Using a repeater pump in sterile compounding can greatly improve efficiency, but it also brings specific obligations under USP 797 repeater pump compliance. Many pharmacies overlook these expectations, which can lead to citations during inspections. This guide explains everything you need to know — from pharmacy repeater pump guidelines to sterile compounding pump validation — to help your team meet the most current standards.
Why Repeater Pumps Matter in Sterile Compounding
A repeater pump sterile compounding workflow allows multiple doses to be drawn from the same sterile source with consistent accuracy. However, USP <797> requires pharmacies to validate every piece of equipment used during aseptic processing. That includes automated dispensing systems, peristaltic-style pumps, and any device used for repetitive transfers.
If your team relies on a repeater pump daily yet excludes it from your aseptic process simulation, your compounding program may not meet usp 797 repeater pump compliance expectations.
USP <797> Requirements: Don’t Skip This Media Fill Rule
The 2023 revision to USP <797> states that pharmacies must simulate “the most challenging or stressful conditions encountered during compounding.”
That means:
Any device routinely used in production
Any equipment influencing aseptic technique
Any automated dispensing pump used for dose preparation
must be included in the media fill and competency assessment.
If you use a repeater pump for sterile preparations, then repeater pump sterile compounding must be simulated in your media fill test.
Where Pharmacies Get Cited: Common Compliance Gaps
Inspectors frequently report the following issues related to pharmacy repeater pump guidelines:
1. Manual media fills while production uses a repeater pump
This breaks the chain of real-world simulation.
2. Missing sterile compounding pump validation
USP 797 expects documented validation, calibration requirements, and aseptic performance verification for the device.
3. Tubing and reservoir not handled under ISO Class 5
All components must be prepared within a PEC or isolator.
4. No proof the pump was part of the Category 2 media fill
Lack of documentation leads to Section 13.3 citations for improper verification of aseptic operations.
These issues occur even in well-run pharmacies and can trigger compliance warnings.
How to Achieve Full USP 797 Repeater Pump Compliance
To meet USP 797 repeater pump compliance, follow these steps:
1. Use the repeater pump during the entire media fill
Simulate your real production workflow — including bottle piercing, pump priming, tubing handling, and repetitive fluid transfers.
2. Perform pump validation
Document pump calibration, aseptic setup, operator technique, and contamination risk mitigation.
3. Work inside ISO Class 5 air
Set up the pump, tubing, and TSB vials inside the PEC to maintain workflow integrity.
4. Complete full aseptic process simulation
Run the pump through a complete fill cycle using sterile TSB vials or bags to verify compounding accuracy.
5. Document quality assurance
Record batch date, operator ID, settings, and process steps. Retain results for at least 3 years.
This satisfies both USP <797> and most Board of Pharmacy expectations.
Our Solution: Repeater Pump-Compatible Category 2 Media Fill Kit
You do not need a custom kit.
You simply need the correct procedure.
Our Category 2 media fill kit includes:
Sterile TSB vial
Sterile syringes
Incubation and result tracking
simulation checklist
Step-by-step aseptic workflow instructions
The checklist guides your team through proper aseptic setup, tubing management, operator technique, and full workflow simulation — ensuring complete compounding validation.
Why This Matters for Patient Safety and Inspection Success
Repeater pumps play a critical role in contamination control, dosing accuracy, and aseptic workflow consistency. Including the pump in your media fill:
Demonstrates accurate simulation of routine conditions
Strengthens operator proficiency in aseptic technique
Reduces contamination risk
Shows inspectors you’ve validated the most challenging steps
Makes your program compliant with guidelines
When in doubt, treat the repeater pump as an integral part of your sterile compounding workflow — because under USP 797, it absolutely is.
Add Confidence to Your Competency Evaluations
Whether your team operates a 503A pharmacy, infusion center, or hospital sterile compounding suite, proper validation is essential. Our kit and checklist make compliance straightforward, efficient, and inspection-ready.
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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