One Rapid Micro Method. Multiple Applications
Expanding applications for rapid microbial detection beyond single quality control points has been a challenge for many QC microbiology labs because current, on-market rapid microbial analysis methods have provided limited application potential caused by inherent technological limitations like sample incompatibility. While many rapid micro methods have been implemented in the past, they have done so with a narrow scope, typically validated for only a handful of sample types or individual applications which best conform to the capability of such technology.
It’s no surprise that most QC microbiology laboratories have never considered the potential impact of a single rapid microbial method that’s capable of replacing multiple traditional in-process quality control tests for multiple sample types, including final product sterility.
From Cell Culture to Sterility and Everything in Between
Celsis’ amplified ATP-bioluminescence platform can test many different QC samples all along the production process and has been a trusted method for years thanks to its reliability and ease of use. Utilizing a synergistic combination of instruments, reagents, and an automation-controlled enzyme reaction, the ATP-bioluminescence assay confidently detects the presence of microbial ATP present in contaminating bacteria, yeasts, and molds.
Why Use Celsis?
Celsis® Sterility Equivalency (Membrane Filtration) Report
- A comprehensive 188-page report demonstrating statistical equivalency, limit of detection, and specificity of Celsis® to the traditional method.
Ruggedness Technical Report
Robustness Technical Report
Sterility Sample Effects Testing Protocol
Eliminates days of incubation
- Rapid sterility results in six days for traditional sterile drug products.
- Rapid sterility results in three days for ATMPs and short shelf-life products.
- Rapid bioburden/microbial limits results in as little as 24 hours.
Simple Flexible Test Methods
- Compatible with both membrane filtration and direct inoculation.
- Does not change current, prescribed sample preparation methods.
- Does not require dyes, stains, or multiple sample manipulations.
Complies with current good laboratory practices
- Non-destructive, conserving over 95% of the original incubated sample.
- Automated analysis and reporting.
- Compliant with FDA 21 CFR Part 11 and data integrity best practices.
Breaking through the long-perceived limitations of RMMs as single-application instruments, Celsis can replace multiple systems with a single, harmonized platform to convert many traditional method-based QC assays with a rapid presence/absence assay.
Cross-Industry Platform for Microbial Analysis
Learn how Celsis ATP-bioluminescence rapid detection can be applied to critical in-process control points.
Celsis Rapid Microbial Detection Product Line
The Celsis Advance II™ luminometer is our highest throughput instrument for rapid testing of a wide variety of products, from pharmaceutical and biotech to consumer goods and beauty. Capable of running 120 assays per hour, this instrument is best suited for large-scale manufacturing and high-volume daily QC testing.
The Celsis Accel® luminometer, with a throughput rate of 30 assays per hour, is a smart option for contamination control for small-scale manufacturers or for optimizing quality testing during research, development, or low batch size production.
The Celsis Adapt™ sample concentrator instrument expands the capabilities of the Celsis platform to cell therapies, and in-process cell culture samples. By concentrating samples and removing cellular components that interfere with the background and ATP-bioluminescence detection signal, it allows for rapid microbial detection on Celsis luminometers.
Frequently Asked Questions about Applications for Rapid Microbial Testing
What is the definition of a “rapid method”?
Rapid methods for quality control microbiology can be defined as an alternative method which reduces the time needed to obtain a result while remaining non-inferior to the traditional test method it replaces.
What is ATP micro testing?
ATP micro testing is a heavily documented and accurate bacterial and fungal detection technique which measures light emitted from a luciferin-luciferase reaction that occurs in the presence of microbial adenosine trisphosphate (ATP) molecules. This rapid microbiological method functions as a presence/absence assay and is capable of a limit of detection down to less than 1 colony forming unit (CFU) of contamination.
What is ATP testing used for?
ATP testing is used for bacterial and fungal contamination detection technique to ensure that pharmaceutical, biologic, personal care, cosmetics, dairy, beverage, and food products are free of adulteration by microbiological organisms. This method of testing must be able to confidently discern ATP molecules inherently present in the sample against ATP molecules made present in the sample from contaminating microorganisms.
Which assays can be replaced with rapid microbiological methods?
Rapid microbiological methods can provide a faster alternative to many traditional growth-based methods that rely on lengthy incubation periods to achieve visible growth. These include testing raw materials and in-process production control samples such as during cell culture, column chromatography, and purification steps. Additionally, rapid microbiological methods which provide a presence/absence result like Celsis® ATP bioluminescence provide a perfect replacement to the traditional sterility release test.
What are the advantages of a rapid microbiological assay?
The primary advantage of a rapid microbiological assay is the ability to detect contamination faster that impacts the viability of a production batch during routine quality control testing, reducing the ever-increasing risk of typical “at-risk production”. It will also help perform investigations or confirm the effect of corrective actions faster.
For example, if a traditional assay requires 3-5 days of incubation before results can be obtained visually, implementing a rapid microbiological assay that provides the result in just one day would allow a quality control group to detect the contamination, perform a microbial identification if needed, and begin an investigation before the traditional assay would have even be completed. A faster notification of a batch contamination to the manufacturing department will allow them to stop production sooner and reduce the risk of contaminating downstream equipment, which would require cleaning and sanitization remedial actions to be taken.
What is useful for conducting rapid microbiological tests?
In order to conduct rapid microbiological tests effectively, the right microbiological method should be selected and implemented. This method should be weighted against in-house user criteria and drivers that will serve the operation and financial goals of an organization.
It is also recommended to seek a rapid microbiological testing platform that has the flexibility to support multiple different assays to maximize the work required to implement and validate such a system, as well as the ease of implementing this at other sites if part of a global organization.