Allergen Eradication Cleaning & Validation

September 9, 2022

Table of Contents

What are Food Allergies?

Allergies are caused by an adverse immune reaction to certain food proteins. While food allergies may affect a small proportion of the population, an allergic reaction can be severe or potentially fatal.  Allergies are classified according to their immune mechanism:

1. Immediate (immunoglobulin E (IgE)-mediated, symptoms typically develop within minutes to one to two hours of ingesting the food.

2. Delayed hypersensitivity (non-IgE mediated, cell-mediated)

3. Mixed IgE and non-IgE mediated.

Mixed IgE and Non-IgE-mediated food allergies present with their symptoms several hours after the ingestion of the food.  A variety of proteins and eight foods/food groups (and derived products) are implicated.

 Food ingredients that must be declared as allergens:
Cereals containing glutenSoybeans, andTree nuts
CrustaceansPeanutCelery
EggsMilkMustard
FishMolluscsSesame seeds
Sulphur dioxide and sulphitesLupin

Allergen Management

Allergen management practices should be part of any effective hygiene practice (GHP) and HACCP system. Food business operators (FBO) must take steps to accurately declare the presence of allergenic ingredients, minimise the risk from, and, where possible, prevent unintended allergen presence. Undeclared allergens are life-threatening contaminants and incomplete validation data, or inaccurate data can put lives at risk.

Factors Contributing to Exposure

However, treatments lethal for pathogenic microorganisms, such as heating, high pressure processing, etc. generally do not destroy allergenic proteins as the responsible protein may survive intact without having undergone any chemical transformation.

Processes that degrade proteins, such as enzymatic hydrolysis, should not be relied upon to eliminate or destroy allergenic proteins.

Allergen Cleaning Validation Programme

Allergens are very resistant to heat, proteolysis, and pH, with trace amounts initiating an allergic response.  As with any type of cleaning validation the same variables must be considered when validating for allergen cleaning, these being:

  1. Soil Type
  2. Surface Texture 
  3. Cleaning Method

Soil Type

A different method is needed for the removal of liquid egg residue versus that for the removal of powdered egg e.g., peanut and tree nut protein have a high oil content, which will require a detergent to remove the soil from the surface of the equipment, container, or utensil. In addition, the dusty nature of an ingredient, such as flour, will allow for airborne dispersal and require different handling, cleaning, and containment procedures.

Showing Different Foods Requiring A Different Method of Allergen Cleaning. ie Flour, Liquid & Powdered Egg.

Surface Texture

Processing equipment found in food manufacturing facilities is primarily of stainless steel. Surface roughness is influential both in terms of allergen entrapment, cleaning protocols required and verification techniques to ensure complete allergen removal. There may be instances where the stainless steel is not smooth, such as areas with rough welds, die-cut rollers, or mesh belts. Other types of surfaces commonly found in food plants include several types of plastic (polyethylene, UHMW, polycarbonate, PVC, vinyl), rubber, glass, wood, and cloth.   Absorbency and smoothness are two characteristics of surfaces that will influence the removal of residues (allergen or otherwise).

Different Textures Found in Food Processing Industries Requiring A Different Method of Allergen Cleaning. ie Stainless Steel, Mesh Wood and Glass.

Allergen Cleaning Methodology

There are three categories of cleaning for allergen removal: 

1. Dry Cleaning

As the name suggests does not involve water or chemical solutions but physical methods, brushing, wiping, scraping, or vacuuming to physically remove dust depending on the equipment to be cleaned. In certain instances, powdered crystalline detergents are spread on floors and areas from which dust and extraneous soil are swept. In a dry ingredients production facility, where water is prohibited, allergens may be managed by low-pressure spraying of the surface with a suitable solution for a given duration and then wiped down and dried. 

2. Wet Cleaning

The traditionally understood form of cleaning involves water and chemicals (alkaline or acid cleaning compounds). Wet cleaning particularly foam cleaning, but not high-pressure cleaning (<40 bar) for allergen control is highly effective. In the case of COP (Cleaning-out-of-place) where sensitive equipment or the physical design prohibits CIP, equipment must be dismantled, and individual parts washed down and dried before reassembly. It must be understood that sanitisers do not remove residues, including allergenic proteins. 

