One of the biggest concerns bakers have when it comes to purchasing new equipment is sanitary design. But as regulations carrying out the Food Safety Modernization Act (FSMA) near completion, sanitation is not just an issue pertaining to new equipment purchases — it’s a challenge for existing equipment as well.

Make no mistake: The weight of responsibility for FSMA compliance will rest more on the shoulders of the food processors than the equipment manufacturers. So, as bakers’ questions and concerns continue to grow, Baking & Snack reached out to Contributing Editor Joe Stout for advice on how pending ­regulations will affect the design of new equipment, require adjustments to existing equipment and force bakers to take into consideration myriad factors when deciding to purchase, upgrade, renovate or repair.

Baking & Snack:  What exactly does ’clean equipment design’ mean in a bakery setting?

Joe Stout: Clean equipment design is a preventive approach to allow open access to observe, inspect, reach for cleaning and reach for sampling. Clearly with dry cleaning, where water and clean-in-place (CIP) is not typically used, one must rely on more traditional methods. If you can’t see it, can’t reach it, can’t sample it, then you can’t clean it or verify its cleaning. This is most critical in bakeries that do manual cleaning. Longer production runs could allow product to accumulate in hidden areas unobserved by operators, quality assurance or sanitation. This is vital from an allergen, microbial and pest control perspective.

How will regulations under FSMA affect the design and engineering of bakery equipment?

FSMA’s proposed preventive control rules will be mandatory for the food processing industry, including bakeries. Equipment design, although not regulated at the equipment manufacturer (OEM) level by the Food and Drug Administration (FDA), is clearly the responsibility of the food processor being regulated.

Think of it this way: If and when things go bad on a given Friday afternoon, FDA will not pursue the OEM if an issue is the result of poor equipment design. Instead, it will look to the processor who decided to purchase equipment that was not suitable or, worse yet, not cleanable.

To be honest, it will be hard to gain relief for judgments for poor equipment design because it is the processors’ responsibility to know the profile and risks of the products they make and monitor all food safety parameters including equipment design. This just brings it back to food manufacturers as the responsible entities. A key learning and focus is that processors should buy well-designed, easily cleaned equipment and maintain it in sanitary condition through good programmed cleaning and maintenance.

So yes, FSMA will impact equipment design — at the request of the processors who essentially “own” the design of the equipment they choose to use.

What are you hearing about FDA’s coming changes to current good manufacturing practices (CGMPs) that could affect the design and use of bakery equipment?

There are and have been existing criteria for equipment design in numerous sections of the CGMPs. What makes it different in the FSMA era is FDA’s improved access to and visibility of records including sanitation standard operating procedures (SSOPs), pathogen results, pre-op inspections, allergen changeover validations and other critical programs and records that could indicate equipment is not cleanable or maintained in acceptable sanitary condition.

We’ve noticed more OEMs “simplifying” the engineering of their bakery equipment to enhance access for cleaning. Why is this happening? What makes it possible?

In the past several years, some OEMs have been simplifying equipment designs to allow better access and cleaning at the request of processors. To be honest, more processors need to request that equipment be designed and fabricated to reduce sandwich points  (two materials joined together mechanically but not ­hermetically sealed) and other hard-to-clean areas.

OEMs have the opportunity to be proactive and get ahead of the coming demand for improved design, rather than play catch-up in the future. I think there is a communication gap between end users and OEMs.

Buying equipment is unlike buying a gallon of milk, where you take it off the shelf and head to the cashier. There needs to be deliberate discussions on the overall design of equipment regarding SSOPs, time required for cleaning, the environment in which the equipment will be placed and utilities available for cleaning. The suggestion is to have good discussions before you ever see the OEM “cashier.”

The baking industry has a large inventory of equipment already in service, some of it rather old and difficult to keep clean. What factors relating to cleanability should a baker consider when evaluating the continued use of such equipment?

Yes, there is a significant installed base of legacy equipment currently in use in the industry. I would not call the equipment bad, but it does have challenges for cleaning and maintenance beyond what would be observed with newer, better designed equipment. The key is to understand the issues and develop the “right sized” programs and cleaning frequencies to address potential risks.

I have been evaluating equipment design for many years, and I have yet to see a perfect piece of processing equipment. However, most new equipment is closer to perfect than older designs.

The best way to identify issues of legacy equipment is to complete a design review using the Grocery Manufacturers Association (GMA)’s Ten Principles Design Checklist for low-moisture foods. Once the faults or risk areas are identified, it is necessary that “at risk” areas be included in the SSOPs for routine cleaning. In addition, another list should be created to call out areas that need deep cleaning (less frequent than weekly — perhaps monthly or quarterly). This will ensure that identified risk areas are adequately cleaned. This is what makes newer equipment much more appealing.

What are the most logical applications for CIP technology in the bakery?

For bakeries that are primarily dry, wet cleaning using CIP designs on the equipment is not common. However, dry cleaning tools such as vacuum systems, dry-steam systems and multiple hand cleaning tools can be purchased to facilitate easy cleaning. For the wet areas such as spiral freezers, wet CIP can still be a useful tool to keep the belts clean and freezer environment clean.

What trends are you seeing in the sanitary design of bakery equipment?

An increasing number of OEMs are using sanitary design standards, of which there are many. My favorite is the GMA Design Principles and Check List that can be used jointly by OEMs and processors as a dialogue tool to arrive at a better design before fabrication. In the past several years, I have seen many OEMs attend hygienic design training courses. The trends are obviously moving toward open access, smooth and homogenous surfaces, no harborages and tool-free maintenance as well as being compatible with potential dry cleaning technologies.

As bakeries become more automated, how should equipment be designed to accommodate fewer people on the shop floor and, thus, larger work stations to be kept clean by those operators?

Automation in bakery plants will reduce labor costs with centralized work stations established. This trend requires easy and efficient cleaning of equipment. One of the benefits of hygienically designed equipment is to improve cleanability and reduce cleaning time so that it will be able to meet the requirements with fewer laborers during production.