How to Use Sanitary Machine Design to Eliminate Product Recall Risk

By Mike Terry
Posted In : design, Automation, packaging design, packaging automation, hygenic design, sanitary machine design, product recall

Recall. The word makes packagers at every level shudder.

Publicly admitting that your product is defective, dangerous, or even contaminated doesn’t just damage your brand’s reputation. It has serious financial consequences that can amount to hundreds of millions of dollars and impact your company and all the companies that integrate your product in their offerings worldwide.

For many producers, a product recall spells the end of operations, shuttering their production plants and putting hundreds or thousands of people out of work.

But for all the financial, supply chain, and employment woes that stem from a product recall, you must also consider the alternative. Defective, mislabeled, or contaminated products cause illness and sometimes even death.

In 2008, a major peanut butter manufacturer released product infected with salmonella, killing nine people and sickening hundreds more. Those involved were found guilty of 72 counts of conspiracy and fraud and sentenced to more than 20 years in federal prison.

Does the choice then become recall and lose millions or subject customers to potentially deadly products?

Thankfully, no.

There is a third option that prevents product recalls and simultaneously improves safety, sanitation, and Overall Equipment Effectiveness (OEE). That choice is sanitary machine design.

What Causes Product Recalls?

To understand the operational and financial benefits of integrating sanitary packaging equipment design, you must first recognize the root causes of product recall. The reasons for product recall, including offshore manufacturing errors, last-minute production changes, or lack of quality control, vary by sector, application, mandated government regulations, and severity.

According to experts, however, three major causes can send your product safety and financial security into freefall, endangering your operations and customers and force you to make the hard (yet voluntary) choice to proclaim a recall:


Contamination is the number one reason for product recalls in packaging. Bacteria and fatal foodborne viruses such as listeria and salmonella in meat, dairy, and produce affect 1600 to 1.5 million people annually, killing anywhere from 260 to 450 people on average. This bacterium originates from unsanitary conditions within packaging or harvesting plants, specifically upstream preparation and processing, portioning, or dirt and dust traps within the packaging equipment. Contamination can also result from a lack of quality control, proper machine sanitization, and inspection equipment such as bench scales, weigh modules, metal detectors, and x-rays.

Labeling & Coding Errors

More than 60 percent of all FDA recalls are due to incorrect labeling. Label creation and accurate coding are intricate processes, demanding proper satisfaction of required information at the point of manufacture as part of your quality control.

These elements include:

  •       Correct Product Identity
  •       Ingredient & Allergen information
  •       Nutrient Analysis
  •       Expiration Dates
  •       Lot & Batch Identification
  •       Regulatory Specifications

Missing one or several of these vital pieces of product information due to a manual inspection process, printing, or human error, can result in returned and rejected product or even an expensive recall.

Inadequate Training

Human error is one of the leading causes of compliance issues, product rejections, and recalls in the packaging industry. The more products produced, packaging formats utilized, and systems operated and maintained by staff increases the risk of error during all stages of production.

With changes in labor over the last two years, the availability of skilled and unskilled staff to properly execute the myriad of production responsibilities, including job set up, execution, inspection, changeover, and machine sanitizing, has decreased dramatically.

Without easily accessible legacy knowledge, expert training modules for disassembly and component washdown protocols, and established Codes of Practice (COPs), human error will continue to plague production and be a significant source of recall.

How Does Sanitary Machine Design Provide Product Recall Solutions?

Preventing product recall goes beyond simply responding to product or packaging defects and fostering a culture of safety and quality. Doing so protects your operations from recall and provides operational, financial, and efficiency benefits to improve operations long-term.

Accomplishing this, both in the spectrum of sanitary machine design and best operational practices, relies on integrating several key solutions across your supply chain and your production process:

Sanitary Machine Design

Integrating sanitary measures in your machine design, while more expensive in certain instances, can save you millions in recall prevention and help you increase production over time.

