FDA IAQ Compliance Requirements In Food Production

During the fall of 2015, the U.S. Food and Drug Administration finalized a rule regarding preventive controls of human food. The final rule is part of the legal obligation of the FDA to provide guidelines that align with the Food Safety Modernization Act, a law signed into legislation in early 2011.

According to the FDA, the law is one of the most comprehensive reforms of food safety laws in the last 70 years. Prior to the signing of FSMA, laws were designed to respond to food contamination outbreaks. That has now changed, as the focus shifts more to preventing contamination.

Statistics from 2014 collected by the U.S. Centers for Disease Control and Prevention stated that throughout that year, 846 foodborne illnesses were reported, with 13,246 individuals falling ill and 21 fatalities. To help prevent these outbreaks, the FDA’s rule establishes regulations for manufacturers and compliance requirements to ensure food doesn’t become contaminated during the production process. These regulations specifically outline sanitary guidelines, which include air filtration systems.

Food production line.

What is the rule?

Preventive controls of the finalized rule indicate that within a food-processing plant, systems are required to ensure hazards are eliminated or minimized. The FDA stated that this requirement covers food allergens and sanitation controls.

While food manufacturing plants are likely outfitted with air filtration systems, the FDA has imposed compliance deadlines to ensure all aspects of food processing follow the rule and have the proper air filtration systems in place. Small businesses will have two years to comply, very small organizations, defined as, defined as those with less than $1 million in annual revenue, will have three years and every other company must comply in a year of the final rule’s publication.

Role of Air Filters in Food Production

Air filters, specifically HEPA filters, clean out the air when various foods are manufactured. It’s a process a majority of consumers likely don’t think about as they sit down to eat at the dinner table, but it’s one that has a huge effect on the final product.

For example, the process of making yogurt involves the filtration of plant air, according to Michael Bryne, a business and technical manager at EHL Group, a company that specializes in various engineering fields. He stated in a LinkedIn post that yogurt facilities need point-of-use air that is filtered to a sterile level, otherwise the final product may not turn out as intended.

Food processing plant managers and executives will have to ensure their facilities are outfitted with air filtration systems to minimize the risk of food being exposed to contaminants. Since companies will have time to comply with the FDA’s final rule regarding preventive controls for human food, they can contact Air Impurities Removal Systems to find the best filters available to use during the food production process.

HEPA vs. ULPA Filtration: What’s the Difference?

HEPA versus ULPA Filtration: What’s the Difference? 1

It’s difficult to imagine a time when clean air was the exception rather than the standard in places such as factories, hospitals, distilleries, and doctors’ offices. But before commercial air filtration was invented, workers were exposed to all manner of indoor air pollution (IAP). As a result, illnesses such as asthma, blood poisoning, even cancer, were not uncommon occupational hazards. The need for worker protection was great.

It wasn’t until 1942 that the first step toward safeguarding indoor air quality (IAQ) was taken. During WWII, a small band of research and development scientists working on a top-secret nuclear program were tasked with finding a way to control the spread of minuscule particles of radioactive matter in order to protect their fellow government workers. Due to their efforts on that classified post, code-named “The Manhattan Project,” the atomic bomb was developed. So, too, was the first HEPA filter.

But that one effort wasn’t the end of development of air filtration products to improve IAQ for workers.

In any industrial setting, there are multiple sources of IAP, most of which are a complex mix of substances which can vary in their potential health risks. Pollutants can originate from both biological and non-biological sources. (1) Biological contaminants include mold, dust mites, and rodent feces and dander. Non-biological include emissions from VOCs, smoke, and chemical vapors. In businesses such as healthcare, where no manufacturing occurs, the threat of infection is the main exposure risk.

Major IAQ Inventions That Led Up To ULPA filtration:

1823 – “Smoke Helmet”: protected firefighters from harmful coal and soot.

1854 – Gas mask: powdered charcoal was used as the filtering agent.

1908 – Electrostatic precipitator: collected and eliminated fumes and mists in factories and vineyards.

1942 – The HEPA (High-Efficiency Particulate Air) filter: based on the gas masks worn by soldiers which were made from a filter paper containing asbestos and cellulose fibers.

1970s – ULPA (Ultra Low Penetration Air) filter: was born after years of trying to create a higher level of indoor air cleaning, one that blocked even the smallest particles from reentering worker’s breathing space.

Today, both HEPA and ULPA filters are designed to catch airborne particulates and operate in a similar fashion. The filters are made up of minuscule strands of crossed and pleated glass fibers. When air is forced through the fine mesh filter, particles become trapped and are unable to reenter the atmosphere. But their similarities end here.

