Cross-Contamination Control Strategies Part 2: A Focus on the Hygienic Design of Equipment and Premises 

In Part 1, we covered the top inspection violations and audit non-conformances related to equipment and environmental sanitation. In this blog, we will explain why hygienic design matters when considering the selection and installation of food processing area equipment and facilities. Poorly designed equipment and premises can adversely affect the sanitary conditions of a food production site and increase the chances of product contamination.

This blog offers practical and effective strategies that food manufacturers can adopt to minimise the risk of cross-contamination and improve the hygienic status of their food processing environment.

 
Hygienic Design: Regulations and standards

According to Codex Alimentarius, food safety is a “non-negotiable” priority for sites that process, handle, store, and/or transport safe and wholesome food products for their intended stakeholders, including the consumers (1). Moreover, food hygiene and sanitation requirements are important food safety controls, and among these, equipment and facility structures that are designed and constructed with appropriate materials, according to the principles of good hygienic design, can significantly and positively impact food safety (2).

Regulations, globally and locally, are increasingly mandating food facilities to look for cleanable equipment and facility options to minimise the risk of persistent pathogen presence, cross-contamination issues, and product waste or food recall. For instance,

(a) EU legislation contains directives and regulations on hygienic design, materials of construction, hygiene, and cleanability requirements, some of which are:

• Directive 2006/42/EC - machinery directive
• EC 1935/2004 - framework regulation for food contact materials
• EC 10/2011 - plastics regulation
• EC 2023/2006 - GMP for materials and articles intended to come into contact with food
• EC 852/2004 - hygiene of foodstuffs regulation

(b) With the passage of the FDA’s Food Safety Modernization Act in 2011, more than ever, federally inspected sites are required by US regulations to utilise equipment and facilities of good hygienic design:

21 CFR 117.40 - Equipment & utensils design and maintenance -

Equipment and utensils must be designed and constructed to be adequately cleaned or maintained to protect against contamination.

21 CFR 117.20(b) - Plant construction and design -

The facility must be constructed or designed to facilitate maintenance and sanitary operations

Note: FDA citation violations related to the requirements above are among the top 10 reported. In 2023 (3), there were 139 violations of 21 CFR 117.40 and 106 violations of 21 CFR 117.20(b).

The Global Food Safety Initiative (GFSI) is a coalition that brings together food retailers and manufacturers to help ensure safe food for everyone globally. GFSI Benchmarking Document Version 2020, includes the following industry scopes covering hygienic design (4):

• JI = Hygienic design of food buildings and processing equipment for constructors or manufacturers
• JII = Hygienic design of food buildings and processing equipment for users

GFSI-benchmarked food safety standards include those operated by BRCGS, SQF, FSSC 22000, and IFS. Each now contains specific references to hygienic design requirements. Some key sections are highlighted below:
 

BRCGS

4.6 - Equipment

Section 4.6.2

The design and construction of equipment shall be based on risk to prevent product contamination, e.g., use of correct seals, impervious surfaces or smooth welds and joints, where they are exposed to the product and could otherwise result in foreign-body, microbiological, or allergen contamination of the product.

Equipment in direct contact with food shall be suitable for food contact and meet legal requirements where applicable.
 

SQF

Section 11.1.7 - Equipment and Utensils

11.1.7.5: Benches, tables, conveyors, mixers, graders, and other mechanical processing equipment shall be hygienically designed and located for appropriate cleaning. Equipment surfaces shall be smooth, impervious, and free from cracks or crevices.
 

FSSC 22000

2.5.15 - Equipment Management

The organisation shall:

Have a documented purchase specification in place, which addresses hygienic design, applicable legal & customer requirements, & the intended use of the equipment, including product handled. The supplier shall provide evidence of meeting the purchase specification prior to installation.

Appendix 1 – Definition of Hygienic Design

Design and engineering (materials and fabrication) of equipment and premises that are easily cleanable assuring the food is safe and suitable for human consumption...

* Please Note: This is not an exhaustive list of hygienic design requirements in each standard.
 

Hygienic Design: Guidance, training, certification

In addition to the Regulatory and Standard requirements for hygienic design, there are also organisations that recommend best practices and provide guidance, training, and certification for the hygienic design of equipment and facilities. These include:

The European Hygienic Engineering & Design Group - a leading source of hygienic design and engineering expertise that enhances food safety and quality across the whole industry. EHEDG Guidelines Doc.8 on Hygienic Design Principles is free to download from the EHEDG website and available in many different languages. It describes the principles of hygienic design for equipment and factories intended for food manufacturing.

