USP 797 repeater pump requirements are an often-overlooked part of sterile compounding compliance.
Are You Using a Repeater Pump in Your Sterile Compounding?
Don’t Overlook This USP <797> Media Fill Requirement.
Repeater pumps are a powerful tool for sterile compounding — especially when preparing multiple doses from a single source. But if you’re using a repeater pump during routine production and not including it in your media fill simulation, you could be falling short of USP <797> expectations.
Under the 2023 revision to USP <797>, sterile compounding facilities must simulate “the most challenging or stressful conditions encountered during compounding.”
That includes any equipment routinely used — such as repeater pumps.
⚠️ The Compliance Gap
We’ve recently heard from several pharmacy teams whose Board of Pharmacy inspectors flagged their competency evaluations because the repeater pump was not used during their media fill test — even though it’s used daily in production.
The problem isn’t the test kit. It’s how it’s applied.
Our Solution: Category 2 Media Fill Kit — Repeater Pump Compatible
You don’t need a special kit — just a proper procedure.
Our existing Category 2 media fill kit is fully compliant and includes:
Sterile TSB vial
Sterile syringes
Incubation and result tracking
✅ Now includes repeater pump simulation checklist
The Repeater Pump Simulation Checklist walks you step-by-step through using your pump during the test, satisfying both USP <797> and Board of Pharmacy inspections.
Understanding USP 797 Repeater Pump Requirements
The USP 797 repeater pump requirements were clarified in the 2023 revision to ensure that pharmacies using automation in sterile compounding accurately simulate real-world conditions. A repeater pump isn’t exempt from validation just because it’s mechanical — it’s an extension of the operator. Every step that involves the pump during daily sterile compounding must be represented in the media fill and competency assessment.
When inspectors review your training or audit records, they expect to see documentation showing that the repeater pump was tested under aseptic conditions. This ensures your personnel can safely operate the pump, maintain positive aseptic technique, and prevent contamination from repetitive fluid transfers.
⚠️ Common Compliance Gaps
Even experienced pharmacies sometimes miss the connection between routine equipment and media fill simulations. Common findings include:
Media fills performed manually, while production uses a repeater pump.
Lack of documented aseptic qualification for the pump.
Repeater pump tubing and reservoir not handled under ISO Class 5 conditions.
Missing documentation proving that pump use was part of the Category 2 media fill.
Any of these oversights can trigger a citation under USP 797 Section 13.3 “Verification of Aseptic Operations.”
How to Ensure Compliance
To meet USP 797 repeater pump compliance standards:
Use your repeater pump during the entire media fill simulation exactly as it’s used in production.
Disinfect and set up the pump within your ISO 5 PEC or isolator.
Run the test through a complete fill cycle, using sterile TSB vials or bags.
Record the pump ID, operator initials, and batch date on your competency form.
Retain results for at least 3 years per your facility policy.
By documenting this process, your team demonstrates that you’ve validated the most challenging conditions of your workflow — a key requirement of USP 797 and most Board of Pharmacy inspectors.
Why It Matters
Including your repeater pump in media fill simulations closes a major compliance gap and proves that your sterile compounding operation is robust, consistent, and inspector-ready. It also reinforces staff competency, reducing the risk of product contamination and failed audits.
When in doubt, treat your repeater pump as part of the compounding workflow — not an accessory. Testing it during media fill is simple, inexpensive, and required for full USP 797 compliance.
Add Confidence to Your Competency Evaluations
Whether you’re a 503A pharmacy, infusion center, or hospital sterile compounding team, our solution makes compliance simple — without changing your kit or workflow.
Want to see the checklist or try a sample kit?
Contact us
or call 800-418-9289.
Learn more about USP <797> requirements here
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Thank you, we are happy that you found our content helpful.