The health and well being of millions depends on manufacturers’ and packagers’ ability to maintain a safe and sterile environment during production. This is why professionals in this sector are held to much stricter standards than other industries. With such high expectations from consumers and regulatory bodies, a growing number of food companies are opting the use cleanrooms.
Cleanrooms are sealed off from the rest of a laboratory or production facility. Through stringent ventilation and filtering systems, they protect against contaminants that might be found in an unrestricted environment. Mold, mildew, dust and bacteria are sifted from the air before they can enter the space.
Personnel who work in a cleanroom are required to adhere to rigorous precautions, including clean suits and masks. These rooms also closely monitor temperature and humidity to ensure the optimal climate.
Cleanrooms can be found in numerous applications throughout the food industry. Specifically, they are used in meat and dairy facilities, as well as in the processing of foods that need to be gluten and lactose free. By creating the cleanest possible environment for production, companies can offer their customers peace of mind. Not only can they keep their products free from contamination, but they can extend shelf life and increase efficiency.
If you want to learn more about cleanrooms and their classifications, take a look at the accompanying infographic. It details the essential requirements and standards for facilities in the food industry and beyond.
By Cori Goldberg, Adam Brownrout, John Kendzior No Comments
On October 29, 2019, the USDA released its long-awaited draft rule establishing a domestic hemp production plan, providing clarity to growers and ancillary businesses about how the USDA will regulate the hemp crop. The USDA, under authority provided by the 2018 Agricultural Improvement Act (2018 Farm Bill), was tasked with promulgating regulations and guidelines to establish and administer a program for the production of hemp in the United States. This rule has now arrived and been published in the Federal Register. The rule provides requirements for all state and tribal hemp production plans including requirements for testing hemp, licensing growers, disposing of non-compliant hemp, and collecting and storing information related to hemp production. The USDA will now accept public comment on the rule until December 30, 2019.
Although the USDA rule will greatly contribute to the expansion of legally grown hemp in the United States, this rule does not alter the law regarding CBD foods and CBD dietary supplement products. This is because the 2018 Farm Bill left intact FDA’s authority to regulate the sale and marketing of CBD foods, dietary supplements, drugs, and cosmetics, as those product types fall under FDA’s purview generally. FDA has allowed the sale of CBD cosmetics, with certain restrictions, and companies may submit CBD products to FDA through FDA’s drug approval process. However, it has maintained that the addition of CBD to foods and dietary supplements is illegal. Under the federal Food, Drug, and Cosmetic Act (FDCA), once a substance is approved as an Active Pharmaceutical Ingredient (API) in an FDA-approved drug, that substance may not be placed into interstate commerce in a food. Also under the FDCA, once a substance is approved as an API in an FDA-approved drug, that substance is excluded from the definition of a dietary supplement. FDA approved the pediatric epilepsy drug, Epidiolex, whose API is CBD. Therefore, FDA has concluded that CBD may not be placed into foods in interstate commerce and that CBD products are excluded from the dietary supplement definition and therefore may not be sold as dietary supplements. The USDA rule does nothing to change the legal status of CBD food or dietary supplement products. Thus, despite the expected increase of hemp availability following the passage of the USDA rule, CBD companies must wait for the FDA green-light in order to manufacture or sell hemp-derived CBD food products lawfully.Learn more about important regulatory & quality issues in the cannabis space from Cannabis Industry Journal
So what does the USDA rule do? Under the USDA rule, states and tribes will have the option of either submitting a proposed hemp regulation plan to the USDA for approval or agreeing to submit to the USDA’s general requirements. All state and tribal plans must include certain provisions, including but not limited to:
Land used for production: State and tribal plans must identify a process for collecting, storing and maintaining relevant information regarding land used for growing hemp in the state. This includes information regarding the description, acreage, and boundaries of the farm land.
Sampling and testing for delta-9 tetrahydrocannabinol (THC): State and tribal plans must implement testing procedures to ensure that plants do not exceed THC levels above 0.3% (as provided in the 2018 Farm Bill). All testing facilities must be DEA approved, as non-compliant product with THC levels over 0.3% would be considered “marihuana” and a schedule 1 substance under the Controlled Substances Act of 1970 (CSA). Additionally, laboratories will be required to report a “measure of uncertainty” in their testing, designed to provide a buffer for the potential variation in sampling and testing procedures. Accordingly, plants testing higher than 0.3% THC but still within the “measure of uncertainty” will be considered compliant.
