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BACT/ALERT® 3D

THE METHOD OF CHOICE FOR RAPID STERILITY TESTING

BACT/ALERT® 3D is an effective, safe and proven solution for industrial sterility testing.

From ease of use to flexible data management, BACT/ALERT® 3D is an innovative microbial detection system. Suitable for any size laboratory, it provides you with a reliable and objective alternative to traditional microbial detection methods.

The automated BACT/ALERT® 3D 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® 3D 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® 3D to release products.

  

Benefits

  • Fast results, simple workflow: Not only does BACT/ALERT® 3D 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® 3D 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® 3D 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.

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BACT/ALERT® 3D: Rely On A Proven Solution

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

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BACTALERT BEST PRACTICES - Final Art.pdf
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BACTALERT BEST PRACTICES - Final Art.pdf
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301 KB
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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

Features

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

Accepted By Regulatory Bodies

  • BACT/ALERT® 3D has been validated by numerous customers for product release and accepted by US Food and Drug Administration, European Medicines Agency & others.
  • Accepted as a compendial method for designated products:
    • Chinese pharmacopeia and EP 2.6.27 for cellular products
    • USP 72 for short shelf-life products

   

   

Innovative & Optimized Culture Media

The BACT/ALERT® Culture Media Bottles, used in conjunction with BACT/ALERT® 3D or BACT/ALERT® VIRTUO®, offer advantages across every dimension of microbial testing.

From the polycarbonate bottle for user safety and unique barcode for traceability, to the optimized media formulation, every laboratory can efficiently perform microbial detection to ensure consumer and patient safety.

Main Benefits

  • Ready-to-use media bottles minimize handling and contamination
  • Optimized formulation to ensure robust growth of bacteria, molds, and yeasts
  • Compatible for isolator use

Features

  • Unique identification barcode to ensure traceability
  • Compatible with any BACT/ALERT® instrument
  • Enhanced antimicrobial neutralization for challenging matrices

BACT/ALERT® Culture Media Bottles provide testing simplicity and confidence in results. Metabolic activity of microorganisms is detected using our patented colorimetric technology. Growing bacteria and fungi produce carbon dioxide that diffuses through the broth to the sensor located at the bottom in the bottle, whose color changes as a result of pH drop.

TRADITIONAL PHARMA, BIOPRODUCTION, ADVANCED THERAPIES AND MEDICINE PRODUCTS (ATMP):

AEROBIC

  • iAST
  • iFA+  for matrices needing neutralization 

ANAEROBIC

  • iNST
  • iFN+  for matrices needing neutralization
     

BLOOD BANKS:

  • BPA for aerobic platelet testing
  • BPN for anaerobic platelet testing
  • CE MARKING CERTIFICATION for quality control of platelet with BPA and BPN culture media bottles
  • FDA 510(k) CLEARANCE (Blood Banks) for quality control testing and safety measure secondary testing of platelets with BPA and BPN culture media bottles
     

FOOD AND BEVERAGE:

AEROBIC

  • iAST
  • iFA+  for matrices needing neutralization 

ANAEROBIC

  • iNST
  • iFN+  for matrices needing neutralization

YEAST & MOLD

  • iLYM

Support And Services Where And When You Need

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.

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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. 

 

Image Feasability Study

Feasibility Studies

We’ll prove the compatibility of your matrices with a validated bioMérieux platform depending on your microbiological specifications.

Validation Protocols 

We help you expedite the implementation of your investment by reducing validation time and expense.

Supply Services 

We help you minimize your administrative operations so you can focus on your core business activities.

Instrument Service Plans & Support

We support you with service maintenance and repairs, ensuring the reliable continuity of your operations.

Smart Remote Services 

Through our Smart Remote solutions VILINK®, EASY ASSIST and SELF ASSIST, we’re able to fix most of your issues remotely and assist your laboratory specialists in achieving full autonomy.

  

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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837 KB
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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® 3D 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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