Cleaning validation with ATP : Everything You Need to Know

What does ATP stand for?

‘Mitochondria is the powerhouse of a cell’ is a phrase that should be engrained from many science lessons in school, but what exactly gives the mitochondria its power-like abilities? The answer is an intracellular small energetic molecule called ATP (Adenosine Triphosphate). ATP works by forming high energy bonds through the consumption of one of its phosphorus molecules, changing ATP into ADP. Although mitochondria are not present in many microorganisms like bacteria, they still produce and use ATP through different means, as ATP is the common ‘energy currency’ that provides fuel for most cellular activities. Therefore, ATP could be regarded as the ‘powerhouse molecule’ of most living organisms.

What is an ATP monitor?

Upon this concept, the use of ATP bioluminescence monitors was established. These devices measure the level of ATP amounts on a surface to determine whether there is residual organic matter present after the sanitization of an environmental surface, a medical device, or a surgical instrument. As mentioned previously, most living organisms produce and use ATP. The identification of ATP directly correlates to the presence of organic matter, this could be live or just debris from the impact of a sanitization process. For instance, here at Test labs, we use ATP bioluminescence monitors as a secondary means of protein identification for IFU (instructions for use) validations (ISO 15883-5:2021).

Cleaning efficacy validation using ATP monitors

The validation of IFU is a requirement of the MDR EU 2017/745 to tackle the growing concern within the medical device scene about the reprocessing of medical devices and its effects on the intended use of the device. The ISO 15883-5:2021 standard comprises of a cleaning process on a medical device based on the manufacturers IFU, and subsequent analysis of at least two analytes that indicate the presence of organic matter, of which one analyte that Test Labs measure is ATP. Post-cleaning, any residual ATP is collected from the sample and measured using the ATP bioluminescence monitor. The importance of the ATP monitor in this standard is to quantify the level of debris in the form of ATP that remains after the cleaning procedure. The presence and quantification of ATP on a medical device would verify the cleaning efficacy. Hence, the ATP test measurement is essential in validating whether the instruction for use (IFU) is efficient in cleaning a sample. If the sample reads at an ATP level above the alert level (22 femtomoles of ATP/ cm2) as per ISO 15883-5 acceptance criteria, then the IFU is deemed unacceptable, read more here about a case study on the IFU of dental instruments by Test labs. This similarly occurs in multiple hospital settings which utilize ATP bioluminescence monitor devices as an ATP-based sanitization monitoring system.

How does the ATP bioluminescence monitors work?

ATP is measured through a bioluminescent reaction between the enzyme luciferase and the substrate luciferin. Only in the presence of ATP, the luciferase reaction occurs, producing a bioluminescent signal. This signal is proportional to the amount of ATP within a sample; hence a strong signal indicates high amounts of ATP, and hence a high amount of organic matter in a sample. However, ATP monitors do have their limitations. The biggest shortcoming is that ATP bioluminescence monitors are unable to detect viral organisms due to viruses not containing or producing ATP on their own.

In today’s world, where hygiene is of paramount importance, the significance of sanitization cannot be overstated. ATP bioluminescence guns offer a reliable and efficient method for validating the cleaning of reusable medical instruments. By detecting residual organic matter on surfaces, these devices can confirm the efficacy of the cleaning process, ensuring that medical instruments are safe to reuse.

Explore how we can support your medical device journey to the market

Medical Device Biocompatibility Testing

We offer tests which evaluate cytotoxicity and biological risks within the chemical make-up of a medical device.

IEC 60601-1 Pre-Compliance Evaluation

We test your device, mitigating the cost of repeated compliance testing by evaluating potential non-compliances.

Disinfection products for medical devices

We test the efficacy of a wide range of disinfectants for medical devices, including disinfection technologies and robots.

Share article
Related Articles

You may also like