In today’s world, headlines about food contamination have become alarmingly common. For manufacturers, the cost of a single recall averages a staggering $10 million. Beyond the financial impact, there’s an immeasurable cost to consumer trust, with buyers growing increasingly wary of products associated with contamination. This not only affects the brand’s bottom line but also its long-term reputation. Manufacturers in this space are looking for products that help them mitigate these risks.

The urgency to address this issue is highlighted by alarming statistics: food recalls have hit a five-year high, increasing by 19.6%, while pharmaceutical recall events have surged by an unprecedented 42.4%, marking the highest in over a decade. Additionally, 55% of FDA recall events are attributed to foodborne illnesses, foreign matter contamination or chemical contamination. These numbers underscore the critical need for enhanced safety measures across industries.

It’s not getting any easier to mitigate these risks. So, what actions must be taken to ensure the highest standards of cleanliness, contamination control and long-term reliability in manufacturing? One key step is prioritizing the use of products that are hygienic by design in environments where preventing contamination is critical.

Not all products on the market are developed with hygiene and contamination control in mind. Manufacturers must commit to investing in adequately designed solutions that meet stringent hygienic standards. Equally, specifiers play a crucial role in selecting products that align with the demands of their environments. Choosing subpar equipment or materials not specifically designed for this environment can lead to disastrous consequences, from costly operational downtime to product contamination.

Robroy Industries prioritizes the importance of hygienic design and regulatory compliance in our product development from the start. As strong proponents of educating our customers, we empower them to make informed decisions when specifying products for their facilities. By prioritizing and applying hygienic design, and partnering with product manufacturers that understand the solution, food manufacturers can not only meet today’s heightened safety expectations in preventing contamination but also build trust and resilience for the future.

Critical principles of hygienic design

The stakes have never been higher, but the solutions are clear. Investing in properly designed, hygienic products is no longer optional—it’s essential for safeguarding both consumers and the bottom line. With contamination events at record highs, every design aspect, from material selection to ease of cleaning, plays a vital role in preventing contamination and ensuring regulatory compliance. By integrating these principles into equipment and facility design, manufacturers can minimize risks, enhance operational efficiency and build consumer trust. Now is the time to act decisively to prevent recalls, ensure the longevity of operations and uphold the highest standards of safety and quality.

Material selection:

• Non-reactive, corrosion-resistant materials: The materials used should not react with processed products, especially food or pharmaceuticals. Stainless steel (especially grades 304 and 316) is commonly used for its durability and resistance to corrosion, stains and rust. It’s also easy to clean, mechanically stable and doesn’t harbor bacteria.
• Non-toxic materials: Material composition is critical. It is important that the products used in a manufacturing site—in direct or indirect contact—do not contain toxic materials.

Ease of Cleaning:

• Smooth, nonporous surfaces: All surfaces must be smooth and sealed to prevent liquid or food particles from entering a sealed unit. This includes designing surfaces without rough textures, joints, crevices or holes that could provide harborage for contaminants.
• Accessible for cleaning: Cleanability is a very important hygiene requirement regardless of the cleaning methods. Improper or insufficiently cleaned equipment cannot effectively be disinfected. Equipment and factories which are difficult to clean require more severe cleaning procedures, use of more aggressive chemicals and longer cleaning times, resulting in higher costs and reduced production availability.
• Washdown design: The design must allow for effective washdown procedures. The product will be exposed to several cleaning agents, so it is important that the construction of the product can withstand these cleanings and not cause possible contamination. The equipment must be able to resist extensive temperatures and pressure washing for deep cleaning. These temperatures can range from 160°F to 180°F for a hot washdown.

Avoidance of contamination:

• No crevices or gaps: All joints and seams should be smooth, without gaps or crevices where bacteria, dirt or liquids can accumulate. This reduces the risk of contamination.
• No stagnant areas: Avoid designs that create dead zones, which could trap food, liquid or air and potentially breed bacteria. All surfaces should be sloped appropriately to shed moisture, and liquid should not be allowed to pool.
• Minimized exposure: Where possible, product-contact surfaces should be kept as straightforward as possible. Avoid the unnecessary use of seams, joints and fittings that could create places for contaminants to hide.

