Is Your Hospital or Compounding Pharmacy Achieving Fast and Successful Releases?
With a comprehensive range of microbial control solutions bioMérieux delivers the rapid and accurate results you need in order to protect your consumers, differentiate your brand and boost your bottom line.
Monitoring quality in microbiology is critical and challenging for pharmaceutical companies. While hand transcription remains the standard procedure in use, these daily processes often rhyme with errors leading to time-consuming investigations, and not fully compliant data.
Environmental monitoring (EM) is the main microbiological control performed by pharmaceutical industries. While multiple hand-written and transcription operations remain the standard procedure in use for thousands of samples per month, the daily processes often result in errors leading to time-consuming investigations, low value-added tasks and data that is not fully compliant. As a result: major impacts on batch release, on process efficiency and ultimately patient safety.
AIR IDEAL® 3P®
AIR IDEAL® 3P® is used for the detection of viable organisms through active air sampling.
API® makes microbial identification simple and reliable. Combining a standardized method with an extensive and robust digital microbial ID knowledge base, API® can easily be implemented into any microbiology laboratory.
The BACT/ALERT® 3D was developed as an effective and safe solution for industrial sterility testing.
BIOFIRE® Mycoplasma provides simple, accurate, and rapid in-house mycoplasma detection for use in testing raw materials, in-process samples, and final product release. We offer validation services designed to meet regulatory requirements—from documentation to comprehensive on-site support.
CULTURE MEDIA For Sterility Testing
Detecting contaminants is a critical step for the release of sterile pharmaceuticals. Effective and reliable culture media will allow for the detection of any possible contaminant in your products, ensuring patient safety.
ENDONEXT™ endotoxin detection assays are ushering in a new era of smarter, more sustainable pharmaceutical quality control.
The phenomenon of Low Endotoxin Recovery (LER) has gained renewed attention in the scientific community in recent years as the FDA now requires that all new Biological License Applications are able to successfully unmask when LER occurs. ENDOXPERTS™ is our solution for unmasking LER, which helps you meet regulatory requirements.
ENDOZYME® II GO STRIPS
Laboratories don’t always need to test all 20 samples to fill a full plate—that’s why ENDOZYME® II GO STRIPS are designed with flexibility in mind: the flexibility to use only what you need, when you need it