SCANRDI®
Sterility Results In 4 Hours Or Less
SCANRDI® is a rapid microbial detection system enabling same-shift detection of microbial contaminants in filterable drug products, answering the market's need for enhanced speed and sensitivity.
Its unique solid-phase cytometry technology delivers actionable sterility results in just 4 hours, so you you can quickly determine whether to continue with production or take immediate action.
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Rapid Microbial Detection System for Same-Shift Sterility Results
When You Need To Know Now
The US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory bodies support the use of validated Rapid Microbiological Methods (RMMs) like SCANRDI® for sterile product release, especially in the case of short shelf-life products, where a rapid result is more actionable than a compendial 14-day test.
- Filter
- Label
SCANFILTER™: An Innovative Addition To Your Sterility Testing Process
Combine your SCANRDI® instrument with SCANFILTER™, our complementary filtration device.
- Easy to use: Streamlined handling, optimal sample visibility, and effortless packaging access
- Improved robustness: High-quality materials to minimize operator errors
- Enhanced device functionality: Minimal hands-on time required
Increase workflow efficiency and reduce risk of error with SCANFILTER™.
Improve Productivity and Compliance
Increase Market Competitiveness
- Safely release your short shelf-life & generic products faster with same-shift sterility results
- Optimize your distribution logistics with just-in-time inventory management of stock and take advantage of affordable shipping options
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 a URS completion guide, IOQ guide, primary validation guide, suitability guide, and Drug Master File (DMF)
Ultra-Rapid
- Same-shift results in 4 hours or less
- 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
Robust Technology
- Long history of use for final product sterility, in-process bioburden control, and water testing
- Down to 1 microbe/filtrable volume
- >200 compatible products
Broad Specificity
- Universal fluorescent labeling
- Bacteria, yeast, and mold detection
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, and molds (both in vegetative and sporulated forms). 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.
Services: Feasibility, Validation, and Instrument Support
Your productivity and product quality are our priority. At bioMérieux, we aren’t just selling fast and reliable solutions – our technical team and scientific experts are fully committed to help you get the most out of your equipment, to ensure the continuity of your operations.
From feasibility, to installation and IT integration and training, our entire range of services can be customized to your needs throughout your whole journey with us, focusing on your core business and optimizing your resources.
Resources
Partner With bioMérieux For Fast, Accurate Sterility Testing
SCANRDI® supports rapid microbial testing for pharmaceutical manufacturing, in-process control, water testing, and final product release.
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