What Is Cleaning Validation?

A large hospital room is filled with four hospital gurneys, with blue and white bedding, a red foldable chair to the left of each bed, a wooden side table and red privacy curtains in between each bed.
What Is Cleaning Validation

Credit: Adhy Savala

If you manage spaces that see heavy foot traffic, manufacture medical treatment products, or make products for consumption, then you need to know about cleaning validation. Cleaning validation is an essential part of successful sanitization regimens, safeguarding where large groups of people can be put at risk from harmful contamination.

Cleaning validation is a process of ensuring that the cleaning process is effective. It requires a careful balance of identifying contamination risks and costly cleaning resources to determine an appropriate cleaning strategy.

This article delves into the contexts where cleaning validation is often necessary, alongside exploring some of the methods to ensure that your sanitization job is thorough. Cleaning validation can tell you both where cleaning processes need to be improved as well as whether staff need additional training.

What Industries Use Cleaning Validation?

As a result of the COVID-19 pandemic, people have become acutely aware of the importance of thoroughly cleaning contact surfaces. Although some types of residue on surfaces are apparent, microorganisms are invisible to the naked eye.

For this reason, many technologies have emerged to assess the sanitation of surfaces. An organization’s need for cleaning validation solutions varies by industry. Let’s go through a few of them.



Building Service Contractor Cleaning Validation

Janitorial companies and environmental managers need to be especially vigilant in their cleaning and disinfection practices to ensure quality that not only reflects their brand, but also complies with industry standards. With cleaning services, competition is fierce, and reputation is everything. You can’t afford to have an outbreak as the result of insufficient disinfection on your watch.

Cleaning validation processes warrant that your practices effectively clean and disinfect all surfaces. Different contexts will require different validation strategies, so preparation for all of them is key to ensuring you can service any client, regardless of industry or location.

Cleaning Validation in Education

Educational institutions from elementary schools to universities see large groups of people circulating through buildings and spending prolonged periods in contact with desks, chairs, and a variety of other surfaces. Needless to say, surface-borne contamination can spread quite quickly if high-touch surfaces in high-traffic areas aren’t properly cleaned.

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Generally speaking, the younger the students, the messier and less germ-conscious you can expect them to be. When you get down to elementary and preschool, daily (or more) disinfection and routine cleaning validation of surfaces are a must to prevent the spread of germs. Many states and school districts have enacted their own regulations regarding the cleaning of educational facilities, especially since the onset of the COVID-19 pandemic.

Cleaning Validation for Medical Devices

Perhaps the most critical industry for cleaning validation is in healthcare, particularly with medical devices. Medical devices are in close contact with patients, often for prolonged periods. Catalyzed by sweat and multiple other bodily fluids, this provides a ripe opportunity for bacteria and viruses to breed and spread.

When it comes to medical devices, cleaning validation is not only needed prior to reuse, it is also required along the manufacturing line prior to distribution to ensure contamination of delivered goods does not happen. Medical devices, but also the equipment that produces them, must be routinely cleaned and assessed for contamination.  

Currently, no standardized FDA cleaning validation protocol exists. However, the FDA does require cleaning validation policies to exist in facilities. Although there are general standards for cleaning validation procedures for medical devices across the healthcare industry, they are not regulated. Despite a lack of regulation, medical device manufacturers and care providers are still responsible for a lack of attention to industry standards should their negligence result in an illness.

Cleaning Validation in the Pharmaceutical Industry

Cleaning validation in pharma, particularly in manufacturing, is bound by the same imprecise regulations as the healthcare industry relative to medical devices. In the pharmaceutical industry, not only are there pathogens to monitor but potentially hazardous chemical byproducts as well.

With regular use, machines used to manufacture pharmaceuticals can build up chemical residues. If these chemicals find their way back into the production line, it could result in toxic contamination or inaccurate dosages, leading to an expensive and time-consuming product recall and possible harm to the consumer.

Cleaning Validation in the Pharmaceutical Industry

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Cleaning validation strategies in the pharmaceutical industry largely focus on monitoring the cleanliness of manufacturing equipment. Data gathered from cleaning validation can then be used to determine best practices for sanitizing sometimes difficult-to-clean equipment.

Cleaning Validation in Other Industries

Other industries, such as entertainment, manufacturing, real estate, and retail, all experience high foot traffic. If not cleaned properly and frequently, a venue, factory, open house, or store can easily become a vector for illness.
Spaces such as these require daily cleaning to ensure that they do not become breeding grounds for pathogens. Cleaning validation allows you to detect areas where cleaning processes can be improved.

How Many Types of Cleaning Validation Are There?

There are numerous means of validating the cleanliness of a surface, each suited to a particular context. In general, cleaning validation involves testing a representative sample surface to determine its cleanliness which stands as an estimate for the overall cleaning job. There are two types of sampling and three criteria by which the cleanliness of these samples can be analyzed.

Types of Sampling

The two types of sampling for cleaning validation are direct and indirect. The direct method involves assessing the cleanliness of the surface or object itself. The indirect method assesses a third substance, usually a liquid, that has been in contact with the surface being tested.

