Cleanliness of critical sites in the sterile compounding process is crucial to ensuring the final sterility of CSPs. A strong EM program helps you see, measure and control risk. Our innovative solutions for surface, air, and personnel monitoring such as TSA 3P® media with room-temperature storage combined with the simple and powerful AIR IDEAL® 3P® air sampler will give you confidence in the safety of your critical compounding areas.
Microbial Identification Systems and Services
RELIABLE RESULTS, WHEN YOU NEED THEM
Whether you’re currently using traditional ID methods or sending samples out for identification, the experts at bioMérieux will help you get the results you need, when you need them with dependable identification of bacteria, yeasts, and molds in our GMP-compliant, ISO-accredited laboratory.
If you prefer to bring identifications in house, we offer a wide range of automated and manual solutions available with full validation support.
Endotoxin Testing and Services
WE’RE MAKING ENDOTOXIN TESTING FASTER, EASIER, AND ECOLOGICALLY FRIENDLY
The ENDOZYME II® GO assay is the enhanced second generation of ENDOZYME® — giving you reliable results within just 15 minutes. It provides endotoxin quantification in liquid biological samples, and is particularly suited for end-product testing and in-process control of water. Less handling, great results.
The ENDONEXT™ range of assays by bioMérieux is based on Recombinant Horseshoe Crab Factor C (rFC), which completely eliminates the need to harvest horseshoe crabs for their blood.
Sterility Testing and Microbial Detection
RAPID STERILITY TESTING FOR SAME-DAY RELEASE
The final sterility test is critical to knowing if the compounded sterile product you created is safe. Traditional methods are effective but take 14 days and CSPs are often limited in shelf lives so robust rapid microbiology testing is an effective way to ensure patient safety. Our rapid sterility solutions such as SCANRDI® and BACT/ALERT® 3D DUAL-T offer sterility verification results in as little as three hours.
Quality Control Testing
EASY, ACCURATE GROWTH PROMOTION.
Growth promotion is key to determining the ability of culture media to successfully recover and grow microorganisms. Though the concept is simple, the test itself can be challenging and technique dependent. Multiple steps and prolonged incubation are often required to achieve the target CFU count required by USP. BioBall® quantitative QC organisms’ unique format eliminates the need for incubation and dilution without compromising reproducibility.
Pair with the intelligent incubator and plate reader, EVISIGHT® COMPACT to reduce errors and increase data integrity.
ELEVATE YOUR WATER TESTING.
Combine the power of of R2A 3P® and the automated intelligent incubator and plate reader, EVISIGHT® COMPACT to reduce errors and increase data integrity.
Streamline your endotoxin testing with our ENDONEXT™ range of endotoxin testing solutions.