Quality – Reliability – Variety


Sterility Testing

Sterility testing is required for monitoring all products that are manufactured according to GMP and purporting to be sterile. But not all sterility testing solutions are created equal. Quality, convenience and suitability can vary greatly – affecting the credibility of your findings. Indeed, false negative results may lead to the release of contaminated products, with potentially severe consequences for both patients and manufacturers. On the other hand, cross-contamination and false positive results would imply lengthy and costly investigations, as well as possible product hold or rejection.

  • Extensive product portfolio meets all requirements for critical and controlled testing environments 
  • Consistent, high-quality products for accurate and reliable sterility test results 
  • Competence in regulatory and customer-specific requirements 
  • Product services: Application and method development, PQ consulting support, and training 
  • Instrumentation services: Validation protocols,
    on-site equipment validation (IQ/OQ), calibration and preventive maintenance 

Quality

With a broad range of high-quality products, ready-to-use validation protocols, and comprehensive services, we provide optimal solutions for all your sterility testing applications. We offer more than 40 years of expertise in compliance of regulatory requirements for sterility testing. Manufacturing and validation are performed according to stringent quality standards in ISO® 9001:2000-certified facilities.

Reliability

We are the leading manufacturer of sterility testing systems. The Steritest™ closed filtration devices were invented more than 40 years ago to minimize the risk of false results and have been proven to be the most reliable filtration devices available on the market. When used in combination with our Steritest™ Pumps, with automatic closure and SOP assistance mode, and our Steritest™ media and rinsing solutions, the results are of unmatched reliability.

Learn more about our Steritest™ EZ-System and how to:
  • Eliminate inhibition from products with antimicrobial properties
  • Test viscous or oily products such as creams and ointments

    Download Application Note

    Variety

    We provide a broad range of culture media and fluids suitable for virtually any sterility testing application. These applications include:

    • TSB for media fill 
    • FTM/TSB media for filterable samples 
    • Media intended for direct inoculation

    Serving as your one-stop supplier, we have based our range on extensive experience in sample preparation devices, hardware equipment, culture media, rinsing fluids and services for equipment and methods. But we don’t stop there. We are continuously developing new products and services to help you optimize your sterility tests with maximum safety and confidence. When results count, you can count on us.

     
     
    Sterility Testing Application Note

    Application Note
    Will your sterility test always detect contamination?

    Download
    Here
    Steritest™ Symbio Pumps

    New
    Steritest™ Symbio Pumps

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    Events

    May 31
    05/31/15 - 06/02/15
    American Society for Microbiology (ASM)
    New Orleans Ernest N. Morial Convention Center
    New Orleans, LA, USA
    ,Reagents Chemicals and Labware,Life Science Research,Industrial Biomonitoring,IVD/OEM Materials and Reagents,Analytics and Sample Preparation North America 20150531
    Jun 06
    06/06/15 - 06/09/15
    IACP Compounders on Capitol Hill
    Renaissance Washington DC
    Washington, DC, USA
    Industrial Biomonitoring North America 20150606
    Jun 09
    06/09/15 - 06/10/15
    PDA Aseptic Processing – Sterilization Conference
    Loews Coronado Bay
    San Diego, CA, USA
    Industrial Biomonitoring,Biopharmaceutical Manufacturing North America 20150609
    Jun 07
    06/07/15 - 06/10/15
    AWWA-ACE 15
    Anaheim Convention Center
    Anaheim, CA, USA
    Reagents Chemicals and Labware,Analytics and Sample Preparation North America 20150607
    Jun 10
    06/10/15 - 06/12/15
    55° SIMPOSIO AFI
    Palacongressi Della Riviera | Ingresso B | Via della Fiera, 23
    Rimini (Italia), Italy
    ,Small Molecule Pharmaceuticals,Reagents Chemicals and Labware,Life Science Research,Industrial Biomonitoring,IVD/OEM Materials and Reagents,Biopharmaceutical Manufacturing,Analytics and Sample Preparation Europe 20150610