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. 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?"

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 advance II rapid microbial testing system
celsis adapt concetrator system

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.

Celsis Accel® system is specifically designed for small and mid-sized pharmaceutical, home, and beauty product manufacturing facilities with a smaller throughput of 30 assays per hour. It takes the robustness and ease of use of the widely adopted Celsis Advance II™ platform and packages it into an option for lower production facilities.

Celsis Accel system for rapid microbial detection

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 as little as 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. To learn more about how to build business case and other common drivers, download the eBook: Guidance on Implementation of Alternative and Rapid Microbiological Methods by Paul Newby, Ph.D.

Frequently Asked Questions (FAQs) about Rapid Microbial Detection Methods

  • What is rapid microbial detection?

    Rapid microbial detection is an alternative, modern method of detecting contamination in samples that provide results faster than traditional compendial methods. While also offering faster results, often in half the time of traditional methods typically based on visual confirmation, they also provide data integrity benefits through automated analysis and results reporting. Pharmaceutical, personal care, cosmetics, and cell and gene therapy manufacturers have adopted rapid microbial detections as a way to improve their manufacturing efficiency, reduce the risk of human error, and ensure patient safety.

  • What is a rapid sterility test?

    A rapid sterility test, in lieu of a traditional test, involves an alternative method of contamination testing for faster, more accurate results. For example, the ATP-bioluminescence method detects any amount of ATP present in samples using a reagent-based assay, thus proving the existence of contaminants such as bacteria or mold automatically. This method, along with our collection of validation services, allows QC laboratories to obtain faster turnaround times for sterility testing, bringing products to patients in need faster and with less chance of human error. 

  • What can I use a rapid microbial method 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.

  • 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.