1. Direct Sampling

The direct method of cleaning validation is the most intuitive. It involves using some means of directly observing contamination on the surface being tested. The most rudimentary direct method would be a visual inspection, though in most contexts this is far from sufficient and reliable.

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Other methods involve applying a chemical marker that reacts with contaminants and is displayed with proprietary imaging technology. Optisolve’s Pathfinder™ is an example of this method.

Pathfinder™ uses a chemical spray that reacts with DNA on surfaces. When it reacts with this compound under UV light cameras, it sends a signal which be picked up and processed by our special SAVI software system. This allows you to see photographic proof of where biological contaminants remain after cleaning.

Another method is ATP metering in which surfaces are swabbed with a substance that reacts with Adenosine Triphosphate (ATP). ATP is a molecule that is responsible for energy production in cells. The chemical reacts with ATP and glows using the same process that gives fireflies their light. But whereas Pathfinder™ gives you a 10×10 square inch visual representation of the contamination, an ATP meter only tells you how much contamination exists within a 4×4 square inch given area using a numerical sc2le.

2. Indirect Sampling

With indirect sampling, a surface or object to be tested is rinsed with a solvent, and then the solvent is tested for contaminants. A commonly used solvent for this method is water. Due to the fact that water is pH neutral, it can be used to detect the presence of acidic or alkaline substances.

The difficulty with this method is that it is only as good as a solvent’s ability to dissolve contaminants. A solid residue that does not rinse off with the solvent will not be detected in a sample with this method.

Acceptance Criteria

There are generally three types of acceptance criteria for cleaning validation: physical, chemical, and microbial. Each of these will have their own inspection methods.

The physical criterion is the most basic. This could involve something as simple as a visual inspection for residue or particulate matter. This may involve magnification equipment.

The chemical criterion usually involves some sort of reactant agent. The byproduct of the reaction between the reactant and contaminant is used to estimate the level of contamination of a surface. This may be done with color-changing dyes or other chemical indicators.

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Lastly, the microbial criterion also involves a reactant but one specifically designed to detect the byproducts of biological processes. This may involve detecting certain proteins with a chemical indicator.

Cleaning Verification vs. Validation

To this point, we have largely glossed over the distinction between cleaning validation and cleaning verification. Though their purpose is the same–to determine the cleanliness of a surface–the processes used and frequencies differ.

The purpose of cleaning validation is to ensure that your cleaning processes are effective at the outset. Thus, cleaning validation should be carried out any time new equipment or facilities are brought into commission or changed. Cleaning validation is usually more thorough and will often involve more than one testing method.

Cleaning verification on the other hand is used to ensure that cleaning procedures were adequately performed. This will use insights from the cleaning validation process to test for the most common forms of contamination for a surface’s given use case.

SOP for Cleaning Validation

Cleaning validation can be a time-consuming process that involves several stakeholders and testing procedures. Central to cleaning validation is an organization’s standard operating procedures or SOP for cleaning validation.

The SOP lays out how the cleaning validation is to be carried out, who is responsible for what, and the criteria used to determine the adequacy of cleaning procedures. While SOPs will vary greatly from industry to industry, there are a few basic elements that are common to all cleaning validation SOPs.

First, the SOP will lay out the scope of the cleaning validation process. This details what surfaces are subject to the procedures listed in the SOP, and where hot spots might occur.

SOP for Cleaning Validation

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Next, the SOP should delegate responsibility for the cleaning and validation procedures detailed within. This should include both who is responsible for carrying out procedures as well as who is responsible for signing off on them.

An SOP must also lay out references to accepted cleaning criteria as well as any abbreviations or definitions to be used. This makes it for others to clarify the meaning of certain procedures.

The SOP should lay out cleaning validation protocols. Investigation into the cleanliness of your facilities and equipment should yield worst-case surfaces where contaminants concentrate the most. These create grounds for your testing procedures. The SOP should detail worst-case sites, the contamination risks, and the means for testing them.

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A helpful tool for assessing worst-case sites during a cleaning validation risk assessment for testing is a cleaning validation matrix. This lays out the types of contaminants and the surfaces where they build up the most for testing. The cleaning validation matrix gives you a visual representation of your worst-case sites allowing you to take the fewest samples during cleaning verification while still producing effective results.

The SOP should then detail the appropriate method for addressing contamination. This will be based on testing cleaning procedures using the cleaning validation protocols for the highest-risk sites to establish optimal and acceptable processes.

Lastly, the SOP should provide sample forms or software instructions for carrying out the cleaning validation.

Cleaning Validation Software

Currently, the majority of cleaning validation software available is designed for large-scale pharmaceutical outfits. The market for cleaning validation software that tailors to high-foot traffic industries is lacking. 

The facility maintenance and cleaning industry needs a software system that allows them to track and report on their processes. That’s where Optisolve comes in. SAVI® allows all cleaning and facility maintenance departments in a wide array of industries to standardize, monitor, and measure facility performance to determine areas for improvement. 

Not only does Optisolve have the organizational software system to achieve all of this we also have an award-winning surface testing methodology that allows you to identify surface contamination using validated image proof all in real-time. 
To get started with Pathfinder™ and SAVI®contact Optisolve today!