Disposal of non-compliant products: States and tribes must develop a procedure for destroying non-compliant cannabis containing more than 0.3% THC. Because non-compliant product is considered a controlled substance, all product must be disposed of in a manner consistent with the CSA. Therefore, product must be collected and destroyed by a DEA agent or law enforcement officer.
Inspection of hemp producers: States and tribes must develop procedures for inspecting hemp producers on an annual basis and also for inspecting random samples. The state must also develop procedures to identify and attempt to correct certain negligent acts such as not obtaining licenses or producers exceeding acceptable hemp THC levels.
Information sharing: State and tribal plans must include procedures for reporting information to the USDA. This information must be provided to the USDA within 30 days of receipt from the hemp producers and includes contact information for all hemp producers in the state, legal descriptions of the land used for hemp production, and the license status of all hemp producers in the state.
In states and tribes without an approved or proposed plan, hemp producers will be subject to the USDA general plan. The general plan also provides similar requirements for the testing and sampling of hemp. The USDA will provide licenses directly to hemp producers in states without an approved or submitted plan as some states may not want to have primary regulatory authority of hemp. These states will essentially hand over regulatory responsibility to the USDA. These licenses will be available by application 30 days after the final rule is published. Notably, the draft USDA rule also provides that states and tribes are restricted from prohibiting the transportation or shipment of hemp or hemp products produced under a state plan, tribal plan or a license issued under the FDA. The interstate commerce provision should put an end to the arrests of those transporting legally produced hemp from one state to another. For example, in July 2019, a trucker was arrested and charged with felony possessions of marijuana and intent to distribute while transporting legally grown hemp through South Dakota (South Dakota still considers hemp a controlled substance).
So while the USDA rule is much anticipated and grabbed the attention of many when published, food and dietary supplement manufacturers, distributors, and retailers are still stuck where they were before. We will all continue to wait and see what FDA will do.
Food and beverage professionals will agree that food manufacturing is a sector with conditions like no other. The industry is highly regulated because its products are for human consumption. Any deviation from strict control can lead to contaminated products with the possibility of outbreaks, illnesses and lawsuits.
Thus, maintenance managers in food manufacturing must contend with several unique challenges that come with multiple regulatory bodies, keeping highly automated and complex equipment running, and ensuring workers’ safety, all while producing hygienic goods.
This article will review three of the most common maintenance challenges being experienced in the food and beverage industry and some recommendations on how to deal with them.
1. Maintaining Complex Equipment
A typical food and drink processing plant today would be fitted with an array of complicated and highly sensitive equipment. From peeling machines to refrigeration plants and very complex packing machinery, every component demands constant attention.
Each one of these assets is part of a fast-moving production line that require specialized skills to monitor and keep in peak operating condition. In addition, this industry is under constant pressure to both improve and modify existing machinery, while also adopting new technology (especially automation).
Many food processors need to run their production 24/7 to stay competitive. It is apparent that the maintenance team has a lot to handle under such conditions,
To maintain the highly automated systems and keep equipment running optimally, food production and maintenance managers must stay on top of new techniques. They need to research, provide ideas and adopt newer and better maintenance strategies. Although it’s expected that there would already be some maintenance schedule in place, just any old routine will not work.
Imagine trying to run such a sensitive system on reactive maintenance alone where components are left to fail before repairs are carried out. Downtime would be disproportionately high and the enterprise runs the risk of shortening the lifespan of their assets. Instead, it is advisable to switch from reactive to preventive maintenance or look to implement any of the other proactive maintenance strategies like predictive maintenance or reliability-centered maintenance.
A proactive maintenance strategy is the most straightforward way to improve overall maintenance operations that will keep downtime and the associated stress of loss of revenue to the minimum.
2. Extremely Hygienic Workplace
Because they make products for human consumption, food and beverage manufacturers must enforce hygienic practices and maintain their equipment under the highest standards of food safety.
Failure to do this can lead to many serious problems like producing contaminated food, product recalls, foreign material complaints, lawsuits, outbreaks and infections (botulism, E. coli, Listeria, etc.).
To avoid the above, food and beverage manufacturers should pay attention to the following:
Pest control. Adopt pest detection, monitoring and control with or without the use of chemicals. Where chemicals are used, there should be extra care to avoid food and drink contamination.
Cleaning. Constant cleaning and disinfection is necessary to maintain high hygiene standards and reduce any risks of foreign materials complaints and foodborne illnesses outbreak. Cleaning also helps prevent injuries to workers particularly in the processing and packing areas where the risk of slips, trips and falls increases due to wet floors. Wet floors alone account for the second highest cause of injuries in the food industry, according to Health and Safety Executive.
Personal hygiene. Establish written and strict protocols for personal cleanliness of staff that include the use of Personal Protective Equipment (PPE).
