Food processors must balance many priorities. Unfortunately, those priorities often compete. For example, most processors put maximizing productivity and uptime at the top of the list. At the same time, operations like cleaning and sanitation require systems to be shut down.
Proper cleaning and sanitizing are vital for ensuring food safety and preventing recalls. However, the FDA’s inspectional observances for FY 2017 suggest that there’s room for improvement. Both Cleaning and Sanitizing Operations (failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination) and Sanitation Monitoring (failure to monitor sanitation conditions and practices with sufficient frequency to assure conformance with CGMPs) made the top 10 most-cited violations of last year.
To learn more about how processors can improve their approach to cleaning while still reaching their productivity and uptime goals, we spoke with Ole T. Madsen, president of process cleaning and sanitation equipment company McFlusion, as well as Liza Scurr, the company’s director of corporate development.
Madsen has been in the cleaning and sanitation business for a long time. With both a practical and educational background as a chemical process engineer, he has worked with a variety of process equipment in both pharmaceutical and food and beverage plants. In the 1990s, he started a company dedicated to cleaning and sanitation for the pharmaceutical industry. After selling that company to investors, Madsen started McFlusion in 2012.
McFlusion’s initial focus was also pharma, in particular, biotech and solid dose manufacturing, where cleaning is a very high priority because if the FDA finds something amiss, they’ll shut the plant down. In contrast, Madsen says that “in food and beverage, cleaning is the lowest of the lowest priority” — a necessary evil that gets in the way of manufacturing output.
“Processors tend to focus on sanitizing,” he says. “But they need to focus on cleaning because that’s what removes the material that causes bacterial growth. You can’t sanitize what isn’t clean.”
Of course, that’s a rule with many exceptions. Companies that have had problems in the past and those that want to protect themselves from problems in the future are more willing to invest in new cleaning equipment, and many sought out Madsen to help them up their game.
That’s how McFlusion entered the food and beverage industry. “It’s been a pull, not a push, process,” Scurr says. “Food companies started coming to us while we were busy on the pharmaceutical side. In fact we hesitated to go into food and beverage until we had the right product program and the ability to scale to meet the needs of such a diverse industry.”
The pieces all came together last year, when McFlusion launched a new website specifically for food and beverage and also attended PROCESS EXPO to start making connections. Today, McFlusion provides complete process and equipment solutions for cleaning, sanitization, and sterilization for the food and beverage industry. This includes clean-in-place (CIP), clean-out-of-place (COP), and sterilize-in-place (SIP) systems, as well as open plant equipment cleaning (OEC). The company’s customers range from small craft breweries to large frozen foods manufacturers.
A new approach to cleaning operations
Madsen’s goal has always been one of improvement. In his work with pharmaceutical companies, he developed cleaning technology that improves efficiency, reduces water and detergent usage, and boosts cleaning effectiveness to the highest degree. Crucially, they can also measure the results of the cleaning process in a way that’s not possible with traditional systems.
So, what does McFlusion do differently?
The common way of thinking about cleaning is based on the Sinner circle, aka the TACT principle, which establishes four factors that determine cleaning efficiency:
- Chemical (i.e., detergent)
If you increase or decrease one piece of the pie, you need a corresponding increase or decrease in another piece. For example, you can decrease cleaning time by increasing the amount of chemical detergent you use.
This is, in fact, the default setting for many food processors. “The typical approach is to start with detergent,” Madsen says. He notes that this because of how CIP is defined in the 3-A Sanitary Standards:
The removal of soil from product contact surfaces in their process position by circulating, spraying, or flowing chemical solutions and water rinses onto and over the surfaces to be cleaned.
This definition suggests that the only way you can clean is by using chemicals, Madsen says. As a result, when a company has a cleaning issue, the first thing they do is contact a chemical company.
The problem is that this solution doesn’t always work, especially for materials that aren’t water-soluble — like spray-dried products that are heated up and baked onto surfaces. The result is microbes that just won’t go away. For example, Madsen describes a case in which processors were sanitizing with chlorine. The initial ATP test looked fine, but 8 hours later, they had microbes again. This was because the cleaning process wasn’t sufficient to remove the residues that lead to microbial growth.