3-A Sanitary Standards, Inc. - a not-for-profit organisation dedicated to advancing food safety through hygienic equipment design through the collaboration of regulatory sanitarians, equipment fabricators, and processors. This is achieved through the development and provision of 3-A standards and guidelines, working groups, certifications, evaluations, training programs, and events.

Other important organisations offering popular standards, guidelines, training, and/or certifications related to hygienic design include:

Food Equipment Standards

Food Safety Equipment Design Principles

Bakery Equipment Assessment Group

 
Hygienic Design: Why is it important?

Equipment and premises of poor hygienic design are generally difficult to clean. Some examples of poorly designed and constructed facilities are shown below:

Narrow drains & poor flooring

Complex and difficult-to-reach areas at height

Poor floor-to-wall junctions

The problems illustrated above are very evident in legacy equipment and facilities, where they may raise the risk of cross-contamination and product adulteration.

The fundamental reason for applying hygienic design principles to facilities and equipment is to minimise the risk of food product contamination. Food production equipment and premises have been identified as sources of contamination, and The European Food Safety Authority (EFSA) recently published a review which concluded that  ‘Poor equipment hygienic design is the most crucial risk factor for persistent pathogens in food production’ (5).

 
Hygienic Design: Cleaning tools

Cleaning tools and utensils have also been found to be a significant source of contamination. One UK-Government funded study, conducted by Campden BRI, revealed cleaning equipment to be a major source of food pathogens.

The prevalence of Listeria monocytogenes in chilled food factory environments:

10,000 environmental swab samples -

• Production equipment = very low
• Floors = 17% positive
• Drains = 25% positive
• Cleaning equipment = 47% positive

Reference: Holah, J. T. (1998). Effective microbiological sampling of food processing environments. Campden & Chorleywood Food Research Association.

Here are some common examples of poorly designed cleaning tools and utensils:

Tools with poor design & surface finish

Site-made tools

Tools that are difficult & time consuming to clean

GFSI-benchmarked standards also require the use of hygienically designed cleaning tools:

BRCGS Global Standard for Food Safety

Section 11.6: Cleaning equipment shall be hygienically designed & fit for purpose.

Section 8.5.3: Equipment used for cleaning in high-care/risk areas shall be hygienically designed & fit for purpose.

FSSC 22000 Prerequisite programs on Food safety –Part 1: Food manufacturing

Section 2: Cleaning tools and equipment shall be of hygienic design...

Ultra Safe Technology explained

Vikan is a pioneer in the development of hygienically designed cleaning tools and utensils. These include our one-piece shovels and scoops, our Ultra Hygiene squeegees and handles, and our award-winning Ultra-Safe Technology (UST) brushes and brooms.

Our range of UST brushes offers a greatly improved hygienic design over traditional drilled and stapled brushes by eliminating the deep drill holes previously required to secure bristles. They also eliminate the need for metal staples and resins and reduce the risk of bristle loss.

• The first image is of a traditional drilled and stapled brush.  It shows where the contamination accumulates around and between the bristles. As you can see, when you clean a brush like this, the water and cleaning solution used can remove contamination at the brush’s surface, but it can’t get deep down inside the hole.
• For the second image of a resin-set brush, the same is true for the gap between the bristles where the resin hasn’t sealed. In fact, it is even more difficult to remove contamination from a narrow, deep crevice like this than it is from a relatively open drilled hole.
• The third image shows the UST brush. Here, the bristles are not stapled into a deep hole, but are moulded just below the surface. This allows for better removal of contamination by the wash water and, although not perfect, it means that UST brushes have a significantly improved hygienic design.

You can discover more about how to select hygienically designed, food-contact-compliant cleaning tools and utensils from the links provided here:

• Understanding bristle fixation in food industry brushware - Vikan
• Food Contact Approval EN (ipaper.io)
• Choosing hygienically designed cleaning and food handling tools (ipaper.io)

 
Future blogs in this series will offer further support related to the following equipment and facility sanitation challenges:

PART 3: Cross-Contamination Control Strategies: Plant Layout and Process Control

PART 4: Cross-Contamination Control Strategies: Managing Your Hygienic and Environmental Monitoring Zones

PART 5: Cross-Contamination Control Strategies: Creating Better Sanitation Programs

PART 6: Cross-Contamination Control Strategies: Dealing with the Pest Problem, Product Storage, and Transport Sanitation