[ October 8–11, 2019    McCormick Place    Chicago, IL USA ]

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Pharma Manufacturing

As the Food Processing Suppliers Association, our main focus is, of course, the food industry.

But many of the equipment manufacturers that supply the food industry also supply other markets. So, we thought it would be interesting to branch out and take a look at current trends and challenges in some of these other markets and see how they compare to what’s happening in food.

For this broader perspective, we spoke with two representatives from Nilfisk Industrial Vacuums, Scott Boersma and Gerard Geiger.

Boersma was born into the food industry. His father was influential in the bakery sector. Boersma himself started designing systems for the family business, Dunbar Systems, when he was 19. Today, he’s Nilfisk’s Business Development Manager for the Food Industry.

Geiger started with Nilfisk three years ago as a district sales manager for Delaware, New York, and part of Connecticut. That region is heavily focused on pharmaceuticals. Today, Geiger is the company’s Business Development Manager for the Pharmaceutical Industry.

We learned that even though the specifics are different, many of the challenges facing food and pharma are the same. In this article, we explore three of them:

  • Complying with new regulations
  • Preventing product contamination
  • Understanding and educating customers

Complying with a growing list of regulations

Both Boersma and Geiger said that many of their customers are concerned about keeping up with what seems like an ever-shifting landscape of compliance regulations. Because things are always changing, often companies aren’t even aware of some of the rules that exist. That is, until they get slapped with a noncompliance penalty.

Let’s explore a few of the familiar, and perhaps not so familiar, regulations in effect today.

Everyone knows about FSMA, but what about combustible dust?

Many of the articles in this series have focused on the challenges of complying with the Food Safety Modernization Act (FSMA). With the first deadline coming into effect on September 19th of this year, FSMA has certainly been top-of-mind.

But FSMA isn’t the only set of laws on the block.

Food and pharmaceutical manufacturers must also meet Current Good Manufacturing Practice requirements, as well as OSHA health and safety requirements. Especially since OSHA fines recently went up 78% and increase incrementally going forward, these regulations can’t be ignored.

When it comes to OSHA and worker safety, a major hazard that food manufacturers have overlooked is combustible dust.

Never heard of combustible dust? You aren’t alone. Many food processors aren’t aware of the huge problems that can be caused by these tiny particulates. But nearly every ingredient used in food processing has the potential to become combustible dust. This means that it can catch fire and explode when mixed with air.

Boersma says that “of all industries, the food industry is getting hit the hardest by combustible dust.” The statistics bear this out. Research through OSHA’s National Emphasis Program (NEP) found that food dusts are present in 23% of all combustible dust incidents. The food products industry is also responsible for 24% of all incidents across all industries.

The food industry’s most famous incident happened in February 2008 at the Imperial Sugar refinery in Georgia. It killed 14 people and injured more than three dozen others. This year there have been combustible dust incidents at a spice factory, a feed mill, and a farm, to name just a few.

While most food companies are scrambling to comply with FSMA, Boersma has noticed a “weird paradox” in attitudes toward combustible dust regulations.

On the one hand, he says that some companies are on the “high end of awareness and compliance.” They recognize the danger and are actively doing something about it. They’re guided by the philosophy, “We’re not willing to take one ounce of risk.” On the other hand, many companies don’t seem worried. This is likely because they aren’t aware of the risk in their plant or of the potential consequences of an incident.

However, that will change as OSHA ramps up its enforcement game.

OSHA doesn’t yet have a combustible dust standard, but they’re working on it. (The current projection is that a standard will be in place by 2018.) However, the agency can and does still issue citations for combustible dust under 29 CFR 1910.22, which is the main OSHA standard for housekeeping.

Boersma also cites the December 2015 court decision allowing enterprise-wide hazard abatement. As he explains, “this means if you have four facilities doing the same type of production, and OSHA finds a violation at one plant, you can automatically be fined for the other three plants, sight unseen.”

