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SCANRDI®

Bring Your Sterility Testing to the Next Level

SCANRDI® revolutionized rapid microbial detection when it was first introduced and still today its speed and sensitivity remain unrivaled.

Its unique technology delivers actionable sterility results in 4 hours or less, so you know you can continue with production or if you need to take action immediately.

When You Need to Know Now

SCANRDI® enables same-shift detection of microbial contaminants in filterable drug products. The US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory bodies support the use of validated Rapid Microbiological Methods (RMM) for sterile product release - especially in the case of shelf-life products, where a rapid result is more suitable than a compendial 14-day test.

Ultra-rapid

  • Same-shift results
  • Release your product faster

Accurate

  • Tested & proven technology
  • Make decisions with confidence

Compliant

  • Full validation support: URS completion guide, IOQ guide, primary validation guide, suitability guide and Drug Master File (DMF)
  • 21 CFR part 11 enabled software

Proven Technology

  • Long history of use for final product sterility, in-process bioburden control & water testing
  • Down to 1 microbe/filtrable volume
  • >200 compatible products

Broad Specificity

  • Universal fluorescent labeling
  • Bacteria, yeast, and mold detection

  

  

SCANFILTERTM

  • Enhanced user-friendliness, encompassing streamlined handling, optimal sample visibility, and effortless packaging access
  • Improved robustness with high-quality materials to minimize operator errors
  • Enhanced user experience facilitated by the device, necessitating minimal manipulation with heightened precision
  • Enhanced device functionality leads to increased workflow efficiency and reduced error risk

Improve Productivity and Compliance

Increase Your Market Competitiveness

  • Safely release your short shelf-life & generic products faster
  • Optimize your distribution logistics with just-in-time inventory management of stock and choose your most affordable shipping option

Control Your Manufacturing Process

  • Rapid in-process, bioburden and sterility results give you confidence that your production is operating properly
  • Facilitate your investigation process to quickly return to normal operations
  • Eliminate lab bottlenecks

Be Confident in Your Compliance

  • Ensure your electronic compliance with 21 CFR part 11 enabled software, barcode scanning traceability, several approval levels and a full audit trail
  • Feel reassured in your validation process with support from bioMérieux including URS completion guide, IOQ guide, primary validation guide, suitability guide and Drug Master File (DMF)

More Than 200 Compatible Products*

  • Antibiotics
  • Isotonic solutions
  • Chemotherapy drugs
  • Hormones
  • Anti-inflammatories
  • Anti-coagulants
  • Analgesics
  • Diuretics
  • Vitamins

* non-exhaustive list


SCANRDI® is a rapid, proprietary microbiological solution combining universal cell labeling and solid-phase cytometry with the ability to detect bacteria, yeasts, molds – both in vegetative and sporulated forms - and yeasts. Test applications include:

  • Raw material testing
  • Water testing 
  • In-process product testing
  • Chromatography columns health check
  • Investigations
  • Product release

As it’s a non-growth based method, stressed and fastidious organisms including those in VBNC state (Viable but Non-culturable) can be detected as well, making SCANRDI® a powerful tool to monitor and ensure the rapid detection of microorganisms in pharmaceutical products.

Downloads

Brochure - SCANRDI® - When you Need to Know Now Bring your Sterility Testing to the Next Level

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BROCHURE_SCANRDI_A4_05_23_9324097_Pages.pdf
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Services: Feasibility, Validation, and Instrument Support

With bioMérieux services, your productivity and product quality is our priority. Our mission is to provide the pharmaceutical industry with rapid, accurate, and cost-effective solutions to ensure smooth implementation and maximizing your return on investment.

 

Feasibility Studies

  • Quickly confirm the compatibility of your product and method

 

Validation Services

  • Expedite implementation of your investment by reducing validation time and expense

 

Instrument Service Plans and Support

  • Maximize the uptime of your instruments and ensure continuous operations

 

Smart Remote Support Solutions

  • VILINK® ensures the continuity of your operations

SCANRDI® - Bring Your Sterility Testing to the Next Level

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SCANRDI® - When You Need to Know Now

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