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.

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.

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.

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.

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.

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.

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.