Overall, Boersma believes that the one-time increase in OSHA penalties, the incremental growth going forward, and the enterprise-wide hazard abatement ruling mean food processors will need to pay a lot more attention to combustible dust in the very near future.

If you’d like a preview of what the OSHA standard might look like, check out the standards for the food processing industry issued by the National Fire Protection Association (NFPA). Compliance with NFPA codes is voluntary in most cases. However, OSHA relies heavily on the NFPA when drafting its own standards, occasionally borrowing language directly from NFPA guidelines.

CGMPs keep pharma safe, pure, and effective

On the pharma side, manufacturers have just as many regulations to contend with. The main standard here is CFR 211: Current Good Manufacturing Practice for Finished Pharmaceuticals. While the document is complex, Geiger notes that it essentially boils down to three things:

  • The facility must be safe.
  • The environment and the end product must be pure.
  • The manufacturing process must be effective.

Again, both OSHA and NFPA also help ensure drug manufacturers meet the requirements of safe, pure, and effective.

And these standards are in constant flux. In fact, the NFPA just recently issued NFPA 652: Standard on the Fundamentals of Combustible Dust. This is in addition to the industry-specific standards already on the books.

How to deal with changing requirements

While these regulations improve the safety of food and pharma products, and the workers who make them, they also create complexity.

Boersma observes that all of these compliance requirements are pulling food manufacturers in many directions. “It becomes a question of what’s the right thing to do almost on a day-to-day basis.” He notes that while companies certainly want to do the right thing, they also need to make a profit. As a result, many take the approach: “What can we comply with and not have to shut our doors?”

For companies that may be behind the curve in terms of investment in things like sanitation equipment, spending money on something that doesn’t affect the bottom line day to day can feel like a risk. But the risk of doing nothing (which could result in a recall) is potentially much higher.

According to Boersma, this is the balance that the food industry is constantly struggling with: “How do we still maintain the level of environmental health, safety, hygiene, and so on, within a reasonable cost?”

Geiger finds a similar pattern in pharma. Although this industry isn’t currently dealing with anything as sweeping as FSMA, many facilities were built 15 or 20 years ago. These older plants may not be equipped to meet today’s strict standards. To stay up-to-date, manufacturers are looking at both their equipment and their facilities as a whole to ensure they’re capable of handling and processing combustible dust particles.

One answer for manufacturers is to lean more on their suppliers for information about how to achieve cost-effective compliance. That puts the onus on suppliers to understand the regulations and their customers’ needs. We’ll return to this point later in the article.

Preventing cross-contamination

A main goal of regulatory compliance is ensuring safety — for employees and for consumers. We focused largely on combustible dust in the previous section because it’s an area where regulations are increasing and awareness is lacking.

But if you were to ask food and pharma industry leaders to name the worst thing that could happen in their facilities, they’d probably say cross-contamination.

Traveling microorganisms in a food plant can mean a Listeria outbreak or allergen exposure. In pharma manufacturing, traveling dust can result in toxic active pharmaceutical ingredients (APIs) getting into products where they don’t belong.

Bringing housekeeping practices into the 21st century

Cross-contamination spells very bad news for food companies. This is especially true as more inspections, new testing procedures, and increased regulation mean more recalls. In fact, in Q2 of this year, the FDA recalled 80x more food units and 45x more pounds of food than in Q1. Contamination recalls alone were 167% higher.

With the Preventive Controls rule, FSMA shifts the industry’s approach to food safety from reactive to preventive. It requires companies to identify all food safety risks and take steps to mitigate them before they cause problems.

Preventing cross-contamination requires effectively collecting and removing all contaminants before they become widely dispersed. As a leading manufacturer of industrial vacuum equipment, this is something Nilfisk knows quite a lot about.

Most, if not all, food companies have a housekeeping program in place. The question is whether or not that program is effective.

