USP <797> Media-Fill Test Kits

Comprehensive. Reliable. Repeatable.

At Intravenous Quality Assurance (IVQA), we’ve been manufacturing media-fill testing supplies for over 20 years. Our mission is to make USP <797> aseptic competency straightforward, comprehensive, and repeatable. Transfer-dense workflows with triplicate endpoints deliver clear pass/fail results, while detailed, step-by-step instructions, log sheets, and a Certificate of Analysis in every kit keep teams audit-ready across Category 1, 2, and 3 CSPs.

Comprehensive, reliable, repeatable media-fill testing that ensures your team stays inspection-ready.

Finding the right kit for your application

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Category 1 CSP

Category 1 CSPs involve basic and rapid compounding activities with minimal contamination risk, including single-dose vial transfers, straightforward reconstitution of powdered medications, ampule opening and contents transfer, simple IV admixtures, syringe preparation for immediate use, and sterile-to-sterile product mixing in cases where procedures are direct and expedient.

Vial

Category 2 CSP

Category 2 CSPs involve intermediate-level compounding tasks such as TPN compounding with precise multi-component mixing, multiple-step aseptic transfers, chemotherapy preparation with strict dosing, medication compounding for infusion pumps, batch preparations for several patients, and long-duration compounding processes, each demanding meticulous aseptic techniques to minimize contamination risks.

Form

Category 3 CSP

Category 3 CSPs require advanced aseptic techniques due to their complexity and higher contamination risks, including the use of non-sterile ingredients and exposure to suboptimal air quality. Examples include bulk compounding for extended storage, incorporating non-sterile components for customized medication formulations, and utilizing sophisticated technologies for sensitive medications, all requiring rigorous sterilization measures post-compounding.

Designing your own test procedure?
View our Design-A-Kit product line to develop testing procedures that closely match your specific operations.
Have Questions?
For inquiries about testing procedures, placing an order, or any other questions related to our products, please reach out using the contact options provided below:
Phone: (626) 629-0418
Email: support@ivqa.com
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