Written by Paige Daley, Associate Marketing Manager for Optisolve
Cleaning verification vs validation are two closely related but different cleaning procedures – both of which can lead to serious consequences if not followed correctly.
While these two processes are closely related, they are distinct in their objectives and methods. Failure to properly implement either process can have serious consequences, such as legal action, loss of clients, and reputational damage.
Consider a scenario in which an outbreak of a contagious illness occurs in a commercial office building, and elevated levels of harmful bacteria or viruses are detected. Upon investigation, it is discovered that inadequate cleaning and sanitation procedures were the root cause of the contamination. This situation highlights the importance of following proper cleaning validation protocols in the building services sector to ensure a safe and healthy environment.
As a result, inadequate cleaning and sanitation procedures in commercial office buildings can result in serious consequences, such as legal action, loss of clients, and reputational damage for cleaning services providers or building management. Therefore, it is essential to implement proper cleaning validation protocols in the building services sector to prevent these risks and ensure a safe and healthy environment.
Understanding Cleaning Validation and Verification
Cleaning verification and cleaning validation are critical processes for maintaining a clean and hygienic environment, and are often used interchangeably. However, there are distinct differences between the two, and it’s important to understand the distinction to ensure that your facility is properly cleaned and disinfected.
On one hand, cleaning verification is the process of confirming that a cleaning procedure has been performed correctly. This involves testing equipment and surface areas to ensure residue limits fall within acceptable limits and that all meet predetermined cleanliness standards.
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On the other hand, cleaning validation is the process of proving that a cleaning procedure is effective in removing all traces of contaminants from a surface or equipment. This involves a more rigorous testing process, including a risk assessment and a detailed cleaning validation plan.
Cleaning Validation is typically performed less frequently than cleaning verification, such as once a month or once a quarter, depending on the industry. Validation is critical in ensuring that high-risk areas, such as operating rooms, cleanrooms, dining halls, and classrooms are properly cleaned and disinfected.
For example, cleaning verification is often used to ensure that high-touch surfaces, such as doorknobs and light switches, are properly cleaned and disinfected on a regular basis. Cleaning verification can also be used to ensure that cleaning validation guidelines are being followed consistently, even in areas that may not be considered high-risk.
Whereas, cleaning validation may be used in more critical areas, such as operating rooms or cleanrooms, to ensure that all contaminants have been removed from the surfaces and equipment.
Validation is also required in industries such as pharmaceutical manufacturing or food processing, where the risk of contamination and microbial growth is high and the consequences of failure can be severe.
Cleaning Verification & Validation Methodology Differences
To quickly recap, cleaning verification is the process of ensuring that a cleaning procedure was performed correctly, often done via visual inspections and surface testing. Whereas, cleaning validation requires a more in-depth analysis of the cleaning procedure and tests that verify the cleaning process meet acceptance criteria.
|Cleaning Verification Methodology and Occurrence|
|Swabs||Cleaning validation swabs are used to collect samples from surfaces for testing. The swabs may be moistened with a sterile buffer solution to make residue easily removable with manual cleaning.|
|Test Strips||Small pieces of paper or plastic that have been coated with a chemical indicator. When the strip is moistened with a liquid, the indicator color changes to indicate the presence of a particular substance.|
|Visual Inspection||A qualitative assessment of the cleanliness of a surface. This involves visually examining the surface to look for any signs of residue, discoloration, or other abnormalities.|
|Chemical Testing||Analyzes samples from surfaces for the presence of specific chemical residues, such as detergents or disinfectants.|
Can be done using analytical methods such as high-performance liquid chromatography (HPLC) or gas chromatography-mass spectrometry (GC-MS).
|Microbiological Testing||Involves collecting samples from surfaces and testing them for the presence of microorganisms, such as bacteria, fungi, or viruses.|
Can be done using techniques such as swabbing, air sampling, or surface contact plates.
|ATP (Adenosine Triphosphate) Bioluminescence Assay||A rapid testing method that measures the amount of ATP present on a surface.|
A high ATP reading indicates that the surface may still be contaminated and requires further cleaning.
The frequency of cleaning verification depends on a variety of factors, including:
- The type of facility
- The level of risk associated with the contamination
- The regulatory requirements governing the industry
In most cases, cleaning verification procedures should be performed after each cleaning cycle to ensure that the cleaning process has been effective. However, for facilities with a high risk of contamination, such as hospitals or food processing plants, more frequent verification may be necessary.
Regulatory bodies such as the FDA (Food and Drug Administration) require cleaning verification to be performed at regular intervals, typically as part of a cleaning validation program.
The frequency of cleaning verification may be specified in the facility’s standard operating procedures (SOPs), which outline the cleaning and verification protocols for each area of the facility.
Otherwise, verification is typically performed on a regular basis, such as daily or weekly.
|Cleaning Validation Protocol, Methodology and Occurrence|
|Surface Sampling Swabs||Used to collect samples from surfaces after cleaning to assess the level of residual contamination.|
Moistened swabs with a sterile buffer solution that helps remove continents for an acceptable residue level.
|Environmental Monitoring||Involves taking air or surface samples from the environment to detect and quantify the presence of microorganisms or other contaminants that may pose a risk of product contamination.|
|Rinse Water Testing||Involves testing rinse samples of the water used to rinse equipment after cleaning to ensure that it is free from contaminants.|
|High-Performance Liquid Chromatography (HPLC)||Used to identify and quantify the presence of specific residues or contaminants, like disinfectants.|
|Fourier-Transform Infrared Spectroscopy (FTIR)||Used to analyze samples for the presence of organic residues, such as proteins or lipids.|
|Microbiological Testing||Involves collecting samples from surfaces or equipment and testing them for the presence of microorganisms, such as bacteria, fungi, or viruses.|
Generally, cleaning validation should be performed at regular intervals to validate the effectiveness of cleaning processes and minimize the risk of contamination.
For some, this means the frequency of validated cleaning procedures may be specified in the facility’s standard operating procedures (SOPs), which outline the cleaning and process validation protocols for each facility area.
Cleaning validation and verification processes are essential for maintaining a hygienic environment, especially in high-risk settings such as hospitals, long term care facilities, and schools.
That’s why Optisolve’s cleaning validation tools, including the SAVI software and Pathfinder surface contamination imaging software, provide a comprehensive solution for cleaning quality management procedures.
By utilizing our tools, cleaning teams can easily record and analyze regular cleaning verification data and use detailed trend analysis for cleaning validation, ensuring that cleaning procedures are consistently performed to the highest standards.
With our solutions, you can rest assured that your facility is properly cleaned and disinfected, reducing the risk of contamination and infection. Our commitment to innovative and effective cleaning validation solutions makes us an essential partner for any organization looking to maintain the highest standards of cleanliness and hygiene.
Contact us now to cover your cleaning needs today.