Release Safer, Cleaner Products with Celsis® Rapid Microbial Methods (RMMs)
Rapid microbial detection methods enable users to expose microbial contamination in a matter of hours as opposed to the days required for traditional methods.
Celsis Advance II™ system is designed to deliver definitive results quickly. Capable of running 120 assays per hour, high throughput manufacturers can cut days off their production cycles and reduce working capital requirements.
Celsis Accel® system takes the robustness and ease of use of the widely adopted Celsis Advance II™ platform and packages it into a small footprint. With a throughput of 30 assays per hour, this system is specifically designed for small and mid-sized pharmaceutical, home, and beauty product manufacturing facilities.
By combining a simplified workflow, automated analysis, and an extensive product compatibility portfolio, Celsis® rapid microbial detection systems optimize the way pharmaceutical and consumer care industries release product safely. Using ATP-based bioluminescence, an industry-proven rapid microbiological method, our instruments provide objective, and, most importantly, a confident answer to the question, “Is my product clean or not?"
Building the Business Case for Rapid Microbiology
Traditional quality control testing methods require 3–7 incubation days for bioburden or microbial limits (MLT) and, for sterility, more than 14 days of non-value-add incubation at every point of microbiological testing. This builds unnecessary risk into the production process in the event of a contamination failure, additional inventory storage requirements, product hold times, and delays to market.
In contrast, Celsis® rapid microbiology delivers results in just 18–24 hours for bioburden and microbial limits and just 6 days for sterility testing results, less than half the time of that required by traditional methods. The Celsis rapid microbial detection system provides actionable information at a critical decision point: information that enables you to rapidly confirm the quality of your product, improving your company’s overall profitability, and minimizing risk through:
- Shortened production cycles
- Decreased working capital requirements
- Reduced lab waste to improve sustainability
- Faster response to contamination and shorter investigations
- Reduced inventory requirements and safety stock
By creating a more streamlined, responsive, and lean manufacturing process, Celsis® rapid microbial detection drives supply chain efficiencies, reduces contamination response and investigation times, and maximizes production and testing throughput. Available in multiple sizes to suit every business need and industry, rapid microbial detection systems will transform the way you do business.
Rapid Microbial Detection Resources
- STAT Results for STAT Samples: Implementing Modern Rapid Micro Methods
- Presented by Dr. Wayne DeHaven, Pharmetic Laboratory
- Celsis For Sterility: Validating a 7-Day Direct Inoculation Sterility Test Using the Celsis Advance®
- Presented by Dr. David Roesti, Novartis AG
- Celsis® For Sterility: Validating a 7-Day Membrane Filtration Sterility Test
- Presented by Stefan Gartner, Labor L+S
- Rapid ATP-Bioluminescence for Non-sterile Product Testing: Roadmap to Implementation
- Presented by Inge Van der Schoot, Janssen Senior Scientist
- STAT Results for STAT Samples: Implementing Modern Rapid Micro Methods
- Demonstrating Method Suitability of mRNA-based Therapeutics with Celsis AMPiScreen® amplified-ATP bioluminescence
- Celsis® ATP Bioluminescence For Testing of Microbial Contamination in Disposable Personal Care Wipes
- Demonstrating Method Suitability via Sample Effects of Celsis AMPiScreen® with Cell Culture Growth Media
- Demonstrating Method Suitability of Column Chromatography Resin Matrices with Celsis AMPiScreen® amplified-ATP bioluminescence
- The Sterisart® Septum Enables Reliable Sampling from a Closed System Sterility Testing Unit
- Determining Proof of Concept of an Alternative Sterility Test Using Celsis AMPiScreen® Amplified ATP Bioluminescence on a Broad Range of Pharmaceutical Products
- Ignar, R., English, D. and Jimenez, L. 1998, Rapid Detection of Microbial Contamination in Triclosan and High Fluoride Dentifrices Using an ATP Bioluminescence Assay. Journal of Rapid Methods and Automation in Microbiology 6, 51-58
- Scientific Posters
In the Industry
- Pfizer’s Implementation of a Celsis® Rapid Sterility Method
- Building a Strong Foundation for AstraZeneca’s House of Rapid Sterility
- Roche Diagnostics Case Study Overview: How to Gain Regulatory Approval for a Rapid Sterility Test
- Roche Diagnostics Presentation on The Journey of Implementing a Rapid Sterility Test
- If It Isn't Broken, Still Consider Fixing It: The Time for Rapid Microbial Methods is Now!
Frequently Asked Questions (FAQs) about Rapid Microbial Detection Methods
What can I use an RMM to test?
Rapid microbial methods are an ideal solution wherever there is a benefit in obtaining a faster time-to-result than the traditional method. However, the potential applications for rapid microbiology are much wider and more ubiquitous than this. Most traditional methods, involving enumeration or visual confirmation of contamination can be replaced with a rapid detection method. These include purified water, water for injection (WFI), microbial limits, bioburden counts typically expected to be 0 CFU, critical in-process steps, and for incoming raw materials.
Rapid microbiological methods are so expensive, how could I afford them?
Rapid methods are expensive relative to the traditional method, when viewed solely through the lens of a cost-per-test comparison. With this in mind, it’s correct to consider them more expensive in the short-term, but incorrect to consider them more expensive in the long-term. Many labs fail to include the operational and day-to-day advantages that a faster time-to-result provides, such as reducing investigation times, confirming contamination response actions were effective, and resuming production faster. These improvements all make an RMM deliver cost savings that outweigh its initial capital expense.
What if I don't need a faster time to result? What other benefits can rapid microbiological methods provide me?
The benefits of rapid microbial detection extend beyond just a faster time to result for quality control testing. While a faster result is the major positive impact of Celsis® rapid detection that users obtain, users also gain the ability to address and meet data integrity expectations and requirements from governance agencies. With its fundamental technology, using ATP-bioluminescence detection, along with its luminometer and software, Celsis® replaces the subjectivity of traditional enumeration or visual confirmation with an automated, reagent-based assay, controlled by an instrument. Results are controlled and reported through the software, avoiding transcription and interpretation errors potentially caused by an analyst recording and reporting handwritten results. Instrument usage and history can also be viewed using the system log, which can help meet audit trail requirements.
Do rapid microbial methods need to be validated before I can use them? How do I validate them?
Yes, implementing a rapid microbial method is an alternative method to your traditional, compendial method, which was validated prior to use as well. Historically, this task was considered very difficult and a barrier to entry for QC microbiology labs not familiar with alternative rapid methods. However, regulatory agencies and industry consortiums have responded and have published additional guidance documentation to assist implementation. Additionally, technology suppliers have been encouraged to do so as well. Charles River can provide guidance on how to implement Celsis®, as well as additional services and support when feasible.
Additional industry guidance documents can be found using the following links:
What should I do if I get a positive result?
It is recommended that any detected microbial organisms be identified to the species level. The most reliable and accurate microbial identification method is DNA sequencing, which is the basis of our AccuGENX-ID® service. Another technology for identifying routine microbial samples is MALDI-TOF, which we offer as AccuPRO-ID®, or as Axcess® , our in-house solution. Charles River’s proprietary, validated microbial databases are the key to the most accurate identification results.