To start, implementing sanitary design from the onset answers essential questions regarding the risk assessment, sanitation requirements, function, and orientation of your packaging system:

  • Do you have any special requirements for your products, including allergen handling, bacteria prevention within your harvesting plants, product contact surface mandates, or clean room standards?
  • Do you have any written requirements or documentation for sanitary design, determined by internal Quality Assurance (QA) specialists or mandated by a governing entity such as the Food and Drug Administration (FDA) or the United States Department of Agriculture (USDA)?
  • How will the equipment be used, and what hygienic zone levels are required for sanitary operations?
  • Is wet clean or dry clean required?

Ascertaining the answers to these questions will determine the level of sanitary design for your machinery and, almost as important, become major contributing factors to the price.

Washdown vs. Sanitary Machine Design

Choosing from a range of sanitary equipment design options better attunes overall sanitation efforts to your budget and packaging application. These design options generally fall into two categories: washdown and sanitary design.

Washdown Equipment Sanitation

Choosing washdown sanitation design allows you to utilize whatever water or solution sources are available at your facility to clean your equipment after each production cycle (ideally). This option often offers the lowest price, unrestricted wet sanitation processes, and removal of packing machine components for cleaning between shifts. However, the risk of product contamination and possible product recall is higher.

Comprehensive Sanitary Machine Design

Opting for comprehensive sanitary design for your packaging equipment provides the most control over product quality and better system efficiency, albeit at a higher price point.

For instance, some larger companies detail 700+ page documents on the exact product, system, and environmental requirements to custom build their sanitized packaging systems and reduce the recall risk to zero. Producers can opt for the specialized complexities of sanitary design – specialized finish on the stainless-steel frame, grease removal units, calibrated radii, foam cleansing, 180-degree tented steam cleaning – to ensure the most precise sanitization and operational control for their applications and products.

The price differential between the two? Up to $150,000 per machine. Comparing that expenditure to the cost of damage control and stock share value resulting from a product recall? Those values always come down to a question of customer need.

Customized Sanitary Machine Design          

The top packaging OEMs provide the best of both worlds, offering customized sanitary design based on budget, facilities, application, and risk. With this level of sanitary machine construction, you can remove each washable component of the system – conveyor, conveyor top, chains, belts, sealing systems (on a flow wrapper for example) – with minimal tooling and according to your specifications and requirements.

This capability allows this component disassembly, removal, and sanitization process to be completely customized to the individual application. Additionally, it preserves product quality, provides better process control, and makes the system easier to clean in less time. By opting for customized sanitary design, you save more and gain distinct production advantages in ways washdown and full sanitary design cannot offer:

  • Reduced planned downtime for cleaning, inspection, and recleaning
  • Increased production performance and better OEE
  • Improved throughput
  • Cost savings on customized sanitary design

Ancillary Equipment

Sanitary machine design solutions are not limited to your main packaging line system customization. Integrating proper ancillary equipment – gas analyzers for correct Modified Atmosphere Packaging (MAP), printers for accurate static and in-line printing and labeling, metal detectors, and x-ray machinery – provides optimized levels of control for process and product quality. These components also provide opportunities for more streamlined automation for primary packaging, case packing, and palletizing.

Without these components as part of your sanitized design, contaminated product may slip through during a production cycle, get packaged, and shipped out. Once delivered to retailers, it is too late. The entire batch from that cycle must be recalled, or you risk injuring or killing a customer and placing the liability solely on your company.

Employee Training in Sanitary Machine Design, Maintenance & Operation

Superior packaging machinery is designed to meet the industry’s highest hygienic standards. Open-slot layouts eliminate dirt traps and hidden areas. Stainless steel frames and cantilever execution help to prevent dust accumulation and offer easy access for cleaning and maintenance, even in the harshest environments.

However, these features are only half of the equation. Utilizing sanitary machine design to your advantage also includes optimized, documented training for your employees on machine component disassembly, washdown, and equipment testing. Packaging equipment is standardized in execution, but how the machinery comes apart for sanitization is customized to your specific application.