3. Cleaning-in-Place

CIP is the default system in the food processing sector however in relation to allergen control a number of measures require implementation to prevent contamination, these being:

Single-use wash water to prevent contamination carry over
Monitoring of cleaning efficacy
Dedicated equipment
Post-allergen run washing
Correct chemical concentrations
Vessel inspection, absence of ponding
Run a product (wet or dry) through a line to purge any residues

Allergen Removal

Recommendations for cleaning contact surfaces focus on preventing microorganisms, such as bacteria and viruses, from contaminating foods, however, these recommendations are insufficient for preventing the transfer of food allergens.  Allergen removal is influenced by the nature of the allergenic food matrix, allergen load on a surface, surface composition and integrity, and the type of cleaning utensils.

Several observations are worth noting:

Wet cloths or wipes are more effective for allergen removal from surfaces than dry wipes.
Scraping food from surfaces prior to full cleaning assists removal of allergens.
Storage of cloths in a sanitiser solution reduces allergen transfer between surfaces.
Allergens are difficult to remove from textured plastic surfaces.

Controlling Allergens

PPE for Controlling Allergens in Food Industry

The three fundamental control strategies for food allergens are:

  1. Dedication
  2. Separation
  3. Labelling

A comprehensive allergen prevention plan involves allergen mapping, ingredient control, system design, traffic patterns, work in process, maintenance, packaging and labelling, scheduling, effective cleaning and training.

Allergen MappingSource of allergens in the plant and their introduction to the process. The addition of allergens as late in the process as possible reduces the potential for cross-contamination.
Ingredient ControlDetailed information from suppliers to ensure that allergens are properly identified.
System DesignEquivalent sanitary design principles applying to microbiological control apply to that for allergens. Equipment is designed for ease of cleaning with access for cleanouts and inspection. 
Traffic PatternsEliminates conflicts within the production line.
Work in Process and ReworkThe working process and rework must be clearly labelled implying colour coded containers or labels. A periodic audit of rework practises is advisable.
MaintenancePreventative maintenance of all equipment.
Packaging and Labelling
SchedulingDedicated production systems and extended production runs.

Cleaning Validation

Visually inspect all dismantled and cleaned equipment for visual residues. Assess what it takes to achieve an allergen free system. Once visual cleaning can be achieved on a reliable basis using these SSOPs (Standard Sanitation Operating Procedures), allergen specific tests, which Biocel would be happy to conduct, provide additional validation to demonstrate that allergenic proteins are removed. Employees must be properly trained in food safety, including food allergy awareness.

The potential for cross contamination of multiple filling lines within the one facility is self-evident and adds a new level of complexity, requiring effective and proven cleaning and sanitation procedures to ensure food contact surfaces are clean and free from contamination.

Sanitation Standard Operating Procedures

Diligent application of cleaning and sanitation principles is increasingly important. 

A Typical SSOP Will Include:
Description of the equipment and zone to be cleaned.
Implementation of a lock-out tag-out (LOTO) procedure.
Necessary PPE
A list of hand tools and cleaning chemicals and equipment required.
A comprehensive procedure for disassembly and preparing the equipment, and surfaces to be cleaned.
Cleaning and washing instructions.
Quality and preoperational checks.
Assembly and final disinfection. 

Allergen Eradication Cleaning Products

Biocel has a number of products in its portfolio designed to degrade food allergen proteins and inhibit allergenic properties with an acceptable safety profile. Not all cleaning chemicals do this, sanitisers may not fragment food allergen proteins sufficiently to render them ineffectual, particularly if in the presence of organic material. Indeed, the correct concentration is required to rapidly break down the protein in the time available.

For a comprehensive service examining your allergen eradication cleaning needs contact Biocel and let us demonstrate how our chemicals can enrich your process.

Some of our Market Leading CLEANING PRODUCTS for food processing plants

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