HardyVal™ Tryptic Soy Broth (TSB), Glass Serum Vial with Needle-Port Septum, 15mL
Details
Hardy Diagnostics U382 HardyVal™ Tryptic Soy Broth (TSB) is a sterile, ready-to-use culture medium supplied as a 15 mL fill in a 20 mL glass serum vial for media-fill challenge testing and routine monitoring of aseptic procedures used to prepare Compounded Sterile Preparations (CSPs). Featuring a needle-port septum for aseptic transfer simulations, this HardyVal™ à la carte component allows facilities to create customized proficiency tests that resemble their routine compounding procedures.
Material/Structure
- Prepared liquid culture medium
- Container: 20 mL glass serum vial
- Closure: Needle-port septum
- Fill volume: 15 mL
- Clear, light amber appearance
- Sterile
Formulation
- Tryptic Soy Broth, also known as Soybean-Casein Digest Broth
- Formulated in accordance with USP <797> for media-fill challenge applications
- Contains pancreatic digest of casein, papaic digest of soybean meal, sodium chloride, dextrose, and dipotassium phosphate
- Formula per liter: 17.0 g pancreatic digest of casein, 5.0 g sodium chloride, 3.0 g papaic digest of soybean meal, 2.5 g dextrose, and 2.5 g dipotassium phosphate
- Final pH: 7.3 ± 0.2 at 25°C
- Casein and soybean meal digests provide amino acids and other nitrogenous nutrients that support microbial growth.
- Dextrose provides an energy source, while dipotassium phosphate helps maintain the medium’s pH.
Cleanroom Environment
- Designed for routine monitoring of aseptic procedures used during the preparation of Compounded Sterile Preparations.
- Supports media-fill challenge testing and personnel aseptic-technique evaluations performed under established USP <797> procedures.
- Needle-port septum supports transfer simulations without completely removing the vial closure.
- Sterile, ready-to-use format reduces preparation and handling requirements.
- HardyVal™ à la carte configuration allows facilities to create customized proficiency tests that resemble routine compounding procedures.
Benefits
- Supports the growth of a variety of bacteria and fungi that may indicate a breach in aseptic technique.
- Clear medium allows visual observation of turbidity or other evidence of microbial growth.
- Needle-port septum facilitates realistic aseptic transfer and manipulation simulations.
- 15 mL fill provides working space within the 20 mL vial for media-fill challenge procedures.
- Ready-to-use format eliminates in-house media preparation before testing.
- Can be combined with other HardyVal™ à la carte components to create customized proficiency tests.
Applications
- USP <797> media-fill challenge testing
- Aseptic-technique proficiency evaluation
- Sterile compounding personnel training
- Routine personnel competency assessments
- Monitoring aseptic procedures used to prepare CSPs
- Customized HardyVal™ process simulations
- Evaluation of potential microbial contamination introduced during simulated compounding procedures
Result Interpretation
- Visible growth or turbidity observed on or before 14 days indicates a positive result and a potential breach in aseptic technique.
- No visible growth or turbidity after 14 days indicates a negative result under the conditions of the test.
- Follow the incubation temperatures and procedures established by the facility and applicable USP <797> guidance.
Important Use Limitation
- Hardy Diagnostics states that HardyVal™ à la carte components are not adequate for USP <71> sterility-testing procedures.
- This product is intended for laboratory use and is not intended for the diagnosis of human disease.
Storage
- Store at 2°C to 25°C.
- Keep away from direct light.
- Protect from excessive heat, moisture, and freezing.
- Do not use if the medium shows contamination, deterioration, discoloration, or is beyond its expiration date.