- Condition: Factory New
- Weight: 2.36 lb
- Quality culture media tested for performance, pH and sterility.
- Kits are designed to help you follow USP <797> guidelines.
- Kit performs one complete aseptic technique verification challenge test for one technician.
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Learn more:
- MFR: Hardy Diagnostics Ships from MFI Medical
- MPN: HVM2
Frequently asked questions
Does this kit help maintain USP <797> compliance?
Yes, the HardyVal CSP Medium Complexity Kit is specifically designed to assist healthcare and laboratory facilities in meeting the rigorous requirements of USP <797> regarding sterile preparations.
Is the Tryptic Soy Broth quality-tested?
Absolutely. The included culture media undergo rigorous testing for: - Performance accuracy - Correct pH levels - Guaranteed sterility for reliable results.
How many technicians can one kit test?
This kit is designed for a single-technician aseptic technique challenge, providing a comprehensive verification for one person per test.
What specifically is included in the package?
The kit is a complete set featuring: - 3 Vials of 50 mL Tryptic Soy Broth (TSB) - 6 Sterile 50 mL empty serum vials - 3 Sterile 20 mL empty serum vials - 1 Whirl-Pak bag - 1 Results log sheet for documentation.
Is this suitable for testing medium-risk compounding?
Yes, it is perfectly tailored for medium-risk level compounding manipulations. It allows you to simulate complex transfers to validate that personnel are proficient in aseptic techniques.
Are the testing materials BAA and TAA compliant?
Yes, this kit is both Buy American Act (BAA) Compliant and Trade Agreement Act (TAA) Compliant, ensuring it meets high standards for domestic manufacturing.
Is the result reading process straightforward?
Yes, the kit utilizes a Visual Read format. This makes it efficient for microbiology quality control staff to assess aseptic skills without requiring complex instrumentation.
Is this kit classified under CLIA regulations?
No, the HardyVal CSP Medium Complexity Kit is categorized as Non-Regulated under CLIA classification, simplifying its integration into your laboratory’s existing quality control workflows.
Does the kit come with a way to record results?
Yes, every kit includes a Results Log Sheet specifically formatted to help you document the challenge results effectively for your records and compliance audits.
What is the primary benefit of the aseptic challenge?
The primary benefit is professional verification. By simulating real-world compounding tasks, you ensure that your staff is truly proficient in handling medium-risk sterile transfers, ultimately enhancing safety and procedural consistency.