What researchers learned over the years is that a one-size-fits-all air cleaner isn’t suitable for all applications and that the size of the particles needing to be captured should determine the kind of filtration used. Fine particles need one kind of filtration, coarse particles, usually another.

Submicron Particulate

Fine particles or particulate matter (PM) is the sum of all liquid and solid airborne emissions 2.5 microns or less. Coarse particles fall between 2.5 and 10 microns.

A micron is a unit of measurement; 25,000 microns per inch. In industry, PM can be smoke and fumes from chemicals burning, or dust from metals and wood. In healthcare, smoke and dust are not as much a concern as are fine particles from viruses, bacteria, and mold.

In order to meet the minimum standard as set by the Department of Energy, HEPA filtration must trap at least 99.97% of all particles larger than 0.3 microns. (2) ULPA filters, on the other hand, are required to be 99.999% efficient and able to remove particles smaller than .12 microns in diameter.

To illustrate the size of particles, envision a strand of human hair. The average is somewhere between 50-70 microns. Dust, pollen, and molds are usually less than 10 microns in diameter. And fine particulates, such as viruses, usually measure under 2.5 PM. (3) This generally includes dust like pollen, mites, and pet dander. But airborne chemicals such as VOCs and mists from bacteria and viruses are too small to be caught by HEPA filters and pass right through. ULPA filtration was invented specifically for this purpose.


HEPA filters can remove fine PM as well as some coarser particulates. ULPA filtration traps the finest of PM – the ones that go right through a HEPA filter. But there are other considerations beyond capture capacity to be made before deciding what product to use for your office, lab, or facility.

Efficiency measures the ability of the filter (over the life of the product) to remove airborne particles. Since the ULPA traps more of the smallest particles than does the HEPA, it is considered more efficient.

And, resistance refers to the airflow capacity of matter as it moves through the filter. Since the ULPA filter media is denser, airflow is lower than a comparably sized HEPA filter, resulting in lower air circulation plus higher power use required by the unit blower to move air through the filter. This affects the life and longevity of the filter, making the ULPA less economical.

Industries and Applications

HEPA filters were designed for most industrial, military, and government applications, particularly in types of manufacturing where airborne particulate matter is constant. HEPA popularity has grown and is now common for home use ranging from bedroom air purifiers to vacuum cleaners.

ULPA filtration is used in situations where a more efficient means of capturing the smallest PM and preventing the spread of airborne bacterial and viral pathogens is important. ULPA filters are best suited for more critical applications in fields such as medical and healthcare, pharma research and manufacturing, biomedical labs, airline cabin purifiers, clean rooms, electronics, nuclear and aerospace industry applications.

When deciding between HEPA and ULPA filtration, one should start with safety. If both types of filtration methods can meet your particulate capture needs for a safe and healthy workplace, then take into consideration a unit’s efficiency and resistance.

To reduce the risk to manufacturing and healthcare workers, experts recommend a multi-layered approach to achieving a safe and healthy IAQ. This includes indoor air filtration. (4)

At Air Impurities Removal Systems, Inc., we protect our manufacturing and healthcare customers by providing them with high-quality products and IAQ expertise. Contact us today to speak to a clean air specialist.

Filter Change Frequency Is Based On Contaminant Type

With companies increasingly employing air filtration technology to remove environmental contaminant types like dust, smoke and chemicals, users are often asking when they should change their filters. To keep air cleaners working their best, you should regularly replace filters and absorption media to ensure peak performance and maximize worker respiratory protection.

Changing Your Prefilter or Primary Particulate Filter

When using Extra-All air filtration equipment, you should keep in mind that these devices have both a prefilter and a primary particulate filter, which work together to effectively capture impurities in the air. After a certain period, particulates may clog and slow down your system’s ability to filter out containments. In case you notice your filtration systems are not working as well, you should first check your equipment’s prefilter. If you detect the air flow is weak, change out the prefilter before moving on to the primary filter if your device still doesn’t work at full capacity.

Types of Contaminants Determine Frequency to Switch Out Filters

After determining whether you should switch out your primary filter, figure out the main contaminants your filter mainly works to prevent because this will factor into which filter you need to change and how often. When your air filtration equipment mostly filters out impurities like dust and smoke, the particulate filter might be the component you should focus on. On the other hand, if your system largely eliminates chemical fumes and vapors – which is the case for fume extraction equipment – you should use the right vapor removable module.
Users with gas and fume reduction filters will have to pay attention to the time between filter changes. Equipment that extracts light vapors primarily will have to be changed every 6 to 12 months. Equipment that handles more heavy vapors should be switched out more frequently with a new filter every 1 to 4 months.

