HardyValTM CSP Medium-Risk Level Media-Fill Challenge Test Kits

Sep 30, 2026

Hardy Diagnostics HardyValTM CSP medium-risk level media-fill challenge test kits support annual proficiency testing of aseptic procedures used for Compounding Sterile Preparations (CSPs) in line with USP Chapter <797>. The kits provide defined sterile components and media-fill materials, including Tryptic Soy Broth (TSB) with dual-port bags or serum vials, plus results logging forms. The document summarizes USP <797> risk levels, timing for compliance, and contrasts low versus medium risk activities and controls, emphasizing quality assurance monitoring frequency and environmental requirements.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages11

Reading Time28 min

AccessFree to download

Intended Use

Summary

HardyValTM Kit Formats and Components

USP <797> Risk Levels Overview

Low-Risk Level

Medium-Risk Level

HardyValTM CSP MEDIUM-RISK LEVEL MEDIA-FILL CHALLENGE KITS [Cat. no. HVM1](Cat. no. HVM1) Medium-Risk Level Media-Fill Comprehensive Challenge Test Kit-Bag Single-Use Kit Each kit contains: Tryptic Soy Broth (TSB), 1000ml Dual Port Bag, 700ml Sterile 100ml Dual Port Bags (empty) Sterile 20ml Serum Vials (empty) Whirl-Pak􀂣 Bag Results Log Sheet 1 bag 6 bags 6 vials 1 bag 1 sheet [Cat. no. HVM2](Cat. no. HVM2) [Cat. no. HVB5](Cat. no. HVB5) Medium-Risk Level Media-Fill Basic Challenge Test KitVials Tryptic Soy Broth (TSB), 50ml Serum Vial, 50ml Sterile 50ml Serum Vials (empty) Sterile 20ml Serum Vials (empty) Whirl-Pak􀂣 Bag Results Log Sheet Tryptic Soy Broth (TSB), USP, 1L IV Bag, 700ml Single-Use Kit 3 vials 6 vials 3 vials 1 bag 1 sheet 5 bags INTENDED USE Hardy Diagnostics HardyValTM CSP Medium-Risk Level Media-Fill Challenge Test Kits are recommended for routine use in the monitoring of proficiency testing and aseptic procedures used in Compounding Sterile Preparations (CSPs). Each kit contains the necessary materials for one pharmacist or technician to perform the annual medium-risk level media-fill challenge testing as specified in USP Chapter <797> . This product is not intended to be used for the diagnosis of human disease. SUMMARY On January 1, 2004 Chapter <797>, of the United States Pharmacopeia/National Formulary (USP27/NF22) entitled "Pharmaceutical Compounding Sterile Preparations", became effective. USP Chapter <797> details the procedures and requirements for compounding sterile preparations and sets standards that are applicable to all practice settings in which sterile preparations are compounded. Since USP Chapter <797> is considered a requirement, pharmacies may be subject to inspection for compliance with these standards by State Boards of Pharmacy, the FDA, and accreditation organizations, such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Accreditation Commission for Health Care, Inc. (ACHA) and the Community Health Accreditation Program (CHAP) . Compliance with these standards was required by January 1, 2006. USP Chapter <797> defines three levels of risk related to sterile preparation and includes quality assurance requirements for each risk level. These risk levels are based on the potential for introducing sources of contamination to the preparations from microbial, chemical or physical contamination during compounding activities, or in the case of high-risk compounding, that the product would remain contaminated. USP Chapter <797> provides general guidance on risk level assignment based upon compounding manipulations, types of ingredients and equipment used, compounding environment, and storage and use of the resulting preparation. A summary table of risk levels is included below however, regardless of the examples provided, the ultimate determination of risk level is the responsibility of the licensed health care professionals who supervise compounding, using their professional judgement and experience. The HardyVal™ CSP Medium-Risk Level Media-Fill Challenge Test Kit is available in two formats: The Comprehensive Challenge Test Kit (with IV bags) and the Basic Challenge Test Kit (without IV bags, with serum vials only). The HardyVal™ Tryptic Soy Broth (TSB), USP one liter IV bag is also available as a standalone component. | Risk Level | Description | Examples | QA Monitoring and Frequency | | --- | --- | --- | --- | | Low | • Involves only transfer, measuring and mixing with closed or sealed packaging systems.
• Limited to aseptically opening ampules, penetrating sterile stoppers on vials with sterile needles or syringes, transferring sterile liquids in sterile syringes to sterile administration devices.
• Prepared entirely in an ISO Class 5 (see below) or better air quality environment.
• In the absence of passing a sterility test, storage for a maximum of 48 hours at room temperature,

FAQs

What is the intended use of HardyValTM CSP Medium-Risk Level Media-Fill Challenge Test Kits?

They are recommended for routine use in monitoring proficiency testing and aseptic procedures for Compounding Sterile Preparations (CSPs), as specified in USP Chapter <797>. They are not intended for diagnosing human disease.

What materials are included in the kits?

The document lists Tryptic Soy Broth (TSB) with dual-port bags or serum vials, sterile serum vials (empty), Whirl-Pak bags, and results log sheets, with quantities varying by kit format.

What does USP Chapter <797> define for risk levels?

It defines three sterile preparation risk levels and quality assurance requirements for each. Risk assignment depends on potential contamination sources during compounding and the compounding environment and practices, with final determination by licensed healthcare professionals.

Sep 30, 2026

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