The Hygiene Hustle is back! Returning for a second episode, this exciting new podcast is brought to you by Phil May, in association with Klipspringer.  

As Group Hygiene Manager for Greencore, Phil will be drawing on his twenty years of experience to address the topic of Validated Cleans, guiding you through key processes such as establishing pass limits, reviewing your Cleaning Instruction Cards, and creating your Validation Reports. 

There are valuable takeaways throughout the podcast, but you can use the links below to skip straight to the section most relevant to your needs.

You can also watch the full podcast below:


What is a Validated Clean?

In this context, validation is the quantitative assessment of cleaning methods. It is the process of ensuring these methods are sufficient to minimise food safety and cross contamination risks to an acceptable level. Put simply, validation is the way in which you check whether the cleans at your site are 100% effective when it comes to the removal of allergens and bacteria.

It is impossible to overstate the importance of validation within a food or beverage production site. After all, getting this process wrong could result in serious illness or even fatality for the consumers exposed to your product.

What needs to happen before a Validated Clean takes place?

Consider Cleanability

Before doing anything else, you need to answer a series of questions about the equipment being cleaned at your site.

  • Is it fit for purpose?
  • Is it used for multiple applications or just one?
  • Is it hygienically designed and easy to clean – free from trap points and harbourages?
  • Is there a Cleaning Instruction Card (CIC) in place?

Hazard Analysis

The next step is to carry out a Hazard Analysis. First, take a look at the design of the equipment you are planning to clean. You need to identify any areas where dirt and debris are likely to build, then work out the best approach to tackling these parts. If they are hard-to-reach, it is likely that you will require specialist cleaning equipment.

Other hazards relate to the concentration of the cleaning chemicals being used, the temperature of any water involved in the process, and safety concerns surrounding the dismantling of your equipment. It is vital that you identify these hazards early on and factor them into your validation.

Establish Pass Limits

The next step is to decide what constitutes a pass and what constitutes a fail when it comes to validating the cleans at your factory. This will vary from site to site.

For instance, if you are a low risk factory with no allergen risk, it may be as simple as validating to no visible debris. Alternatively, if you are in a high care factory with no allergen risk, you may decide to validate to no visible debris, plus a level of bacteria that sits within a set limit. Finally, if your site handles allergens, you will have to validate against the removal of the allergens in question, with even trace amounts capable of cross-contaminating your product.

Prepare for the Worst-Case Scenario

The analytical tests you choose for your Validation Process need to be specific, sensitive, representative, and reproducible. Direct methods include swabbing for bacteria, swabbing for ATP, and using the A3 system to swab for adenosine molecules in all three forms. In terms of allergen testing, there are also rapid lateral flow tests and ELISA tests. An example of an indirect testing method includes testing the rinse water in a Clean-in-place (CIP) system.

When selecting the best analytical testing method for your site, you will need to consider the worst-case scenario, answering the following questions:

  • What is the worst-case scenario for soiling? e.g. the strongest adhering soil, the highest level of allergen, or the hardest soil to remove
  • How could the processes taking place at your site impact the soil? e.g. heating or freezing
  • Which soil sits for the longest before the hygiene team arrives to remove it?
  • What is the best way to simulate the worst-case scenario?

In terms of the final question, Phil has often made use of fault mixes – combining allergens to create a substance that can then be applied to the surface being tested. This surface will be tested before the clean, once the fault mix has been added, and for a final time after the clean has been completed. This will speed up the validation process, as you will be able to test your ability to clean all possible allergens in one go. Just remember to factor in the possibility of the allergens interacting with one another to produce unexpected results.

Review the Cleaning Procedure

Finally, you will need to review the Cleaning Instruction Cards and specific cleaning procedures at your site. Phil discussed the process of writing your CICs in Episode One of the Hygiene Hustle, highlighting them as a brilliant means of ensuring everyone at your factory knows how to clean equipment to the right level. Your CICs will include all of the expected information, such as the details of any strip downs, key inspection points, and cleaning chemicals.

However, a lot of sites fall short when it comes to documenting the specifics. For example, most chemical suppliers provide a recommended band for chemical concentration e.g. 3-5% and this will often be included on a CIC. However, this percentage band allows for variations across different sites, accounting for varying levels of water hardness. Consequently, your CIC should be factor in the specific water hardness at your site. This will be particularly important when you are working out the worst-case scenario.

Step One of the Validation Process

The first step is to create your Validation Protocol – the document that explains what you are going to do and how you are going to do it. This could be in reference to the cleaning of a specific piece of equipment, or it could be a more general document about how you are going to validate the cleaning of equipment in an area of your site e.g. a high care, low care, or low risk zone. This may be the case if you plan to use the same approach for each piece of equipment.

Your Validation Protocol Document will need to include:

  • The aim of the validation process
  • What is being validated against
  • Who is responsible for the validation process
  • The CIC and a step-by-step of the process being carried out
  • Details of the test methods being used
  • Details of the test points for each piece of machinery
  • The pass/fail limits for each test

Step Two of the Validation Process

The next step is to carry out at least three cleaning trials across your site to check that the protocol in place is working. These trials need to be spread across different cleaning teams, carried out at different times of day, and should factor in seasonal variations.

The trials will also need to reflect any changes to your site, updated on a regular basis. From small alterations such as the introduction of a new cleaning chemical or the relocation of a piece of equipment to larger changes such as the replacement of your hot water system or even a full factory redesign, an updated cleaning trial will be essential.

Step Three of the Validation Process

Validation forms a key part of every major audit, so It’s important that you keep a detailed record of your validation trials. Your Validation Reports should contain:

  • A summary of the objective(s) behind your validation
  • A detailed breakdown of the results
  • Any deviations from what was agreed in your protocol
  • Any general conclusions – good and bad
  • Any points that will inform your approach to verification and monitoring moving forward

Step Four of the Validation Process

In this context, verification is the periodic assessment of cleaning methods to ensure the validated methods are still working. Put simply, it is the process of making sure everyone at your site is doing what they said they would do and that whatever is being done is still working.

This can be achieved through methods such as rapid swabs, ATP swabs, A3 swabs, hygiene auditing, and hygiene operative observations. Verification plays an important role in the Validation Process, as it is the only way to ensure the standards at your site are consistent and in keeping with the latest audit expectations.

What should you do if your results are unexpected?

Unexpected and unsatisfactory results can occur for a number of reasons:

  • Poorly trained operatives who don’t know how to carry out an effective clean
  • Poorly trained operatives who don’t know how to carry out the validation process
  • Something new has been introduced to the factory environment
  • A change in water temperature (water systems in factories can often be unreliable)
  • Interaction between different allergens, making them harder to remove
  • Chemical concentration e.g. dosing systems that are driven by water pressure will be impacted by any changes to the pressure

The most important thing is how you respond to unexpected or unsatisfactory results. First, you will need to go back and check all the steps of your validation process. You need to make sure you aren’t missing any of the key factors that need to be controlled.

If you are still struggling, don’t be afraid to engage with a specialist. Your chemical supplier or the provider of your equipment may be able to offer an alternate approach to either your cleaning or validation process.

The Hygiene Hustle is available on Podbean. Klipspringer will also be hosting each episode and we will be providing updates with every new release. If you would like to catch up on Episode One, simply click the button below.

For more Hygiene Hustle content, you can find Phil on Instagram @hygienehustlepod and email him at: Phil is also happy to answer any questions and take topic requests for future episodes.