Waste management. Prompt removal of waste materials to control odor and deter pests and rodents.
Overall maintenance. Adopt proactive maintenance schedules for the entire plant and all food processing machinery.
Staff training. Employees should be educated and trained for their own safety and to preserve the integrity of the plant and its products. This is vital for success because procedures will only be as good as the team that will implement them.
3. Compliance With Regulatory Standard
Manufacturers of edible products are subject to the regulations imposed by the relevant authorities in every country in which they operate. This means food and beverage manufacturers must:
Deal with a wide range of regulations regarding food safety.
Ensure strict enforcement with policies and procedures that could vary from country to country.
For example, manufacturers in the United States are subject to USDA Food Safety and Inspection Service (FSIS) regulations and those of the FDA. Food and drink processors in the UK are regulated by the Food Standards Agency.
Officials from these agencies are authorized to carry out unannounced routine inspections or complaints-based inspections. There are some critical food safety non-compliance issues they typically look out for. Maintenance managers must be aware of them and they include:
General cleaning. To minimize the risk of food contamination.
Machine safety. Machinery must be safe to use, all electrical faults should be corrected quickly, and any safety guards must be in place. Safety breaches in this regard can lead to serious injuries. An example is this 2014 case involving food giant Henz and a maintenance engineer where the employee lost an arm in an unguarded potato peeling machine.
● Food Safety. Machinery must run efficiently, be clean, keep food and drinks at the right temperature, be free of rust, etc.
● Pest Control.
To thrive in this industry, organizations need to be fully aware of the regulations appropriate to their kind of business and the risks under which they operate. The risk of contamination is ever-present but unfortunately, the nature of the business means this risk can not be completely eliminated.
One route for managing these challenges is a proactive and well-implemented preventive maintenance strategy supported by a computerized maintenance management system (CMMS) and properly trained staff. CMMS is designed to help you schedule, monitor, and automate your proactive maintenance work which enables you to stay in complete control of your maintenance operations at all times.
Such a well-maintained plant will be cleaner, last longer, run smoothly and generally perform more efficiently.
As much as food manufacturers take precautions to avoid all types of contaminants, there can still come a moment when you realize that your best efforts have failed. Maybe you find a broken blade or a missing wire during a sanitation break, but the product has already gone through your inline inspection machines—and nothing was detected.
This is the freak-out moment that no plant manager or quality assurance manager wants to have. Knowing that there’s possible contamination of your food product (and not knowing where that contaminant might be) creates a hailstorm of possibilities that your plant works hard to avoid. And you’re probably wondering how this could have happened in the first place.
Understanding How Contaminants Get Past Detection
To prevent physical contamination from occurring, it’s important to understand the reasons why it happens. In-house inspection systems often fail to detect contaminants for the following reasons:
The equipment isn’t calibrated to detect contaminants to a small enough degree, or the contaminants are materials that aren’t easily detected by the in-house machinery (glass, rubber, plastic, etc.)
The machines aren’t constantly monitored
The speed of the production line doesn’t allow for detecting small particles
Metal detectors are the most commonly used inline inspection devices in food manufacturing, and they depend on an interference in the signal to indicate there is metal contamination in the product.
Despite the fact that technology has progressed to deliver fewer false positives, the machines can still be deceived by moisture, high salt contents and dense products that could provide interference in the signal. When that continues to occur, it’s common for manufacturers to recalibrate the machine to get fewer false positives—but that also decreases its effectiveness.
Another limitation of the metal detector is that, as the name indicates, it can only find metal. That means contaminants like plastic, glass, rubber and bone won’t be found through a metal detector, but will hopefully be discovered through some other means before the product is shipped out.
Oftentimes, contamination or suspected physical contamination is discovered when a product, such as cheese or yogurt, goes through a filtration system, or when a piece of machinery is inspected during a sanitation break.
If the machinery is found to be missing a part, such as a bolt or a rubber gasket, the manufacturer then has to backtrack to the machinery’s last inspection and determine how much, if any, of the product manufactured during that time has been contaminated.
What To Do When Contamination Occurs
Once a food manufacturer discovers that it may have a physical contamination problem, it must make a decision on how to handle the situation. Options come down to four basic choices, each of which comes with its own risks and benefits.
Option 1: Dispose of the full production run
The one advantage of disposing of a full production run is that it entirely eliminates the possibility of the contaminated product reaching consumers.
However, this is an expensive solution, as the manufacturer has to pay for the cost of disposal in a certified landfill and absorbs the cost of packaging, labor and ingredients. It also presents the risk of lost revenue by having a product temporarily out of stock.