Traditional housekeeping methods like sweeping or even using a shop-style vacuum can often do more harm than good. You can sweep dirt and other contaminants into a pile, but not without generating a cloud of dust. Similarly, shop-style vacuum cleaners may suck up the dust. But, without adequate filtration, they end up just exhausting that dust right back into the air.

An industrial vacuum cleaner with multi-stage filtration solves this problem. By collecting pathogens, controlling the spread of allergens, and filtering the exhaust, an industrial vacuum cleaner not only collects and removes harmful contaminants, but also keeps them from returning to the processing environment.

Boersma notes that proper housekeeping is not only effective. It also reduces the overall time to clean. Thus, even though an industrial vacuum cleaner certainly costs more than a broom, the total cost of ownership (TCO) is actually lower. First, vacuuming decreases the likelihood of cross-contamination, which reduces your chances of a recall. Second, vacuuming takes less time than sweeping, so there’s less downtime.

When thinking about purchasing modern sanitation equipment, Boersma urges manufacturers to consider the bigger picture. A vacuum cleaner doesn’t just keep your facility clean. It also helps keep you safe and compliant, boosts product quality, and keeps your production lines running longer.

Keeping toxic materials contained

Many of the same benefits are applicable in pharma, where dust contamination is a main cause of cross-contamination. And the stakes are just as high, as many companies today manufacture very highly potent and toxic drugs.

Geiger notes that, in addition to safety and compliance, there is growing pressure in the industry for manufacturers to display a high level of corporate responsibility. That means both being good stewards of the environment and ensuring that the product they deliver to the end user is safe, pure, and effective. On top of that, “companies want to have a good brand image.”

Geiger recommends that companies take a multilayered approach to preventing cross-contamination:

  • Identify the source. First, determine where the dust is coming from. The best solution is to capture it immediately to stop it from spreading.
  • Implement process controls. Once you’ve identified the problem, take several steps to solve it. A variety of process controls can be implemented in pharmaceutical environments, including:
    • Equipment modifications (e.g., encompass equipment in a shroud or some other protective layer to keep dust contained)
    • Engineered control systems (e.g., install a ventilation system to evacuate the dust, use a vacuum or cyclone separator to capture the dust before it gets into the main area of the plant)
    • Facility design (e.g., control the airflow and flow of employees into and out of facilities, control entrances and exits of manufacturing suites)

Again, the cost of implementing proper dust control measures is far less than the cost of doing nothing. Like Geiger says, “a recall can lead to a PR nightmare and bankruptcy.”

Understanding and educating customers

Finally, Boersma and Geiger emphasized the need for equipment suppliers to play the role of educator. This doesn’t just mean sending customers product brochures. It means going into the field and asking what customers need. It means their problems and helping them find solutions.

Boersma says:

“Everybody thinks they have the best product and everybody needs their product. But that’s not the case. As suppliers, we’ve been product-focused for too long. We come into an industry with our own agendas. That needs to change. The industry has some needs, and we need to understand those needs so that we can adapt to meet them.

You can’t understand what a customer needs from a chair in your office. You have to go walk and live and breathe what they do every day.”

He emphasizes that suppliers need to focus on adding value, not just selling products. This is especially important as merger and acquisition activity means companies are looking to consolidate the number of vendors they buy from. Boersma notes, “Companies don’t want to buy from too many vendors. They want to buy from just a few vendors that they trust.”

For Nilfisk, a lot of that value comes from the follow-up support they provide, which includes education, training, and a lifelong relationship. “It’s an ongoing process,” says Boersma. “Our sales process starts with an onsite visit, and we continue to provide support from the day we make first contact to the day our customers retire.”

Boersma’s comments are in line with the sentiments we’ve heard from many other interviewees. Both manufacturers and suppliers are interested in developing closer relationships with each other. In this ever-changing world, that is the only way companies will survive and thrive.

PROCESS EXPO brings manufacturers and suppliers together so they can develop those essential relationships. Register today to reserve your spot at the show.