Category 1 CSP Media-Fill Test Kit

USP <797> Category 1 aseptic competency—comprehensive on core manipulations and built for repeatability. Each technician completes three sets in one session using defined vial-to-vial transfers; each set concludes with a result vial for incubation. The format increases measured transfer count and process duration, mirroring USP <797> focus on number of transfers and process complexity—delivering consistent, comparable readouts with minimal setup.

IVQA media-fill test kits pair a comprehensive, transfer-dense design with illustrated, easy-to-follow Instructions for Use and an audit-ready log sheet—simplifying training and documentation. Every kit includes a Certificate of Analysis, and each lot is tested for growth promotion and sterility for dependable performance, cycle after cycle. Components arrive organized in a cleanroom-friendly thermoformed clamshell, ready to use on arrival. Use one kit per technician for onboarding and every 6 months (Category 1 & 2) or every 3 months (Category 3) thereafter. Trusted by compounding and hospital pharmacies, health-system cleanrooms, home-infusion providers, oncology/infusion centers, outsourcing facilities, and academic medical centers.

• • Instructions For Use
  • Category 1 CSP Log Sheet
  • Certificate of Analysis Search

Test Procedure:

Once the test is initiated:

• Must be carried out to completion without interruptions.
• Performance conditions should mimic the usual work environment.

USP Chapter <797> Category 1 CSP Guidelines

Description:

• • Verifies aseptic techniques for preparations with a Beyond-Use Date (BUD) of 12 hours or less at controlled room temperature or 24 hours or less when refrigerated.
  • Applicable for simple aseptic manipulations typically in less controlled environmental conditions.
  • Ideal for verifying technique in single transfers from ampules or vials, straightforward reconstitutions, or dilutions.
  • All compounding activities must be performed in an ISO Class 5 or better air quality environment to minimize the risk of contamination.

Examples:

• • Transferring a medication from a single-dose vial to a syringe for immediate administration.
  • Mixing a powdered medication with a sterile diluent in a single vial.
  • Opening an ampule and transferring its contents to a syringe or a sterile container for immediate use.
  • Adding a single medication to an IV bag using aseptic techniques.
  • Drawing up medications into syringes for immediate administration to a patient.
  • Mixing two sterile products in a single container when the procedure is straightforward and quick.

Initial Training and Competency:

• • Before beginning independent compounding or having direct oversight of compounding personnel, individuals must successfully complete an initial aseptic manipulation competency evaluation.
  • This initial evaluation includes visual observation, media-fill testing, gloved fingertip and thumb sampling on both hands, and surface sampling of the direct compounding area.

Frequency of Ongoing Competency Testing:

• • Aseptic manipulation competency evaluations must occur at least every 6 months for personnel compounding Category 1 CSPs.

References:

• • USP Chapter <797> guidelines can be found in the current version of the United States Pharmacopeia and National Formulary (USP–NF), which outlines the standards for sterile compounding procedures and quality assurance practices.
  • Whirl-Pak® is a registered trademark of Nasco International, Inc.