HardyVal™ CSP Employee Validation Media-Fill Challenge Kits
Details
Hardy Diagnostics HardyVal™ CSP Employee Validation Media-Fill Challenge Kits are single-use testing systems designed to evaluate the aseptic technique of personnel who prepare compounded sterile preparations. Available in four challenge configurations, the kits feature Tryptic Soy Broth and procedure-specific vials or IV bags for simulating common sterile-compounding manipulations and detecting potential contamination through visible microbial growth or turbidity after incubation.
Material/Structure
- Single-use Tryptic Soy Broth media-fill challenge kits
- Tryptic Soy Broth formulated according to the USP Soybean-Casein Digest Broth formula
- Final prepared-media pH: 7.3 ± 0.2 at 25°C
- Recommended storage temperature: 2°C to 25°C
- Protect from direct light, excessive heat, moisture, and freezing
- Available configurations:
- HVL1 Low-Risk Challenge Kit: one 100 mL TSB serum vial, three sterile empty 20 mL serum vials, one Whirl-Pak® bag, and one results log sheet
- HVM1 Medium-Risk Comprehensive Challenge Kit with IV Bags: one 1,000 mL dual-port TSB bag with a 700 mL fill, six sterile empty 100 mL dual-port bags, six sterile empty 20 mL serum vials, one Whirl-Pak® bag, and one results log sheet
- HVM2 Medium-Risk Basic Challenge Kit with Vials: three 50 mL TSB serum vials, six sterile empty 50 mL serum vials, three sterile empty 20 mL serum vials, one Whirl-Pak® bag, and one results log sheet
- HVH1 High-Risk Challenge Kit: one 125 mL polycarbonate bottle containing 3 g of non-sterile TSB powder, nine sterile empty 20 mL serum vials, one Whirl-Pak® bag, and one results log sheet
- Syringes, needles, filters, adhesive seals, incubators, and other procedural supplies not included
- Component sterility varies by configuration; HVH1 intentionally includes non-sterile TSB powder for filtration-based challenge testing
- Sterility: Sterility varies by configuration; sterile components are included where specified, while the High-Risk kit contains non-sterile TSB powder for aseptic reconstitution.
- Sterile: HVL1 Low Risk, HVM1 Medium Risk, and HVM2 Medium Risk
- Non-Sterile: HVH1 High Risk
Cleanroom Environment
- Designed for media-fill evaluation of personnel performing aseptic manipulations during sterile compounding.
- Manufacturer procedures direct applicable manipulations to be performed within an ISO Class 5 environment.
- Challenge procedures can be adapted to reflect the facility’s routine compounding activities, equipment, and standard operating procedures.
- Completed media-fill units are incubated and examined for visible microbial growth or turbidity.
- No growth or turbidity during the specified incubation period indicates successful completion of the media-fill challenge.
- Visible growth or turbidity indicates a failed challenge and a potential breach in aseptic technique.
- The Low-, Medium-, and High-Risk designations are Hardy Diagnostics product-configuration names based on earlier USP <797> terminology; facilities should align challenge design and testing frequency with the current USP <797> requirements and their approved procedures.
Benefits
- Provides multiple challenge configurations for different sterile-compounding processes and complexity levels.
- Tryptic Soy Broth supports the growth of a broad range of bacteria and fungi introduced during an unsuccessful media-fill procedure.
- Procedure-specific bags and vials allow facilities to simulate common transfer, pooling, filtration, and filling activities.
- Single-use kits provide the core media and containers needed for one employee challenge.
- Included Whirl-Pak® bag supports transport of completed test containers to the incubator.
- Included results log supports documentation of employee, evaluator, incubation, and final test results.
- Four configurations allow facilities to select a challenge that more closely represents the manipulations performed by their personnel.
Applications
- Aseptic technique evaluation
- Sterile-compounding personnel qualification
- Media-fill challenge testing
- Initial employee competency assessment
- Ongoing personnel requalification
- Compounding pharmacy quality-assurance programs
- Hospital and health-system pharmacies
- Cleanroom and controlled-environment training
- Simulation of vial, IV-bag, transfer, and filtration procedures
Packaging
Kit: 1 Unit per Kit
Total: 1 HardyVal™ CSP Employee Validation Media-Fill Challenge Kit