With regular filter changes, your filtration equipment will work optimally to maintain a healthy environment for you and your staff.

No Matter Your Industry, HEPA Filtration Improves Indoor Air Quality

Building managers in various industries have a lot of tasks to oversee, including everything from ensuring elevators are working to lighting and electrical maintenance.

But perhaps no task is more important than maintaining the building’s air filtration system. In industries where workers are involved in labor-heavy tasks or craftsmanship, air quality levels are hugely important. For example, welding and cutting stones and concrete result in fine particles being thrown into the air.

Without the appropriate ventilation systems or filters, these particles can gradually become dangerous to individuals who inhale them on a consistent basis. Lung cancer, kidney disease and other illnesses are only some of the dangers these workers face as a result of these particles being in the air. Even office environments can be subject to dirtier air than one might imagine.

Air filters are only one component of keeping workers safe and healthy. To help ensure the cleanest air possible, the HVAC systems at worksites and offices should be outfitted with HEPA filters.

What is a HEPA filter?

Short for high-efficiency particulate air, HEPA filters are among the best a building manager can install and utilize.  Manufacturers of HEPA filters must meet strict requirements for the filters to be classified as such.

The U.S. Department of Energy requires HEPA filters to capture 99.7 of particles larger than 0.3 microns. Air particles are caught through either interception, impaction or diffusion.

Where can they be used?

The best aspect of Hospital HEPA filters is the number of places they can be used. Cars and airplanes have them, but so too do a number of important pieces of infrastructure.

HEPA filters are prominent in manufacturing plants, offices and perhaps most importantly, medical buildings. Hospitals, even the enclosed areas patients are kept if they are contagious, are filled with allergens, germs and other particles dangerous to an individual’s health. HEPA filters are an important defense to ensure hospital staff and visitors don’t contract serious diseases.

But as the days and months pass, HEPA filters will need to be replaced. If not, their effectiveness wears out.

As such, HEPA filters should be checked every six to 12 months for efficiency. Otherwise, new HEPAs will need to be installed.

Companies and building managers looking to improve the air quality should utilize HEPA filters. Doing so can help eliminate and catch dangerous allergens and pathogens. By contacting Air Impurities Removal Systems, companies can utilize HEPA filters no matter the industry.

Equipping Every Workplace with Air Filtration Solutions

Equipping Every Workplace with Air Filtration Solutions:

Poor indoor air quality can impact the productivity and health of workers across the nation no matter the workplace. To protect employees from contaminants specific to their work facility – from auto plants to hospitals – employers should consider investing in air filtration solutions that will replace air impurities with clean air.

Here are ways various workplaces can reduce occupational safety risks:

Air Filtration Solutions For Automotive plants

Problem: Auto plant workers often have to work with metalworking fluids that could endanger worker health by causing them to develop problems with their skin, allergies, or respiratory systems.

Solution: To capture these hazardous contaminants at the source, oil and coolant mist collectors operate using multi-stage air filtration solutions that will effectively extract air impurities before they reach workers’ breathing space.

Commercial laboratories

Problem: Lab workers may inhale dangerous chemicals and outside contaminants may threaten the integrity of their experiments.

Solution: Bench-top fume extractors and downdraft systems are standard in protecting laboratory workers and maintaining a safe and sterile workspace necessary to cultivate scientific innovation.

Hospitals Can Provide Their Workers With Air Filtration Solutions 

Problem: Health care workers and patients may be exposed to chemicals and impurities that could cause them to have adverse health effects and hospitals must follow clean room regulations.

Solution: Healthcare administrators have a variety of air filtration solutions to choose from to comply with regulations and maintain outstanding indoor air quality, including mobile fume extractors, ambient air cleaners and bench-top fume extractors.

Food Processing Facilities

Problem: Food producers often have to worry about the possibility of contamination from multiple sources, including the air.

Solution: Companies could install air purification and other air filtration solutions like bench-top fume extractors and downdraft systems to avoid the build-up of contaminants in ambient air that touch food as it is being produced.

Air Filtration Solutions For Government Facilities

Problem: Buildings owned by the federal, state, or local governments often contain valuable objects that may be affected by air impurities.

Solution: Facilities could implement ambient air cleaners and mobile fume extractors to preserve precious historical documents or artifacts for the long haul.