Option 2: Shut down your production lines for re-inspection/re-work
Running the product through inline inspections a second time may result in finding the physical contaminant, but there’s also a risk that the contaminant won’t be found—and now the company has lost money through overtime pay and lost productivity.
If the inspection equipment was not sensitive enough to find the contaminant the first time around, it may not find it the second time, which puts the manufacturer back at square one. The advantage to this method is that the manufacturer maintains complete accountability and control over the process, although it may not yield the desired results.
Option 3: Risk it and ship the product to retailers
There’s always a chance that a missing bolt didn’t make its way into the product. Sometimes, if a metal detector goes off and the manufacturer can’t find any contaminants upon closer examination, they will choose to ship the product and take their chances.
The advantage for them is that, on the front end, this is the least expensive option—or it could be the costliest choice of all if a consumer finds a physical contaminant in their food. In fact, the average cost of a food recall is estimated at $10 million; lawsuits may push that cost even higher and result in a business being closed for good.
Option 4: Use third-party X-ray inspection
X-ray inspection is the most effective way to find physical contaminants. In addition to metal, X-ray systems can find glass, plastic, stone, bone, rubber/gasket material, product clumps, container defects, wood and missing components at 0.8 mm or smaller.
When a food manufacturer has a contamination issue, it can have the bracketed product inspected by a third-party X-ray inspection company and only dispose the affected food, allowing the rest of the product to be distributed. This option allows the manufacturer to maintain inventory and keep food deliveries on schedule while still eliminating the problem of contamination.
X-ray inspection can find what other forms of inspection cannot, because it’s based on the density of the product, as well as the density of the physical contaminant. When X-ray beams are directed through a food product, the rays lose some of their energy, but will lose even more energy in areas that have a physical contaminant. So when those images are interpreted on a monitor, the areas that have a physical contaminant in them will show up as a darker shade of gray.
This allows the workers monitoring machines to immediately identify any foreign particles that are in the food, regardless of the type of material.
Detection is Key to Avoiding Contamination Issues
Handling contamination properly is vital to every food manufacturing company. It affects the bottom line and the future of the company, and just one case of a physical contaminant reaching the consumer is enough to sideline food companies of any size. As X-ray technology continues to evolve, it remains an effective and efficient form of food inspection.
Educating plant managers and quality managers on what to do if inline inspection machines fail to detect contaminants should include information on how X-ray technology can be a food company’s first line of defense. While physical contaminants can’t always be avoided, they can be detected—and the future of your company may depend on it.
Keeping your food processing facility clean is actually even more important than the food itself. What steps can you take to help keep your food processing facility clean?
1. Cultivate a Clean Culture
Keeping your facility clean is more than just your job. It’s the job of everyone who walks through your doors, whether they work on the factory floor or in the offices. Your first step should be to cultivate a clean culture. Get everyone involved, from the newest hire all the way up to the CEO. Everyone should have their assigned job, but they should also feel comfortable speaking to their supervisors or upper management to report spills, possible contamination and other cleanliness problems.
When you have human employees involved in the production process, there is always a chance the product can become contaminated. Personal hygiene can help to reduce the chances of contamination by keeping your employees clean and safe as well.
Hand washing, for example, is a step that is often neglected but can mean the difference between a clean batch of food and a contaminated one. Good hand washing procedures can also help reduce the spread of cold and flu germs inside the workplace.
Personal protective equipment also falls into this category—gloves, hair and beard nets, shoe booties and other coverings should all be worn to lessen the possibility of contamination.
3. Keep Up With Your Equipment
The exact equipment you need to complete your work will vary depending on the type of food you’re processing, but for most foods that start with raw ingredients, you will need some sort of sifting equipment. These are designed to remove under- and oddly-sized food items or to remove dirt, leaves or other debris that might have come in contact with the food from the field where it was harvested.
Most sifting equipment relies on vibrating or moving sifters that can throw small particles into the air. While necessary, this also creates a new potential source of contamination for your food items. Investing in sifting equipment with a dust hood can help solve this problem. Not only do dust hoods keep your product and facility cleaner, machines with dust hoods reduce air pollution too.
4. Food Storage and Temperature
Food production facilities are at the mercy of temperature. Food that is allowed to get too warm can grow bacteria, making it dangerous to consume. Food that is left for extended periods of time at temperatures between 41 and 135 degrees Fahrenheit are also at risk for bacterial and microorganism growth.
Be vigilant about the temperature at which your food is stored. Food that needs to stay hot is required to be kept at 140 degrees or above, and cold food needs to be kept below 41 degrees.
