Would you like to save up to $1.5 million each year?
According to statistics cited by Remco Products Education and Technical Support Manager Amit Kheradia, having the facility, equipment, tools, and utensils be of sanitary design can help companies save about $0.5-$1.5 million annually by greatly minimizing the chances of costly product rejects, recalls, and associated expenses.
WHAT CAN GET IN WILL GET OUT. A crack that is barely visible to humans is like the Grand Canyon to pathogens, said Mérieux NutriSciences Senior Director of Technical Services Steve Decker. So gaskets, poor welds, metal-to-metal and plastic-to-metal interfaces are all perfect hiding places for contamination. And, he said, “What can get in will get out.” Due to poor sanitation practices, these harborage areas can grow into growth niches where food, water, temperature, and time will allow a transient pathogen to become established.
The two primary pathogens that will likely take up residence in equipment, and the facility in general, are Salmonella and Listeria monocytogenes, Decker added. Salmonella is predominate in dry, warmer food manufacturing facilities, while Listeria is associated with wet, cool, and cold environments. However, they can be found in both.
Thus, Kheradia said, “Sanitarily designed equipment is vital for ensuring safe and quality food products because the equipment is more easily cleanable, more durable, and less likely to carry contaminants,” which helps prevent or significantly minimize microbiological, allergen, and foreign particle cross-contamination incidences in a facility. Bacterial pathogens need to be controlled as they can survive and grow in the nooks, crannies, and other relatively inaccessible surfaces of equipment. Then, he said, “Contaminants may be transferred from the equipment surface to food through the environment, operating personnel, or even operational utilities like water, steam, or drains.”
Prerequisite and GMP programs — such as personnel hygiene practices, risk-based facility zoning, and structural and grounds maintenance — will complement the equipment design, installation, and operational procedures, Kheradia said.
Additionally, a well-developed and effectively implemented preventive maintenance program for the facility and equipment can assist in ensuring the sanitary integrity of the production processes. Any broken or non-functional equipment must be properly repaired or replaced to ensure sanitary operations in the plant.
MICRO-CRIME SCENE INVESTIGATION. To determine if equipment is causing a food safety issue, in-line processing samples can be taken at various points throughout the process and after any lethal step — with a test-and-hold program if production is occurring.
Another option is have the equipment extensively swabbed by a trained person, e.g., a micro-crime scene investigator (MCSI), Decker said. Places that the investigator cannot see but the product touches are red flags of potential harborage areas, especially if this area is not torn down during routine sanitation. “Allowing the equipment to run for several hours without product, then swabbing it will let the microorganisms be pushed out of their hiding places and get detected by the swabbing,” he said.
In the purchase of new equipment, he added, “Hygienic design should be, if not first in the decision making, at least in the top three criteria when evaluating new equipment.” The ability to easily break down the equipment so the operators and sanitation crews can properly inspect and clean, is crucial. “Often nuts, bolts, wrenches, and screwdrivers are needed for sanitation purposes if equipment is not easy to disassemble –— and it’s often not,” he said.
“Purchasing used equipment can be a risk,” Decker added. If the equipment was not maintained in a hygienic manner, the Trojan Horse syndrome may apply, as pathogens may be hiding inside to be carried in to your facility. To verify an equipment’s hygienic condition, he said, extensive swabbing and disassembly should be conducted before it is placed into production.
FOREIGN OBJECTS. It is the nuts and bolts of equipment that can be the basis of another potential equipment issue: foreign objects (metal, plastic, etc.) breaking or disconnecting from the equipment and falling into the food. This was, in fact, the basis of two observations in an FDA Warning Letter issued to the CEO of a baked-goods facility.
- The mesh-belt conveyor carrying bagels through the proofer was seen broken or missing pieces in several places. The shape and size of the missing pieces of mesh-belt conveyor material was consistent with reported customer complaints the firm received.
- Several metal spikes were seen broken and/or missing from the metal cylindrical aerator used to perforate the in-process dough. There was no metal detector or other protective measure in place to detect metal.
According to the Code of Federal Regulations (CFR) Title 21, “Effective measures shall be taken to protect against the inclusion of metal or other extraneous material in food.” While the CFR goes on to note that compliance may be accomplished by using sieves, traps, electric metal detectors, or other suitable means which detect and capture metal, it is even more advisable to prevent metal fragments in the first place.
According to an FDA report, one significant cause of this can be poorly maintained equipment and lines. Because pieces of equipment can break off and enter food products during processing if equipment is poorly maintained, routine or preventive maintenance, and other periodic checks of equipment, can minimize the risk from this safety issue.
