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BACT/ALERT® 3D

THE METHOD OF CHOICE FOR RAPID STERILITY TESTING

The BACT/ALERT® 3D was developed as an effective and safe solution for industrial sterility testing.

From its ease of use to its flexible data management, the BACT/ALERT® 3D is a state-of-the art microbial detection system suitable for any size laboratory, providing you with a reliable and objective alternative to traditional microbial detection methods.

The automated BACT/ALERT® solution simplifies testing and makes it easy to monitor any point of your manufacturing process. This proven solution has been in the game of industrial testing for more than 15 years and will guarantee flexibility and simplicity because anyone can perform the test anywhere at anytime of the day. 

BACT/ALERT® is used by more than 700 users around the world in the food and pharmaceutical industries, with more than 80% of the top 20 big pharma companies relying on BACT/ALERT® to release products.

Benefits

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BACTALERT BEST PRACTICES - Final Art.pdf
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BACTALERT BEST PRACTICES - Final Art.pdf
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BACTALERT BEST PRACTICES - Final Art.pdf
Size
301 KB
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  • Fast results, simple workflow: Not only does BACT/ALERT® cut traditional sterility testing time in half*, you also minimize your hands-on-time with only 3 steps required: innoculate, scan, and load.
  • Continuous monitoring: Ensure consistency and real-time awareness of your sterility testing process with early alerts that can help you take quick, corrective actions. 
  • Incredibly flexible: BACT/ALERT® is compatible with a broad range of matrices—even the most complex—and can be used for both in-process and release testing.
  • Proven solution: BACT/ALERT® has been validated by numerous customers for product release and approved by US Food and Drug Administration, European Medicines Agency, and others.  

 

* Timeframe must be validated by customer. 

Features

  • Automated, reliable, and objective microbial detection with built-in quality control
  • Easy-to-use with a streamlined workflow
  • Ready-to-use media bottles
  • 21 CFR Part 11-compliant data management system
  • Non-destructive sterility testing for subsequent identification
  • Growth monitoring every 10 minutes

Uses

Using our patented colorimetric technology and the innovative BACT/ALERT® Culture Media Bottles, BACT/ALERT® 3D detects a wide variety of microorganisms, including bacteria, molds, and yeasts.

  • Bacterial platelet quality control
  • Aseptic foods and beverages
  • Sterility testing of pharmaceutical products (traditional and bioproduction)
  • Advanced therapies and medicinal products
  • Blood banks (bacterial platelet quality control)
    • CE Marking Certification for quality control of platelets with BPA and BPN culture media bottles
    • FDA 510(k) clearance for quality control testing and safety measure secondary testing of platelets with BPA and BPN culture media bottles

Support

  • Validation IQ/OQ/PQ1 for USP compliance
  • Feasibility studies

BACT/ALERT®: Rely On A Proven Solution

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This proven solution allows virtually anyone to test for product contamination anywhere, at any time. 

BACT/ALERT® 3D DUAL-T BROCHURE

Download the brochure to learn more about this complete solution for automated sterility testing.

DOWNLOAD BROCHURE

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PHARMA_BROCHURE_BTA_3D_DUAL_T_A4_03_24_9326503_Pages.pdf
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POSTER -  HOW RAPID MICROBIOLOGICAL METHODS ENABLE OPERATIONAL EFFICIENCIES, FROM ROUTINE PRODUCT QUALITY TESTING TO PROCESS FAILURE INVESTIGATIONS

Download the poster that demonstrates that implementing rapid microbial methods for routine product quality testing and quality investigational tools improves operational efficiency for bioproduction manufacturers. 

DOWNLOAD POSTER

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PDA-Poster-Case Studies – How Rapid Microbiological Methods Enable Operational Efficiencies.pdf
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POSTER -  A COMPARATIVE PERFORMANCE STUDY OF ADJUSTED BACT/ALERT® iFA PLUS FOR GROWTH PROMOTION AND ANTIMICROBIAL NEUTRALIZATION

Download the poster to learn about a series of studies that determined the impact of the addition of trace elements on growth promotion as well as the ability to neutralize a range of antimicrobials.

DOWNLOAD POSTER

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PDA-Poster-Comparative performance study BACT-ALERT.pdf
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272 KB
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BACT/ALERT® BEST PRACTICES

Download the one-sheet to learn about which bottles to use for which application, why growth promotion testing is important, and how to properly innoculate and incubate bottles.

DOWNLOAD ONE-SHEET

Filename
BACTALERT BEST PRACTICES - Final Art.pdf
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301 KB
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application/pdf