From allergen mapping to choosing the right tests for your site, it's time to revisit the key stages of Allergen Cleaning Validation.

Allergen Cleaning Validation is the process of confirming that the cleaning procedures at your site are sufficient to remove allergens or reduce them to an acceptable level.

This process is critical to food safety and audit compliance, with Clause 5.3.8 of the BRCGS Global Food Safety Standard stating that a site’s cleaning methods must be “validated to ensure they are effective and the effectiveness of the procedure routinely verified.”

To provide support, we have created a guide to Allergen Cleaning Validation, covering the areas listed below. There is valuable information in each section, but you can use the links to jump ahead.

Allergen Mapping

Creating an Allergen Risk Matrix

Conducting an Allergen Risk Assessment

Identifying the Worst-Case Scenario

Choosing the Right Allergen Tests

Verifying your Cleaning Processes

Taking Corrective Action

Root Cause Analysis and Corrective Action

Allergen Cleaning Validation: Preparation

Allergen Mapping

First, you need to identify the location of all the allergens at your site and how they move through the production process. Along with a detailed document, a colour-coded map of your factory could also prove incredibly helpful.

As you build an allergen profile for each of your ingredients and the allergens they contain, it’s vital that you include details of where the raw materials were produced. You should be able to track your ingredients back through every step of the supply chain, monitoring the contamination risks at every stage. You should also be aware of the control measures carried out by your suppliers.

Allergen Risk Matrix

Next, you should build an Allergen Risk Matrix – assessing and ranking the different allergens at your site. Here, you will need to consider the contamination risks posed by the method of production and the form of the allergen. For example, you may reason that a powdered allergen that will be agitated during production is more of a risk than a solid allergen that is easier to control.

Allergen Risk Assessment

Clause 3.5.1.1 of the BRCGS Global Food Safety Standard, Issue 9 asks that food production sites undertake “a documented risk assessment of each raw material or group of raw materials” taking into account “the potential for allergens (allergen content and potential contamination”.

To complete this assessment, you will need to identify the areas of your site and, more specifically, the parts of your production process where there is a risk of allergens getting to where they shouldn’t be. If you recognise that cleaning is a control measure that eliminates these risks or reduces them to an acceptable level, you will need to carry out an Allergen Cleaning Validation.

Allergen Cleaning Validation: Testing

Identifying the Worst-Case Scenario

Before you carry out the validation process, you first need to identify the worst-case scenario. This will help you to decide which allergen you are going to test for and which samples you are going to collect. You will need to answer the following questions:

  • Which allergen is the hardest to remove? (the most stubborn residue)
  • Which product has the highest levels of the relevant allergen?
  • Which product has undergone processes that will make the allergen hardest to detect?
  • Which surface areas are most likely to be missed during a clean?
  • Which surface areas are going to be left for the longest period before cleaning?

By testing for the worst-case scenario, you can not only prove the effectiveness of your cleans when removing the most challenging allergen under the hardest conditions, you can also – by extension – prove the effectiveness of these processes when tackling less-challenging scenarios.

If you approached your validation the other way around, focusing instead on the easiest allergen to remove, it is likely that your auditors and customers would require further evidence.

Choosing the Right Allergen Tests

When selecting the right allergen tests for your Allergen Cleaning Validation, you will need to consider a wide range of factors. Key examples include:

  • Whether the tests have been designed with the relevant allergen in mind.
  • Whether the tests become less accurate when specific processes have been carried out.
  • Whether the tests are likely to be compromised by the cleaning materials used at your site.

Quantitative Allergen Tests

Typically, sites will use quantitative methods such as ELISA tests for the validation of their cleaning processes, sending samples away to external laboratories or using their own on-site laboratories to determine the specific levels of an allergen. This information helps factories to establish benchmarks for effective cleans. In the case of a failed test, it also helps sites to find out how close they were to achieving an acceptable clean. As a general rule, these tests will be carried out at least three times.

In order for your testing to be sufficient, you will need to secure the correct samples. First, you need to test the source of the allergen contamination (e.g. a product with high levels of the allergen). This is your opportunity to prove the tests you are using are capable of detecting the allergen. You may also want to test surface areas or rinse water samples before cleaning.

Next, you should test the same surface areas or rinse water samples after cleaning. These areas or rinse water samples should have come into contact with the allergen (before cleaning) and should be intended for contact with products that don’t contain the allergen.

Finally, you need to test a sample of the products that have come into contact with the post-clean surface area or rinse water. The results of these tests will help you to find out if the allergen has contaminated the allergen-free product or if the risk has been effectively managed. Often, sites will test samples from the first, middle, and last product to pass through the line.

Qualitative Allergen Tests

During the validation of your cleaning processes, it is recommended to carry out a Lateral Flow Immunoassay (LFI) alongside your quantitative tests, proving a correlation between the two methods. This is vital if you plan to use LFIs for the ongoing verification of your cleaning – saving time and money, and allowing you to carry out the verification process on site. LFIs are a qualitative testing method, revealing whether or not an allergen is present, but not the specific levels.

When selecting your LFIs, assay time and cost-effectiveness should be key considerations. You should also think about how easy it will be to both store and use your tests. At Klipspringer, we have launched a range of Rapid Allergen Testing Kits with these factors in mind.

We have also ensured that when using our EASY Allergen range, your samples remain viable for further testing. So, in the case of a failed test, you will be able to send off the relevant sample or take it directly to your on-site laboratory (if applicable) – saving time and reducing costs.

Detection of Organic Residue

Neither traditional ATP tests nor the more advanced A3 system can be used to detect specific allergens. However, the A3 system could be used to support the ongoing verification of cleaning processes at your site. This is because it detects all forms of organic residue: ATP + AMP + ADP. Generating results in a matter of seconds, it provides a quick and cost-effective way to find out how much organic residue remains on a surface or in a rinse water sample.

If a sample passes an A3 test, you can assume it is also highly likely to pass an allergen-specific test, as if the levels of organic residue are extremely low, it follows that the same will be true of allergenic residue. You can then carry out your allergen test with greater confidence in a pass result, reducing the risk of a wasted LFI.

View our Rapid Allergen Test Kits
Learn more about the A3 System

Root Cause Analysis & Corrective Action

Clause 4.11.3, Version 9 of the BRCGS Global Food Safety Standard asks that “limits of acceptable and unacceptable cleaning performance shall be defined for food contact surfaces and processing equipment. The site shall define the corrective action to be taken when monitored results are outside of the acceptable limits.”

When deciding on the appropriate course of corrective action, we recommend that you start the process with a Root Cause Analysis. You can click here to view our guide to this step, outlining three of the most popular methods. Root Cause Analysis will help you to work out exactly why your cleaning process failed and which stages of the clean need to be targeted.

Once you have made the necessary changes, you will need to repeat the validation process. However, you may want to carry out LFI or A3 tests first – using these more cost and time-effective methods to predict how likely it is that your cleaning procedure will pass the next round of validation.

3 Methods for Conducting a Root Cause Analysis

So there you have it, an overview of Allergen Cleaning Validation at food production sites.

If you require any further guidance, we would be happy to help. Our in-house team of experts will provide support and relevant resources.

You can also contact us on 01473 461800 or sales@klipspringer.com. Alternatively, you can use the form below to arrange a conversation. 

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