Additionally an FDA guidance document written for fisheries, but applicable to all food processors, notes that metal-to-metal contact (e.g., mechanical cutting or blending operations and can openers) and equipment with metal parts that can break loose (e.g., moving wire mesh belts, screens, portion control equipment, metal ties, etc.) are likely sources of metal that may enter food during processing.
It is the nuts and bolts of equipment that can be the basis of another potential issue: foreign objects falling into food.
In that document, FDA advises that periodic examinations of processing equipment for damage that can contribute metal fragments to food product can help prevent the hazard of metal inclusion. A visual inspection, however, may only be feasible with relatively simple equipment, while more complex equipment that contains many parts, some of which may not be readily visible, may require controls such as metal detection or separation.
ROBUST PREVENTION. For prevention, the deep cleaning of equipment at a set frequency (monthly, quarterly, or bi-annually) must be built into the sanitation schedule, Decker said. A robust environmental monitoring program (EMP) also will greatly assist in preventing pathogens from migrating to and into your equipment and is a primary defense when maintaining your equipment in a safe condition. And, he added, “If the environment has been identified as a risk likely to occur, it must be built into your food safety plan.”
Apart from following good hygiene practices, prerequisites programs, and SSOPs, the facility and equipment should be of appropriate sanitary design, Kheradia said, noting the 10 principles of sanitary design recommended by the American Meat Institute (AMI):
- Cleanable to a microbiological level.
- Made of acceptable material.
- Accessible for inspection, maintenance, cleaning, and sanitizing.
- No product or fluid collection.
- Hollow areas of equipment are hermetically sealed.
- No niches or harborage points.
- Sanitary operational performance.
- Hygienically designed maintenance enclosures.
- Hygienic compatibility with other plant systems.
- Validated cleaning and sanitizing equipment.
CLEAN FIRST. SANITIZE SECOND. “It is essential to understand that cleaning refers to the removal of product and residual soil, and sanitizing is about the reduction of micro-organisms to a safe level, normally with the use of an approved sanitizer,” Kheradia said, adding, “The cleaning step is always done before sanitizing, and never the other way around.”
Following are five factors that need to be considered:
- Type of soil being cleaned: Is it organic, non-organic, sugary or fatty?
- Nature of soil: Is it loose or stuck-on the surface?
- Water quality and hardness: Is it potable and free from excess minerals that may affect sanitation?
- Wastewater treatment: How is this disposed of or treated so it doesn’t re-contaminate equipment?
- Corrosion resistance: Are the chemicals compatible with the surfaces being cleaned?
In conducting cleaning and sanitizing activities, there are many things to be considered, Decker said. Some critical factors are:
- The ability to disassemble the equipment easily.
- Proper selection, use, and monitoring of the sanitizer being used.
- Training the team being challenged to perform the tasks.
- Frequency of the sanitation and proper sequence of application of the rinse, detergent, and sanitizer.
- Using a flashlight during pre-sanitation and post-sanitation.
- Determining the chance for biofilm formation, and proper chemical selection to clean and remove it to ensure the sanitizer is effective.
- Having a seek and destroy mission in place, allowing for additional EMP samples to be taken during shutdowns and clean breaks.
- Knowing your equipment and which areas are difficult to clean so you can build it into the sanitation program.
Additionally, Decker said, “The use of high-pressure hoses will push food and pathogens deep into the equipment where they will become lodged and form a growth niche. Eliminating the use of these hoses, or at least educating the sanitation crew on the hazards (where and when they can be used), will be key in prevention.”
IS IT REALLY CLEAN? There are several ways to verify cleanliness, Decker said. The most widely used are visual, swabbing with a system to measure ATP, or swabbing with a sponge to determine microbial loads.
“The hardest areas to clean and sanitize should be the ones you are testing. Having someone other than the sanitation team perform the verification is highly recommended,” Decker said. Additionally, trending this data is always a good idea.
After completion of the sanitation process, the most common pre-operational inspection method is a detailed visual inspection, Kheradia agreed, adding, this is normally done by the operator or supervisor who can use mirrors, flashlights, cameras, etc. While microbial swabs can take several days to get the results, ATP bioluminescence swabs for organic residues can provide a rapid test of unclean spots. But, he cautioned, “Make sure to select a good sampling plan when taking swabs from equipment areas.”
Your equipment is the foundation of your facility’s food processing operations; but if it is not maintained in good, hygienic condition, it also can be the downfall of your business.
The author is Editor of QA magazine. She can be reached at firstname.lastname@example.org.