Sterile compounding under USP <797> is a discipline of controls: cleanroom environment, aseptic technique, beyond-use dating, and documentation that proves each was met. Pharmacy Flow builds those controls into the workflow so nothing depends on memory or a paper binder.
The sterile controls, enforced
- ✓Environmental monitoring — cleanroom readings, ISO-class tracking, and excursion handling
- ✓Beyond-use dating and expiry driven by product and storage
- ✓Batch records with component lot capture and reconciliation
- ✓Unit-level serialization for traceability and recall
- ✓Directed, segregated putaway and cold-chain handling
- ✓21 CFR Part 11 e-signatures on release and quality actions
Sterile work often overlaps with hazardous handling — see the USP <800> checklist — and with 503B batch manufacturing. Pharmacy Flow covers both under one compliance framework.
On inspection, sterile compounding lives or dies on documentation. When the environmental logs, BUDs, and batch records are captured automatically, you're proving compliance instead of reconstructing it.
Frequently asked questions
Does it support USP <797> environmental monitoring?+
Yes — cleanroom readings, ISO-class tracking, and excursion handling are recorded with an audit trail.
Is beyond-use dating handled?+
Yes, BUD and expiry are tracked by product and storage condition and enforced through fulfillment.