Products Services Ordering Support Product Support About Us Careers Contact Us Pharmaceutical Microbiology Pharmaceutical Microbiology Your Compliance Partners in Microbiology. Media Fill Challenge Testing Environmental Monitoring of the Air Environmental Monitoring of Surfaces and Personnel Membrane Filtration/Direct Inoculation Per USP <71> Media Fill Testing Compliance was never so easy According to USP <797>: “All compounding personnel must perform media-fill testing to assess their sterile technique and related practices initially and every 6 months after.” USP <797> states, in part: “When performing a media-fill test, simulate the most difficult and challenging compounding procedures and processing conditions encountered by the person, replacing all the components used in the CSPs with soybean -casein digest media.” Low Complexity: The Low Complexity Kit by Hardy Diagnostics is recommended for simulating manipulations, involving vials and transfers, and for verifying aseptic technique. Kit performs one complete aseptic technique verification challenge test for one technician. Includes test results log sheet. The product is quality control tested for growth promotion, pH, and sterility. Medium Basic: The Medium Complexity Level Kit- Basic by Hardy Diagnostics is recommended for simulating compounding manipulations, and for verifying of aseptic transfer techniques of multiple solutions. Kit performs one complete aseptic technique verification challenge test for one technician. Includes test results log sheet. The product is quality control tested for growth promotion, pH, and sterility. Medium Comprehensive: Hardy Diagnostics Medium Complexity Level Kit-Comprehensive is recommended for simulating compounding manipulations involving the preparation of IV Bags, and for verifying aseptic technique. Kit performs one complete aseptic technique verification challenge test for one technician. Includes test results log sheet. The product is quality control tested for growth promotion, pH, and sterility. High Complexity: The High Complexity Level Kit by Hardy Diagnostics is recommended for simulating compounding manipulations and for verifying aseptic techniques of non-sterile to sterile solutions. Kit performs one complete aseptic technique verification challenge test for one technician. Includes test results log sheet. Product is quality control tested for growth promotion and pH. HVMTK: Hardy Diagnostics HardyVal™ MTK (Multiple Technician Verification Kit) is recommended for simulating compounding manipulations involving vials, ampoules and bags,and for verifying aseptic technique within a sterile compounding pharmacy facility or other cleanroom application. Each kit contains enough media to perform aseptic technique verification for up to five technicians. Product is quality control tested for growth promotion, pH, and sterility. Learn More about HardyVal Media Fill Test Kits For media fill challenge testing customization HardyVAL a la carte products make it easy to customize media fill challenge tests to your unique specifications. A la Carte components come in an array of unique formats such as vials, bags, ampoules, and tubes. All HardyVAL components are manufactured in an ISO 13485 certified GMP facility. Culture media is quality control tested for growth promotion, pH, and sterility. Learn More about HardyVal a la carte Components For media fill challenge testing of aseptic technique Media Bag™ by Hardy Diagnostics is ideal for verifying aseptic technique of pharmacists, nurses, or pharmaceutical manufacturing technicians. Available in both 100ml fills as well as larger 700ml fill bags. Media Bag™ has both a needle-port and spike port, is terminally autoclaved for high sterility assurance, and features a suspension port on the top allowing the technician to hang the bag. Learn More about Media Bag ™ Air Monitoring The Next Generation of Air Samplers. Available with one, two, or three aspirating heads. The Trio Bas Trio (three heads) has the ability to sample before, during, and after operations. Battery life lasts up to 15 hours on a single charge. Ergonomic – balanced, light weight, easy-to-hold and use. Aspirating head with quick bayonet fixing system for easy manipulation. Delayed and remote start capabilities Available in 100 or 200 liter per minute flow rate models, and contact plate or mono plate formats. No plugs or external connections* – reduce the risk of contamination. *The Mini utilizes a wall charger and data transfer cable formats. Learn More about TRIO.BAS Air Samplers Environmental Monitoring Added measure to ensure sterility in your environmental monitoring program! Tryptic Soy Agar (TSA) with Lecithin and Tween®, USP is recommended for use as a general growth medium for establishing microbiological trends, alerts and action levels in biologically controlled environments. Lok-Tight™ Contact Media Plates features a friction lid design that keeps the lid in place as well as an optional locking feature, and molded grid on the bottom of the plate to aid in the counting of microorganisms. Learn More about Lok-Tight™ Contact Plates Membrane Filtration and Direct Inoculation per USP <71> The newest generation of the Sterisart® Universal Pump – an intelligent concept for reliable results Designed for sterility sampling. Acting as a sterile barrier, the Sterisart® Septum allows for a safe, aseptic sample transfer out of a closed, sterile system. This enables you to take samples whenever needed or to transfer samples into a rapid detection system after only a few days of incubation- secure and flexible method. Learn More about the Sterisart® Universal Pump System Bottle Media with Septum Drug solutions can be tested for sterility by direct inoculation into Tryptic Soy Broth (TSB) and Fluid Thioglycollate according to USP <71>. By incubating for 14 days, a lack of fungal, aerobic, and anaerobic bacterial contamination can be proven. Please consult USP <71> (Table II) to verify proper inoculum size and media volume. Learn More about the HardyVal Direct Inoculation Broths Bring media into a controlled area while avoiding outside contamination. The ReadyRack™ is a plastic rack designed for cleanroom use and can be rinsed with alcohol. The ReadyRack™ comes filled with 80 tubes of Tryptic Soy Broth (TSB), USP or Fluid Thioglycollate Medium (FTM), USP. Simply remove ReadyRack™ from the box outside of cleanroom. Take into cleanroom and remove the plastic bag. Spray down entire ReadyRack™ with isopropyl alcohol, and allow to dry. Holes in the bottom of the rack allow for sterilant to drain. Convenient hand-holds to easily transport product. No cardboard for low particle counts. Learn More about the ReadyRack™ system Featured Catalogs View in Full Screen HardyVal™ A La Carte HardyVal™ Tryptic Soy Broth is recommended for use as a general purpose medium for the isolation and cultivation of a wide variety of bacteria and fungi. The U.S. Pharmacopeia National Formulary (USP) describes its use for sterility testing. Read More USP <800> HazDetect™ Kit Assists in hazardous drug handling competency training and can be used to simulate spills and subsequent clean-up processes. Design a training method to reflect your most risk-associated process. The recommended manipulation involves reconstituting the fluorescein powder filled (50mg septum vials) and transferring contents to a minibag, and transferring the liquid fluorescein (3ml septum tube) contents to a minibag, performing the process in conjunction with negative pressure technique to minimize the escape of liquid from the vial/tube. Read More Trio Bas™ Air Samplers Hardy Diagnostics is the sole North American distributor of the Orum TRIO BAS Microbial Air Samplers. To better service our customers, Hardy Diagnostics now offers complete calibration and repair services for the TRIO BAS air samplers. Read More Products Online Store Product Literature Product Videos Featured Products Product Support ATCC Registration Certificate of Analysis Search ISO 13485 Certification Reagent Water Test Results Scientific Posters Product FAQ’s Ordering Support Ordering Information Terms and Conditions Ordering FAQ’s International Marketplace International Terms and Conditions About Us Company Profile Our Team 100% Employee Owned Customer Testimonials Our Values Green Efforts Charitable Donations MicroBytes Newsletter Career Listing Contact Us Industry Clinical Microbiology Pharmaceutical Microbiology Food and Beverage Microbiology Copyright © 2021 Hardy Diagnostics