A primer on hygienically designed packaging machines: Part 2

By Harpak-ULMA
Posted In : hygienic design
Sanitary Machine Design Infographic

The ongoing implementation of the Food Safety Modernization Act (FSMA) has made prevention a key buzzword in the packaging industry. One of the fundamentals of sanitation management is designing equipment to facilitate easy cleanable access to optimize effectiveness and efficiency, including access for sampling and inspection. Analogous to Dr. Demming’s often quoted precept, “if you can’t measure it, you can’t control it”, the rule in Hygienic design is “If you can’t see it, you can’t clean it or sample it.” 

In short: two of the most important aspects of equipment sanitary design are: 

  • Visibility  
  • Verifiable “clean-ability  

Sanitary (hygienic) design must allow visibility of both the framework and product-contact surfaces during production without disassembly; or, when not in production, easy disassembly for cleaning, inspection, and reassembly without excessive downtime. A best practice in Hygienic design development is to incorporate cross-functional teams with shared ownership and responsibility for food safety, productivity, quality, clean-ability, and price.  

Machine Surfaces play a key role, since polished and bead-blasted stainless steel and extruded plastics will generally be more cleanable. Industry certifications, while not always required, provide assurance that the manufacturer has advanced sanitary-design education and that each machine conforms to specific standards. Another consideration is ease of equipment breakdown, particularly sans tools since they introduce opportunity for contamination and cross contamination. Finally, keep in mind that bolted-on components are less likely to be removed and properly sanitized.  

While the passing of FSMA hasn’t entirely translated into a significant increase in purchases of sanitary designed equipment, that may be related to the time and effort producers are still incurring around compliance documentation and traceability. While critical, such efforts fail to address the root cause – contamination. Producers that recognize the true risks and indirect costs associated with purchasing equipment that has not been hygienically designed will realize distinct advantages, not only in terms of compliance but in true productivity. 



Simply stated, hygienic machine design focuses on making a machine easier and faster to clean deeply – down to the microbial level – in order to avoid potential product contamination. At its most basic level this entails construction designs that minimize the opportunity for contaminant accumulation (nooks, crannies, and crevices) while enabling effective and efficient cleaning procedures for staff (i.e. achieve the desired result with minimized downtime). 

Sanitary design considers many different aspects of machine building: 

  • Construction Materials  
  • Corners  
  • Dead Areas  
  • Passages  
  • Covers  
  • Drainage  
  • Screw Threads  
  • Condensation Buildup  
  • Surface Smoothness  
  • Seals 

Any of these could harbor harmful microbial organisms or other toxic residue. 

Interest in hygienic or sanitary design has risen steadily based on two primary industry trends: 

First, modern food preservation techniques have become increasingly “mild” in nature, making processed foods more sensitive to microbial (re) contamination, thus demanding even greater production process controls.  

Second, rising consumer demand for “more” – both in terms of more product offerings and more packaging options. 

As producers increase the number of SKU’s and formats (single-serving, multi-pack, etc.), multi-purpose machinery that spans previously discrete applications are increasingly utilized. While this approach can blur the divisions between processing and primary, secondary and tertiary packaging zones to facilitate improved flexibility and efficiency, it also increases the need to look closely at hygienic design principles that mitigate contamination risk.  

Realizing strong, added control includes both machines designed for hygienic requirements, as well as correctly operated and maintained hygienic process lines. While both processing and primary packaging equipment has long been built to withstand washdowns, primary design considerations are focused on water ingress protection (IP) and the ability to sustain reliable performance after exposure to harsh chemicals. It is important not to confuse “washdown resistant” with “hygienic by design.” 

Currently USDA 3-A is regarded as the highest food equipment manufacturing standard, meaning equipment manufactured to it should be acceptable in both the US and Europe. Efforts are being made to harmonize the 3-A Sanitary Standards with the European EHEDG standards, however the differing methodologies used by each complicate the effort.  

The 3-A standards proffer fabrication specifications for materials, surface finish, angle radii, etc. EHEDG standards establish performance requirements and design guidelines rather than fabrication specifications and construction materials. This means European standards emphasize validation tests for cleanability, the ability to be sterile, bacteria tightness, etc. which also better address the integration of food processing and packaging machinery – which is becoming more commonplace in today’s multi-product packaging line methodologies. As an example of this difference in practice, a hex head nut not in the product contact area may be acceptable under EHEDG; however, 3-A may specify a domed head to eliminate the crevice.  

The sweeping Food Safety Modernization Act (FSMA), enacted in 2011 altered the FDA’s approach to food safety from a reactive system that responds to outbreaks, to one that works to prevent them. This act increased the FDA’s regulatory reach with an objective to proactively reduce consumer illnesses/injuries caused by contamination/ adulteration. While the major emphasis of FSMA is food production itself, packaging can be impacted in three areas: 

  • Sanitary design improvements  
  • Allergens cleaning  
  • Processing controls validation 

OEM compliance with FSMA cleaning, access, hygienic design and microbiological safety guidelines through enhanced sanitary design will enjoy an advantage. In fact, machines that employ innovative construction designs, automatic cleaning systems or other integral cleaning options that reduce the “time cost” incurred by equipment cleaning processes can create additional value for producers – something too often absent from OEM proposals. For many OEMs, building equipment that exceeds increasing USDA regulatory demands for equipment to be cleanable at microbiologically safe levels is the new normal. FSMA and brand protection are together driving food producers to increase food safety preventive control measures and due diligence. Performance considerations – such as cycle times and throughput – will always play an important part in the Total cost of Ownership calculation, but the foundation must be food safety. One serious incident could make it difficult or impossible to salvage a brand. 

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