The Future of Environmental Monitoring: Integrating and Validating the Next Generation of Automated Solutions
For drug developers, manufacturers and diagnostic testing companies such as bioMérieux, the safety of their end consumer – patients – is their greatest priority. Even minor lapses in production processes or product testing of pharmaceuticals can create significant risks for the safety of patients, as well as undermining public confidence in the wider healthcare industry.
Companies working in this field must pay attention across the whole product chain to reduce risks and center patient safety. Such measures include ensuring the quality and consistency of raw materials, handling and storing raw materials appropriately, initiating well-designed manufacturing processes that minimize contamination and conducting effective environmental monitoring (EM).
Why is EM essential for drug manufacturers to be robust and compliant?
Through the collection of data relating to the numbers or incidents of microorganisms present on surfaces, in the air, in water and from personnel, robust EM can help provide early warning of potential issues with environmental control measures. In situations where an issue is detected, EM gives manufacturers the data and information to investigate, establish potential risks to the product and set corrective or preventative actions in motion. EM is also a prerequisite for compliance with industry regulations, with agencies including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency requiring pharmaceutical manufacturers to have an EM program in place to ensure that aseptic processing is possible.
How are digitalized and automated technologies helping to improve EM?
As with all processes that rely heavily on human involvement, traditional methods for EM have their limitations and drawbacks. Manual data collection for EM is prone to errors and inconsistencies, can be very labor-intensive and time-consuming to complete and can create challenges for accurately maintaining an audit trail.
By comparison, digitalized and automated solutions allow for real-time data collection and analysis, ensuring any deviations can be immediately detected and addressed. By limiting human involvement, such solutions can reduce error and streamline processes that would be time-consuming for human workers. Automated solutions are capable of centralizing EM across different sites, enabling managers to access data from anywhere and in real-time. The use of automation tools also supports the identification and analysis of data trends, helping to predict breaches and equipment failures before they even occur.
The importance of validating new automated methods of EM
One key challenge of working with automated solutions is ensuring that they can provide results that are as accurate and consistent as those gathered via traditional methods. It is therefore crucial to ensure the system’s analytical performance has been validated using robust methodology to demonstrate its equivalence to traditional methods.
Validation also ensures that new EM systems using automated technology are in line with relevant regulatory requirements, offering reassurance to other stakeholders that these systems are producing trustworthy and compliant data.
Introducing 3P® STATION, the newest innovation in automated EM
bioMérieux has long been at the forefront of innovating end-to-end solutions that harness the capabilities of automated technologies to provide reliable and performant results for EM. One of the company’s most recent developments comes in the form of 3P® STATION, part of the 3P® ENTERPRISE solution which has been designed to meet the highly specific needs of the pharmaceutical industry.
The 3P® STATION is an automated Incubator/counter which incubates 90mm and COUNT-TACT® plates. Unlike traditional methods for plate inspection, the 3P® STATION automates the process and delivers real-time quantitative data on the presence of microbiological colonies. A further benefit of the 3P® STATION is that it produces high-quality pictures of plates every hour with a high-resolution camera and advanced telecentric optical lens. These special features of the 3P® STATION allow teams to trace the entire growth evolution of colonies present on plates and take action as soon as alert thresholds are reached.
Performance validation of 3P® STATION
At bioMérieux we aim to provide solutions that are fully validated, and which can consistently perform in line with demonstrated results. To support this, we have developed a validation strategy to test the counting performance of 3P® STATION and demonstrate its equivalence to traditional methods. Our validation approach compares the manual end-point reading and 3P® STATION automated methods. 1
A methodology was developed to establish a ‘reference traditional count’ that offers a truly accurate, robust, and unbiased comparison that both machine and human counts could be measured against: 1
The 3P® STATION has been validated following an automated compendial approach. Three counting performance attributes were assessed to demonstrate equivalency:1
- Accuracy – measured by linear regression versus the reference count.
- Limit of detection – measured using the false negative rate at a colony and plate level versus the traditional method.
- Specificity – measured using the recovery rate per strains and false positive rate at plate level versus the reference count.
Across testing, 86 strains commonly found in pharmaceutical environments and mixtures of these strains were used to ensure representation of real EM samples. Strict acceptance criteria were included to demonstrate equivalency1. Results of the rigorous testing showed that the 3P® STATION delivered equivalency in counting performance to the manual end-point reading method.1 Specifically, results demonstrated:1,2
- Accuracy – The 3P® STATION’s regression line compared to the reference count was acceptable for intended use for pure molds and compliant to the acceptance criteria for bacteria and mixtures.
- Limit of detection – The false negative rate at the plate level was 0% and at a colony level was statistically equivalent to the operator’s false negative rate.
- Specificity – The false positive rate at the plate level was 0.68% and the recovery rate was superior to 90% for all 86 strains tested.
In addition, to demonstrate equivalency of the global variability, a ruggedness study was performed using 36 different configurations. Testing consisted of different equipment, operators and plate batches on separate days.1 Results demonstrated no impact of the equipment on variance and no significance between 3P® STATION and the traditional method variance.1,2
This primary validation of the 3P® STATION is crucial in providing users with confidence in the accuracy and consistency of results to facilitate implementation, validation, and reliable decision-making. It is especially essential for drug manufacturers to make sure the technology they choose to implement for EM is reliable and in line with their expectations when applied to routine use.
The role of 3P® STATION in the future of EM
It’s clear that effective EM is key to assuring the safety of drug therapeutics, and the expanded use of more automated solutions has the potential to modernize these vital processes. By successfully harnessing automated solutions we can reduce the need for manual interventions in EM. This in turn can minimize errors and contamination risks, enhancing the reliability of results and ultimately raising standards of environmental control to the benefit of patient safety.
The 3P® STATION is a compelling example of this type of automated technology, with the potential to transform the way pharmaceutical manufacturers undertake a decades-old practice in EM. Securing uptake of these types of automated solutions should demonstrate that not only can this new technology seamlessly integrate and enhance current processes, but that the results produced can be trusted just as much as those gathered by traditional methods. For this reason, testing these technologies with robust methodologies is incredibly important, and should remain a key priority for developers.
References
1 Challenges and solution for performance validation of EM automation. Bailac L, et al. Poster presented at 2023 ISCT Annual Meeting, Paris. Available at: https://www.biomerieux.com/content/dam/biomerieux-com/03----our-offer/pharma-resources/posters/Poster%20CHALLENGES%20AND%20SOLUTION%20FOR%20PERFORMANCE%20VALIDATION%20OF%20EM%20AUTOMATION%20-%20ISCT%202023.pdf.coredownload.pdf Last accessed September 2024.
2 Challenges and solution for performance validation of EM automation. Bailac L. Presentation at 11th PharmaLab Congress, Dϋsseldorf.
