Traditional Sterile Pharma Solutions

As a manufacturer of sterile drug products, safety, efficiency, compliance, and traceability are not only part of your daily lexicon—they’re central components of your mission. With a comprehensive portfolio of diagnostic solutions, bioMérieux, Inc. helps streamline workflows, boost productivity, and improve data integrity with both traditional and automated microbial testing methods. Together, we’ll harness the power of diagnostics to unlock your lab’s hidden value.

Environmental Monitoring

Can changing your culture media really impact your bottom line? With a guaranteed 12 weeks of dating upon shipment, LOCKSURE® lids to protect sample integrity, improved moisture control, and flex-temp storage ability, TSA 3P® plates can.

This combination of features allows you to order larger batches less frequently, cut down on incoming QC, deviations, retesting and paperwork so you focus on what you do best—keeping your lab running smoothly and ensuring your products are safe.

Add ALCOA compliance and streamline workflows with rapid growth promotion of your 3P plates with the EVISIGHT® COMPACT intelligent incubator system.

Microbial Identification Systems and Services

From manual identification with API® to state-of-the-art MALDI-TOF with VITEK® MS, bioMérieux offers the largest breadth of solutions for microbial identification.

Whether you are wanting our outsource all of your identifications or simply complement your in-house method, our identification experts at VITEK® Express ID Service can confirm a missed identification or obtain gene sequencing for critical samples.

Endotoxin Testing and Services

ENDONEXT™ endotoxin detection assays from bioMérieux are ushering in a new era of smarter, more sustainable pharmaceutical quality control.

Based on Recombinant Horseshoe Crab Factor C (rFC), ENDONEXT technology not only eliminates the need to harvest horseshoe crab blood—it makes your entire lab more efficient. With 100% endotoxin specificity, lot-to-lot consistency, and more streamlined workflows, ENDONEXT provides reliable results everywhere from in-process controls to final product testing on the most challenging matrices.

Sterility Testing and Microbial Detection

bioMérieux offers a full range of culture media and rinse solutions for traditional sterility testing. Our bottles and tubes are available in many configurations such as traditional serum bottles with septa, screw tops, combination screw top/septum and wide-mouth bottles. Many of our media and rinse solutions are available with individual removable outer wraps. Our cleanroom range features a non-shedding plastic box, double wrapped and sterilized with ethylene oxide, making them well-suited for use in an isolator.

In addition to traditional methods, we also offer rapid methods for in-process controls or final product release.

Quality Control Testing

BIOBALL® is a small, water-soluble ball containing a precise number of microorganisms, with a much lower standard deviation and higher recovery rate compared to serial dilution. With patented, proprietary technology and techniques, BIOBALL is making quantitative microbiological quality control more accurate and efficient than ever.

BIOBALL is available in all compendial strains as well as custom plant isolates.

Water Testing

Control of your water supply is critical. The combination of R2A 3P® and the automated intelligent incubator and plate reader, EVISIGHT® COMPACT to reduce errors and increase data integrity.

Our versatile ENDONEXT™ range can reduce both hands-on time and time to result for testing of water for endotoxins.

Pioneering Diagnostics