best rapid microbiology method used in the pharma labs

Microbiology Pharma: The Best Rapid and Alternative Methods

We asked the SuperMicrobiologists (over 10,000 followers on LinkedIn) which rapid (or alternative) methods they use in their microbiology laboratories.

Here are all the methods that were reported back to us. The choice is yours!

Content :

Red One by Redberry

Red One méthode rapide pour la détection de contaminants dans les produits pharmaceutiques et l'eau. Marque Redberry

Red One is a technology based on solid-phase cytometry. It enables rapid and automated enumeration of microorganisms. Real-time analysis of the assimilation of fluorescent markers by cells (labeling kinetics) provides an accurate count of microorganisms (direct measurement from 1 to 100ml).

Tests available

  • A rapid and quantitative “indicator” test for total bacterial load in 10 minutes (environmental controls of water and surfaces, strain bank enumeration, post-disinfection abatement rate monitoring).
  • A quantitative bioburden test in less than 4 hours (bacteria, yeasts, molds).
  • A sterility test meeting regulatory requirements in 3 days after enrichment in FTM and SCDM media.

Technology Advantages

  • Easy to use: Filtration, labeling, and analysis are automated. The device can be used in a production environment or in a laboratory (including under PSM).
  • Easy to interpret: The labeling technology allows for the discrimination of background noise from microorganisms without post-hoc microscopic control.
  • Post-analysis identification: In case of a positive result, identification with traditional methods is possible.

Technology “Limits”

  • Duration of analysis on the equipment: 10 minutes per sample (from 1mL to 100mL), i.e., 6 samples per hour (filtration included).
  • Possible detection of viable but non-culturable microorganisms: regulatory evolutions are necessary to fully integrate this aspect (method superiority).

We spoke with a pharma user in France who purchased Red One from Redberry. The system is currently being validated for a bioburden application on purified water.

link to Red One de Redberry

Contact Redberry : – Tell them you’re referred by SuperMicrobiologists.

Growth Direct by Rapid Micro Biosystems

Growth direct méthode de détection rapide des contaminants dans l'industrie pharmaceutique. Marque est Rapid Micro Biosystems

Growth Direct is an “intelligent” incubator. It automates incubation, counting, and data management for Petri dishes. Its technology based on auto-fluorescence allows for rapid detection of colonies (intermediate data after only 12-16h with final result in maximum 72h).

It consists of 2 incubators, each with a capacity of 330 dishes allowing for serial (or single) incubation.

Tests available

  • Environmental controls (air, surface) results in 56-72h.
  • Bioburden result in 36h.
  • Water in 88h.

Technology Advantages

  • Early decision-making: In case of suspected contamination, the system does not wait for the end of incubation to alert the lab (alerts as early as 12-16h of incubation).
  • Securing data integrity: all data are recorded and communicated directly to the LIMS.
  • Time-saving in the lab: Microbiologists no longer need to count Petri dishes and can focus on higher-value tasks.

Technology “Limits”

  • Only one dish size (55mm) is available (however, Growth Direct offers equivalence data for 90mm dishes).
  • Captive consumables linked to the auto-fluorescence technology. Only Petri dishes sold by Growth Direct can be used.

We spoke with a user in France, who has validated and is using Growth Direct routinely for all their environmental controls. Results in 56 hours instead of 5 days. There are a little over 70 systems installed in Europe (130 worldwide).

Link to Growth Direct de Rapid Micro Biosystems

Contact Rapid Micro Biosystems : – Tell them you’re referred by SuperMicrobiologists

IAN from Microbs

IAN méthode rapide de détection des contaminants dans l'industrie pharmaceutique. marque Microbs

Ian is a solid-phase cytometer coupled with artificial intelligence. This technology allows for the detection and quantification of microbial contaminations in 15 min.

We have limited information regarding the labeling principle. We only know that the implementation of the markers is sequential, which would allow for better discrimination between particles and microorganisms. Optimized formulation to improve spore labeling.

Tests available

TVC (Total Viable Count) for water (bioburden), environmental controls (swabbing), but also finished products (sterility test) in 15 minutes. 

Technology Advantages

  • Fully automated: Filtration and reagent addition are automated, no manual handling required.
  • No expertise required: No interpretation of results. The technology provides a final result in the number of living microorganisms per volume analyzed.

Technology “Limits

  • Analytical throughput: limited to 4 samples per hour.
  • Possible detection of viable but non-culturable microorganisms: regulatory evolutions necessary to fully integrate this aspect (method superiority).

Link to IAN de Microbs

Contact Microbs : –  Tell them you’re referred by SuperMicrobiologists.

Celsis from Charles River

Celsis permet via l'ATP la détection de contaminants dans les produits pharmaceutiques. Marque Charles River

The Celsis method uses an amplified ATP bioluminescence technology. The word “amplified” is key here.

Indeed, a specific reagent developed by Charles River amplifies the ATP signal to allow for much quicker contamination detection than with non-amplified ATP.

Tests available

  • 5 to 7 days for sterility.
  • 48 hours for microbial bioburden.

Celsis can be used for finished products, in-process controls, purified waters, pharmaceuticals, cosmetics, and cell and gene therapy products.

Technology Advantages

  • Validation “facilitated”: Charles River offers validation support packs, with the possibility of completely outsourcing the tests to an accredited laboratory (accepted by authorities for sterility tests).
  • No interpretation: after analyses, the report is automated, reducing human errors and improving data integrity.
  • Easy to use: After incubation, the sample is analyzed by an automaton that will add the reagents, perform the analysis, and deliver the results.

Technology “Limits”

  • The amplified ATP technology, being a presence/absence detection, will be reserved for sterility testing and microbial limit tests on “clean” matrices

We spoke with a user in France who is currently finalizing the validation of a sterility test for injectable solutions. Results in 7 days instead of 14 days. There are 800 Celsis systems installed in 65 countries.

Link to Celsis from Charles River

Contacts Charles River: – Tell them you’re referred by SuperMicrobiologists.

7000RMS from Mettler Toledo

Mettler toledo 7000RMS permet de surveiller les contamination dans les boucle d'eau pharmaceutique

The 7000RMS continuously monitors (every 2 seconds) and directly the microbial load present in a water loop.

This analyzer is directly connected to a water loop. Whenever microorganisms pass in front of its laser, it induces fluorescence which allows for the detection and quantification of microorganisms.

Test available

Bioburden in pharmaceutical-use waters: Continuous and real-time.

Technology Advantages

  • Continuous monitoring: Contaminations are not always uniform (e.g., biofilms), so taking spot samples can introduce analytical bias. With this technology, the water loop is continuously monitored.
  • Immediate results: The detection of the presence of microorganisms is instantaneous. Corrective action can therefore be quickly implemented.
  • Optimization of disinfection cycles: This technology allows for quick verification of a water loop cleaning’s effectiveness.

Technology “Limits”

Will the 7000RMS replace filtration and Petri dishes? Maybe not initially. It is seen more as an additional tool to continuously monitor what’s happening in water loops.

Lien to the 7000RMS

Contact Mettler Toledo – Tell them you’re referred by SuperMicrobiologists.

The others RMM

Other RMMs mentioned by the SuperMicrobiologists are: ScanRDI, BactAlert, and Milliflex.

What about you? Which RMM have you chosen? Come share your experience in the comments.

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