Design for accessibility:

• Easy inspection and maintenance: Hygienic designs prioritize systems that allow easy inspection and maintenance. Equipment should be designed so operators can visually check for cleanliness and hygiene, and maintenance tasks should be simple.
• Removable parts: Components needing regular cleaning or replacement, such as filters, gaskets and seals, should be removable and easy to clean or replace.

Minimizing cross-contamination:

• Flow of materials: The design should minimize the chance of cross-contamination by clearly separating raw and finished materials or using physical barriers between different stages of production.

Drains and ventilation:

• Drains: The product should have proper drainage to prevent liquid or product from accumulating inside a unit.
• Ventilation: Hygienic designs need to allow moisture and condensation escape and, therefore, should be ventilated.

Compliance with regulatory standards:

• Industry regulations: Hygienic design should comply with industry standards and regulations, such as those of the Food Safety Modernization Act, FDA and NSF. Robroy takes recognized industry standards and independent third-party certifications into account during product design, ensuring worry-free compliance.
• Good Manufacturing Practices (GMP): Adhering to GMP guidelines is essential. These include ensuring sanitary conditions during manufacturing, maintaining cleanable surfaces and maintaining staff hygiene.

Connection points:

• Permanent metal-to-metal joints should be continuously welded and free from imperfections. Threaded connections should comply with local regulations. Connection of threaded joints should be made to ensure that there are no exposed threads.

These principles and more are a part of facility or equipment design in any FDA- or USDA-regulated facility. However, these principles have not consistently been applied to all the critical components needed to run an optimized facility.

Selection of hygienic products

Considering all these principles, Robroy Industries designed the first ever hygienic stainless-steel electrical conduit and fittings raceway system, Robroy Stainless. Robroy Stainless is engineered to protect your electrical system in demanding environments against corrosion, while maintaining cleanliness, safety and reliability. The sealed system utilizes an innovative design with curved geometry and smooth surfaces, creating no areas for bacteria or liquid to accumulate. Built with 304 and 316 stainless steel, it resists corrosion and stands up to harsh cleaning protocols and chemical exposure. Additionally, laser-marked labels meet facility hygienic requirements, eliminate foreign matter contamination risk and save contractors time as there are no adhesive labels to remove. The complete raceway system solution complies with both UL safety standards and hygienic principles.

In addition, Rocket Rack, a sanitary support system, is the first platform for electrical and mechanical infrastructure designed and certified for hygienic compliance. Rocket Rack offers factory engineered and fabricated solutions that eliminate the need for field cutting, welding or drilling. Preconfigured assemblies enable fast, efficient installations, and the patented slot design on racks allows for changes and future additions, helping projects stay on schedule and within budget. Its design supports hygienic standards, featuring easy-to-clean surfaces ideal for food and beverage facilities, as well as other industrial applications.

Most importantly, both systems are designed to align with UL, EHEDG, 3A and NSF standards, providing peace of mind in meeting strict industry regulations.

The importance of a fully hygienic system

To maintain the integrity of a hygienic system, every component must adhere to hygienic design principles. Using a mix of hygienic and nonhygienic products in the same installation can compromise the entire system, as the weakest link determines overall performance. For example, while a hygienic conduit body may meet all design and safety standards, pairing it with nonhygienic components risks contamination and system failure. Ensuring all components are hygienically designed is essential for achieving a reliable and effective solution of the installed system.

Conclusion

The advantages of implementing a hygienic stainless-steel design are substantial. In industries like food and beverage manufacturing and pharmaceuticals, where quality production is paramount, it is essential to prioritize the installation of the right products at manufacturing facilities. A relatively small investment in systems that are designed and certified as hygienic can yield substantial savings by preventing contamination that could otherwise cost millions of dollars and irreparably damage consumer trust. With proper controls and the right solutions in place, these risks are preventable, paving the way for safer, more reliable production processes.