were validated to get the facility “clean enough.” None of us wants to end up in court trying to explain why we did not use due diligence to make sure that our consumers never became ill with a foodborne illness!

Article taken from: Food Safety Magazine

By Margaret Hardin, Ph.D.

An effective sanitation program is key to controlling food safety issues such as Listeria monocytogenes and Salmonella and maintaining product shelf life. The type and frequency of cleaning depends on the complexity of the process, equipment design, and types of soils involved. This program includes both a regular cleaning program which is every 24 hours for most processes, and on a less frequent basis, specialized cleaning procedures, such as deep cleaning, are necessary for equipment and the environment. Deep cleaning is an intensified cleaning procedure that involves the extensive disassembly of all equipment to allow the cleaning of harborage and niche areas and components of equipment, getting deep into cracks, crevices and pores that are difficult to reach during the normal, daily sanitation process. These are the areas where food residues and fines from foods, liquids from marinades, pin feathers and fish scales can become trapped inside equipment and the only way to clean is to access their hiding places. A thorough breakdown of equipment can be time consuming and labor intensive and requires the coordinated efforts of production, maintenance, engineering, sanitation, quality and food safety. Some outside expertise such as a sanitation specialist, refrigeration, and your chemical representative may also be of value. Due to the extensive nature of the breakdown, deep cleaning often occurs when there is a holiday or a planned production down day. All conveyors, belts, rollers, sprockets, shaft drives, turn drives, cogs, wear strips, guides, tables, sorters, packaging machines, scarpers on the ends of belts and entrances and exits to cookers and freezers must be broken down to the frame paying particular attention to where niche areas may be in and around equipment. This includes all equipment such as freezers, fryers, cookers, steamers, battering equipment, slicers, dicers, chillers and packaging equipment as well as any part that can be removed including gaskets, guards, o-rings, seals, slicer blades, grinding plates, blades, auger, doors, blender blade and shaft. The breakdown also includes items such as chain guards, electrical panels, control panels, motor covers, floor scales, doors and overheads such as cooling units, drip pans, exhaust ducts, fans, lights, ceilings and walls that are sometimes overlooked during normal sanitation. Be sure to review the proper breakdown of refrigeration units with engineering or with a refrigeration specialist before proceeding. Remember to cover water-sensitive equipment and electrical components before rinsing. However, these sensitive areas must also be cleaned using the appropriate chemicals.

The breakdown process may lead to a breakdown of unexplored areas of equipment so having maintenance on hand to assist in the breakdown is invaluable. The process can also lead to opportunities to redesign parts to be more easily removed and cleaned in the future. Be sure to keep track of parts such as screws, bolts, hoses, wear strips and guides for equipment such as conveyors. These parts can be placed in tubs and labeled with the equipment or conveyor number on it to keep track of conveyor belts and associated guides, parts and pieces. A map of the room and lines with a number or color code can also assist in keeping track of parts and pieces. Following removal, conveyor belts can be put into vats for scrubbing or laid out on plastic sheeting covering the floor to access all areas for scrubbing and cleaning as long as attention is paid to controlling cross contamination from the floor and equipment to the belting during the cleaning and sanitation process. Following the equipment breakdown, equipment surfaces, framework, and the environment (non-food contact surfaces) must be cleaned thoroughly, including adequate dry pick up, rinsing of equipment, correct chemical concentration and complete coverage and scrubbing of all equipment surfaces. Scrubbing is necessary to remove residues and biofilm build up that are not visible to the human eye and are too often neglected due to the time-consuming and labor-intensive nature of the task. Too often sanitation crews chase food particles across the floor with a hose or spray equipment that is already visibly clean instead of using valuable time applying the mechanical action so critical to the cleaning process. Nonfood contact areas, such as walls, floors, undersides of equipment and tables and equipment frames, must be scrubbed as well as food contact surfaces as these surfaces are just as important as product contact surfaces. In order to achieve this, the same emphasis on cleaning and sanitation must be placed on these too often neglected surfaces as it is on product contact surfaces.

Following application of cleaner, scrubbing and rinsing, a sanitizer is applied to equipment surfaces. Following cleaning and scrubbing, some items such as belts and floor mats may also be soaked overnight in sanitizer. During the assembly of equipment, caution must be taken to avoid recontamination of equipment by employees, tools, lifts and ladders. When all the equipment is up and running, a final sanitizer is applied and the equipment and intensive breakdown can be added to a master sanitation schedule. If a facility has had problems in their ready-to-eat or even in raw areas, supplementing the cleaning process with an additional cleaning step that includes a strong oxidizer such as a hydrogen peroxide-based cleaning chemical can help to reduce microbiological issues related to food safety and shelf life. Incorporating a specialized cleaning process, such as deep cleaning, into a sanitation program will improve your overall sanitation program, and go a long way in protecting your brand, and ensuring product quality and food safety.

Article taken from: Food Safety Magazine