5. Clean, Clean and Clean Again
Keeping all of your equipment clean and sanitized is an essential step in the maintenance of your food processing facility, but many pieces of equipment are not designed to be disassembled and sanitized separately. This may be tricky when there are cracks and crevices where food particles can get stuck, encouraging bacteria growth. You have two options for cleaning your equipment—clean in place and clean out of place.
Cleaning in place, as its name suggests, involves cleaning your equipment without taking it apart. This includes running sanitizing chemicals through the equipment and cleaning all accessible surfaces.
Cleaning out of place requires shutting down the equipment and disassembling it, allowing you to clean and sanitize all of those hard-to-reach corners. Depending on the piece of equipment, this may require shutting down your entire production line, so be sure that cleaning out of place won’t impact your production deadlines.
6. Cut the Clutter
Clutter in a workspace, even if it’s just boxes of product waiting to be palletized, can contribute to an unclean and unsafe work environment. Clutter allows the collection of dust, which can make its way into both food and equipment.
Take the time to dedicate specific areas to storage, preferably away from the primary production line. Keep your main traffic routes clear to prevent on-the-job accidents and ensure that anything kept in overhead storage is stable with no risk of falling.
7. Keep Covers and Guardrails In Place and Maintained
Open tanks or containers that process food are prone to contamination and are difficult to keep clean. Any tanks or containers that have covers on them should be covered at all times to ensure the product is kept clean.
For places where guardrails are necessary, such as above production lines or other elevated walkways, confirm that the rails provide coverage on all exposed sides. Make sure that there is also no risk of any dirt or other contaminants from shoes or the walkways falling into food or onto the production line.
A dirty production line can cost you thousands of dollars to correct, costing even more if the contaminated product has to be discarded. Take the time to maintain your cleanliness and keep your facility running smoothly.
While building an effective logistics strategy, the end goal of supply chain management (SCM) needs to be kept in mind (i.e., allowing each member of the supply chain to achieve efficient inventory management as well as reach its customer service goals). To this end, it’s important to share information that will help each member achieve success. This includes data relating to demand forecasts, anticipated lead times and safety stock quantities. Let’s look at SCM best practices for food manufacturing and supply, and how this information plays a role.
Effective SCM: Best Practices for the Food Industry
Here’s an overview of SCM best practices in food supply and manufacturing:
Learn more about managing your supply chain at the Best Practices in Food Safety Supply Chain conference | June 5–6, 2017 | LEARN MOREDemand Forecasts. This is generally based on demand, sales or usage patterns in the past. However, future demand can be affected by changing situations such as:
Increased/decreased product popularity
Introduction of new products
Short-term increase in demand through promotions, etc.
Better estimates can be achieved with an effective derived demand or a CPFR (collaborative planning, forecasting and replenishment) system. This can be done through automated data collection, or by the following process:
Identifying customers who can predict future demand (i.e., what they may use or sell in the future)
Collecting demand forecasts about specific products from them
Comparing these forecasts against their actual purchases on a monthly basis
Helping them improve future predictions by sharing this data with them
Customers may overestimate demand, but you might consider offering a discount based on accurate forecasts to encourage better results. In addition, you should also consider these five elements:
Usage patterns in the past, not including CPFR data
Increasing/decreasing product popularity trends
Higher/lower seasonal usage or demand
Events/promotions in the near future
Market and industry data from sources such as management, sales, etc.
Part two of Food Safety Tech’s interview with Alan Baumfalk, lead auditor and technical manager for Eurofins food safety systems, discusses how companies can reduce their chances of having a food crisis. “Sometimes we forget that part of our crisis management team is part of food defense,” says Baumfalk.
Food Safety Tech: Can you discuss the importance of the food defense plan within crisis management?
Alan Baumfalk: We need to defend the product within our facility, and we need to determine as part of the food defense plan the methods that we’re going to implement to prevent adulteration of product.
We need to step up and watch this: The process literally travels from farm to fork; from the crop through processing through distribution and to the final consumer. As part of our food defense plan we need to protect sensitive processing points from intentional adulteration, and we must watch for potential accidental adulteration.
It is important to carefully control the activities in the plant. Part of that involves limiting employee, subcontractor and visitor access to production equipment, manufacturing, and storage areas by designating access points.
These steps can help to eliminate issues involved in causing a crisis:
Secure the storage of raw materials, packaging equipment and hazardous chemicals
Control all chemicals within the facility, because they can be used to deliberately or accidentally contaminate food.
Hold finished products in secure storage.
Control transportation. Apply seals to the full truckload.
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