In addition to not being effective, using more or harsher chemicals isn’t particularly environmentally friendly. It’s also expensive.
McFlusion’s approach focuses on an underappreciated slice of the pie: action. Rather than increasing the chemical component, McFlusion’s CIP systems increase the action through higher pressure, higher velocity, and more turbulence, which creates more efficient impact. This approach enables processors to reduce the time devoted to cleaning by 40-75%, as well as water use up to 75% and detergent use up to 50%.
For those of you who might find these numbers unbelievable (Madsen admits that they look ridiculous on paper), the company is working with the engineering faculty at McMaster University in Ontario to perform third-party validation studies of the process.
Monitoring cleaning effectiveness
As the FDA inspection results show, cleaning and sanitizing is only half the battle — monitoring the conditions is the other half.
And McFlusion has a solution for that as well. The company’s other major innovation is a software that can precisely controlling all of the TACT parameters depending on the specific equipment and the type of product residues they need to remove, and also monitor the effectiveness of the cleaning program.
“The software tells the processor whether they’ve achieved the desired result in terms of pressure, flow, and energy input,” Madsen says. “If they don’t, it’s because there is something restricting flow through the pipeline, such as a blocked spray nozzle.”
The software can also detect if parts start leaking, which can happen, for example, in a complex system with many valves. “Sooner or later, something will start leaking,” Madsen says. “So, if you’re running a CIP cleaning cycle with alkaline in the line, it could be leaking into other parts of the process system. If you don’t detect and repair the leak, the alkaline can potentially get into the next batch of product.” He notes that this happens reasonably frequently for processors, whether they admit it or not.
Broader trends impacting cleaning and sanitation
Clearly, FSMA is a major driver of advances in thinking about cleaning and sanitation. But there are others as well, and they mirror broader trends in the industry as a whole.
First, CIP solutions like the ones McFlusion provides are automated, which contributes to their ability to decrease cleaning time. It’s estimated that 20% of every day in the life of a food and beverage plant is spent cleaning. That represents a lot of downtime that processors can potentially leverage. While U.S. processors have been somewhat slow to automate, Scurr points out that “Europe is moving forward with automation, and North America needs to keep up.”
Labor issues are another factor. Not only is the food industry facing a labor shortage and rising labor costs, but traditional manual cleaning processes can present safety challenges. “There are many examples of big companies who have hundreds of people coming in at night to clean the equipment,” Scurr says. “We’ve heard stories of accidents using power washers, that are serious problems in terms of safety.”
Finally, Scurr says that the recent spate of M&A activity, where big companies are scrambling to buy smaller ones, means that smaller processors now have more resources to draw on. This includes both money to invest in cleaning systems and insider knowledge of what happens when this investment is left too late. “It always costs more to fix something than to start out the right way,” Scurr says.
She adds that McFlusion offers a full product line, from open plant cleaning to the CIP systems with multiple components described above, so they can partner with companies from very small to very large, even if they aren’t ready to go all-in on automation. “We can also help companies structure and organize their manual cleaning to bring it to a higher level.”
Looking forward, Madsen and Scurr see all of these trends continuing to impact the industry, particularly automation, which Madsen believes will lead to “more controlled, quality-focused cleaning and sanitation.”
In addition, they expect new industry verticals and heightened consumer demands to push processors to reconsider how they clean.
On the vertical side, Scurr notes the relative newness of many industry sectors, like nutraceuticals, vitamin waters, and fresh cold-pressed drinks. “That whole industry didn’t exist 10 or 15 years ago,” she says. “The producers are very small and they have very short times to market. They will likely face the same problems that the bigger producers faced 30 or 40 years ago before they figure it out.”
Madsen also notes that consumers are developing more expectations about what they eat and drink in general. “We all want to live healthier,” he says. “And that’s leading to changes in how food is produced.”
Automation, workforce issues, consolidation, product innovation, consumer preferences — all of these themes have shown up multiple times in this interview series. The fact that they are also driving change in cleaning and sanitation is evidence that no area of food processing is immune to these forces.