Battling biofilm

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The best sanitation programs are designed along with the product and aggressively implemented early in the manufacturing process.

By Sarah Fister Gale

The cleaning, disinfecting, and sanitization of a clean manufacturing environment determine the safety and effectiveness of the end product. These steps make the difference between a pristine product and a sullied reputation, yet product designers across industries tend to spend little up-front time designing and prioritizing sanitation programs in the product development process–and that can lead to costly delays in getting products to market and surprising sanitation issues down the production line.

Every industry has different procedures to ensure the cleanliness of its products and the processing environment based on the risks to the end user. And while a manufacturer of raw food products that will be cooked by the consumer may have more contamination leeway than those making injectable pharmaceutical products or implantable medical devices, they all have the same agenda: to produce consumable products free from bacteria and other contaminants that could ultimately harm the user and the brand.

The most successful manufacturers see the sanitization program as an integral part of the product design process, says Lisa Foster, vice president of Steripro, the consulting and laboratory services division of Sterigenics International, a contract sterilization organization in Corona, CA. “People think cleaning, disinfecting, and sterilization are the last act so they can be left till the end, but that’s a huge mistake, whether you are in pharmaceuticals, medical devices, or food,” she says. “You need to look at these steps up front in the product design process long before you get to manufacturing.”

She advises clients to consider attributes of cleaning, disinfecting, and terminal sterilization during product design and assess those goals against all materials, ingredients, and process steps in the product. She points out that it’s easy to select materials that won’t be compatible with your sanitization or sterilization choices–Teflon, for example, can’t be gamma sterilized. “If you want a Teflon stopper or a pre-filled syringe, the product can’t be closed prior to sterilization.”

If a material you want or need conflicts with your sanitization goals, you can make decisions during the design phase to address the problem before the manufacturing environment is established. In the case of the Teflon stopper, you could opt to pre-sterilize the components separately using an aseptic filling step followed by terminal sterilization of the outside barrier, or choose another material for your stopper.

“You need to determine what methods will work and design the product around that,” Foster says. “When you develop a product with effective sterilization processes from the beginning, you will save a lot of time and money during production phases.”

A clean education

Once a product is designed and the sanitization program is established, the only way to ensure it remains effective is through training. “Good sanitization is all about education, and reminding people of the little things that they may know to do but can forget when they are under pressure to get the job done,” says Chris Celusta, manager of food processing sanitization for Spartan Chemical, a Maumee, OH-based manufacturer of chemical specialty maintenance products and industrial degreasers. “But don’t inflict paralysis by analysis. Sanitation crew training has got to be simple, to the point, and ongoing.”

Figure 1. Gamma sterilization is one method for sanitization of materials. Shown: A radiation source glows blue underwater, where it is kept when not in use. Photo courtesy of Steripro/Sterigenics.
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Celusta points out that while senior management may be committed to a clean environment, sanitation crews are often less tied into the corporate goals and strategies. They often work in low-level positions with high turnover, despite the fact that they serve a critical role in the production process. To ensure they are as committed to sanitization goals as the rest of the team, sanitation training must also incorporate the reasons behind the cleaning program. “You can’t just tell your cleaning crew what to do; you have to explain why they are doing each step and what the result will be if they skimp on or skip something,” Celusta says. “Otherwise, crews may make assumptions that can result in problems.”

Those problems are not just issues of yield or delays. When sanitation crews skip steps dangerous bacteria, including E. coli and Listeria, can gain a foothold in processing facilities and lead to outbreaks of foodborne illnesses. Each year an estimated 76 million people contract a foodborne illness and 5,000 die because of food safety issues from bacteria that can be prevented with proper sanitation.

Figure 2. The Cobalt 60 radioisotope is used for gamma sterilization in the underwater chamber. Photo courtesy of Steripro/Sterigenics.
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Those outbreaks don’t just hurt one company or brand. Every time the public learns of a food recall it loses faith in the entire food production industry, says Celusta, who notes that consumer confidence in food safety is at an all-time low. “When you have a national recall, it draws a lot of attention to sanitation strategies throughout the food industry,” he says. “Company owners and consumers want to know you are doing what you are supposed to be doing, and that every ingredient in a product comes from a reputable source.”

Ready-to-eat products, such as lunch meat or fresh-cut produce, pose the greatest risks because they don’t involve a cooking, cleaning, or other “kill step” by the consumer. Whatever goes out the door on the product will be ingested.



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