When staff understand their responsibilities and successfully execute these tasks, they become an integral part of the recall prevention solution. Established staff training and protocols improve product quality, reduce “never events” (easily preventable labeling and packaging mistakes that trigger recalls or management intervention), and increase production efficiencies at nearly every packaging stage.

Internal & External Inspection

Yet even the most perfectly designed sanitary system and diligent employee requires checks and validations to ensure desired quality and production levels. Therefore, product and equipment inspections should span your entire supply chain to ensure safety and compliance according to internal and external standards.

It is not wrong or uncommon to make product changes, even last minute, to cut costs. However, without the appropriate inspections, you could risk creating defective product and triggering a recall.

To counterbalance this, organizations, such as the FDA and the USDA, enforce strict inspection protocols and audits – often daily – to protect the well-being of the nation’s food supply and citizens. In almost every sector – meat, dairy, medical packaging – and across every application – flow pack, tray sealing, thermoformer, vertical packaging machine – these audits include disassembly of machinery, swabbing entire (harvesting) facilities, and unplanned downtime for recleaning and redressing any issues. This process can have an enormous financial impact on your production revenue, even outside the need for a recall.

For example, an inspection could yield that you are out of sanitation compliance set down by the FDA or USDA. If your packaging staff arrives at 6:30 am and does not begin packaging product until 10:00 am, that is 3.5 hours of unplanned downtime you must allow for disassembly and recleaning.

What will that cost you? Let’s look at the math:

10 people on the line x 3.5 hours of downtime per person x $24 per hour (on average):

$840 in stranded labor and lost production revenue that morning alone.

That may not seem like much for a single instance. However, when you multiply that by the number of occurrences in 260-300 working days per year, without the benefit of inspection or higher levels of sanitary machine design, it could cost you HUNDREDS OF THOUSANDS OF DOLLARS in lost revenue per annum.

Integrating a specific level of sanitary design according to your production eliminates that downtime, extra production time, and overtime personnel hours. In addition, it saves revenue, and makes disassembly, inspection, and cleaning easier. Incorporating sanitary design augments and streamlines the internal inspection and training process conducted by your Preventative Controls Quality Individual (PCQI).

Investment in Packaging Automation

Sanitary machine design eliminates contamination and streamlines production. Ancillary equipment establishes a multi-layered system of product checks to ensure quality, safety, and compliance. System automation works in tandem with these features, helping to enhance the production process and reduce the second largest contributor to product recalls: human error in coding, packaging, and labeling.

Incorporating packing line automation, especially in high-risk environments, serves as an essential part of your Enterprise Resource Planning (ERP). While some producers may find automation cost-prohibitive at first glance, it better prevents recall and provides higher ROI over time through various operational functions:

  • Improves end of line vision inspection systems
  • Optimizes label and coding accuracy and product quality control
  • Replaces strenuous manual labeling and documentation processes

By investing in packing automation and customized sanitary design for your machinery, you’re committing to that all-important culture of prevention and accountability and expertly setting up your operations for future scalability and digital transformation.

Put Recall Prevention & Sanitary Design Into Practice

Product recalls can happen at any interval from production to retail. They derive from various sources, including contamination, human error, and incorrect labeling, and there is no surefire way to eliminate all recall possibilities.

However, no matter the origin, you must consider:

“Can my operations afford to simply react to defective product with an expensive recall or worse endure the darker consequences of not recalling product that is dangerous to my customers?

Neither scenario is ideal, and the stakes in the food, beverage, and medical packaging industries are just too high.

You need practical, preventative processes across your supply chain and sanitary machine design to proactively address these concerns before they take shape. Sanitization management, label accuracy, proper training, and thorough inspection are transforming operations as critical components to mitigating customer harm, safeguarding your brand, and preventing recall on a global scale.

If you want to know more about sanitary design and what it can do to prevent product recall, talk to our experts at Harpak-ULMA Packaging. Our teams provide the customized equipment design experience you need to achieve higher productivity and a culture of safety and prevention while maintaining quality, brand protection, and total compliance.

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