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

Part 4 in this series defined the need for managing the hygienic zoning, environmental monitoring, and control programs required to ensure good factory hygiene and safe, high-quality food.  

This blog emphasises the importance of developing, implementing, and maintaining the risk-based sanitation control programs and procedures necessary to ensure the production of safe high-quality foods. 

As illustrated, sanitation programs often involve more than just the cleaning and sanitization/disinfection of equipment and other environmental surfaces. 

However, this blog will focus on the cleaning and sanitization/disinfection requirements of a sanitation program. 

Cleaning normally involves the physical removal of visible soils from surfaces, using appropriate cleaning methods and equipment, while sanitization/disinfection uses appropriate chemicals, heat, or radiation to reduce the microbial load to an acceptable level.  

Cleaning matters

The cleaning of equipment and environmental surfaces is a critical step in the management of food safety and quality.  

Cleaning removes most of the contamination and makes sanitization/disinfection more effective.  

Various regulatory authorities (FDA, FSIS, and EFSA) and global standards (BRCGS, SQF, and FSSC 22000)  mandate that food facilities must develop, implement, and maintain a risk-based cleaning and sanitisation /disinfection program:

	21 CFR 117.35(a) on sanitary operations require that “buildings, fixtures, and other physical facilities of the plant must be maintained in a clean and sanitary condition and must be kept in repair adequate to prevent food from becoming adulterated. Cleaning and sanitizing of utensils and equipment must be conducted in a manner that protects against allergen cross-contact and against contamination of food, food-contact surfaces, or food-packaging materials.” In FDA fiscal year 2023 alone, there were 289 site violations of 21 CFR 117.35(a).
	FSIS regulations make it clear that all food-contact surfaces (as stated in 9 CFR 416.4(a)), including those of utensils and equipment and non-food-contact surfaces (as stated in 9 CFR 416.4(b)) of facilities, equipment, and utensils used in the operation of the establishment must be cleaned and sanitized (as applicable) as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.
	According to an EFSA Journal article, one of the common risk factors for the persistence of pathogens in food and feed processing environments are “inadequate cleaning and disinfection” of environmental surfaces.
	BRCGS for Food Safety, Clause 4.11.2: states in part that: “Documented cleaning and disinfection procedures shall be in place and maintained for the building, plant and all equipment. Cleaning procedures for the processing equipment and food contact surfaces shall, at minimum, include - responsibility for cleaning; item/area to be cleaned; frequency of cleaning; method of cleaning, including dismantling of equipment, where required; cleaning chemicals and concentrations; cleaning materials to be used; cleaning records (including records for completion and sign-off) and responsibility for verification.”
	SQF Code for Food Manufacturing, Clause 11.2.5.1 on cleaning and sanitation states in part that: “The methods and responsibility for the effective cleaning of the food handling and processing equipment and environment and storage areas shall be documented and implemented.”
	ISO/TS 22002-1 prerequisite programs on food safety for food manufacturing, Section 11, provides cleaning and sanitizing requirements, including that for programs, cleaning and sanitizing agents and tools, cleaning in place (CIP) systems, and requirements for monitoring sanitation effectiveness.

Cleaning is usually not a one-size-fits-all activity, since several factors influence how, when, and why to remove soil from a surface.

Cleaning methods include:

• Automated cleaning: CIP or clean out-of-place without the use of tools
• Mechanical cleaning: in-place cleaning or out-of-place cleaning using manual or mechanically assisted tools
• Wet cleaning: involves the removal of soils using water and detergents
• Dry cleaning: involves the removal of soils by actions like wiping, sweeping, brushing, scraping, or vacuuming without the use of water and detergents 

Note: All cleaning methods have the potential to spread contamination. The key is to select the cleaning method that maximises contamination removal while minimising the risk of its spread.

The diagram above ranks some of the different cleaning methods in the order of their potential to generate and spread particles, droplets, and aerosols. Activities like vacuuming, wiping, scrapping and scrubbing rank lower on the scale than hosing and the use of compressed air.

However, even a low-risk sanitation action like wiping can become a high-risk one if the person doing the wiping isn’t properly trained, experienced, or conscientious.  

Don’t neglect the sanitation aids

Cleaning compounds, sanitization/disinfection agents, chemicals and other sanitation aids, such as tools, etc., used by a facility must be safe and effective under the conditions of use. They must be used, handled, and stored in a manner that will not adulterate food products or create unsanitary conditions.

Food sites must take effective precautions to ensure proper management of sanitation aids including:

• Use chemicals, such as detergents and sanitizers, that are approved by a credible authority in a food facility. Follow the manufacturer’s instructions and guidelines for safe and effective use.

• Employ cleaning tools and equipment that are fit-for-use, hygienically designed, and fabricated with safe and compliant materials that meet the applicable regulatory and standards requirements. Remember that the tools used to clean must also be cleaned, sanitized/disinfected, and regularly inspected and replaced, as appropriate. Consequently, cleaning tool management programs and procedures are essential to ensure proper tool maintenance over time.

• Educate and train employees so they can effectively and efficiently implement and maintain a site’s sanitation program. Employees need to be conversant with the key parameters necessary for the removal of soils from a surface, as illustrated:

Continuously improve the sanitation culture

Here are some tips for improving sanitation culture in your facility:

(a)

• Create and maintain a documented and implementable Sanitation Standard Operating Procedures (SSOP) for each piece of equipment, area, item, or combination thereof. This is key in establishing the baseline for the sanitation activities necessary. Typically, an SSOP would have the following key sections defined:
• Purpose and scope
• Responsible people and departments
• Step-by-step procedural tasks
• Monitoring actions
• Corrective actions
• Verification actions
• References and revisions
  
  

(b)

• Develop and implement a documented Master Sanitation Schedule (MSS), that includes provisions for the effective cleaning of equipment, clothing, facilities, tools and utensils, amenities, and external areas. Records should provide adequate proof that the activities have been completed and reviewed by the people(s) responsible. Illustrated here is an example of MSS showing the key elements. These may vary from site to site:

(c)

• Aim for an effective and implementable sanitation program that is validated (by those designing and planning the program), monitored (by employees and supervisors in real-time), and verified (usually through use of an established test method and/or periodic review of results [trend analysis]). This is usually a regulatory and food safety standards requirement, which reflect the Codex Alimentarius requirements shown below:

 
*Source: Codex Alimentarius Commission. 2008. Guidelines for the validation of food safety control measures, CAC/GL69-2008. Geneva, Switzerland 

Summary

It is important to reiterate that sanitation programs are just one of the essential pieces of the holistic hygiene puzzle. There are many things to consider when it comes to creating better, more integrated sanitation programs for a site.

White papers available on our website that could help support the development of your food site's sanitation program are linked below:

• The Role of Manual Cleaning in Biofilm Removal (ipaper.io)
• Dry_Sanitation_Solutions_UK (ipaper.io)
• Cleaning-Tool-Maintenance-WhitePaper-EN-300 (ipaper.io)
• Food Contact Approval EN (ipaper.io)

The last blog in this series will offer further support related to the following equipment and facility sanitation challenges:

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