Room Monitoring Checklist for Sterile Compounding
A two-page checklist of the room monitoring points inspectors look at: pressure, temperature, humidity, refrigerator and freezer storage, alarms, calibration and records. Print it, walk your rooms, and tick off what you already do.
- Pressure limits for USP <797> and <800> rooms
- Daily documentation and alarm requirements
- Refrigerator, freezer and −80°C storage
- A one-table quick reference of every target
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Seven sections you can tick off
Room pressure
Continuous monitoring, minimum differentials and daily review.
Temperature & humidity
Limits and daily checks for every classified room.
Refrigerators & freezers
Storage ranges, product-temperature probes and 24/7 alarms.
Excursions & alarms
What to record and how to prove alarms reach someone.
Devices & calibration
Accuracy checks, NIST-traceable certificates and certification.
Records & review
How long to keep records and what inspectors ask for.
Hazardous drugs
Negative-pressure rooms under USP <800>.
Made for the people who sign the logs
Pharmacists in charge, compounding supervisors and quality managers at 503A pharmacies, 503B outsourcing facilities, hospital IV rooms and infusion centers. Use it before an inspection, after a room change, or when you're choosing new monitoring equipment.