Software for sterile compounding

USP General Chapter <797> Pharmaceutical Compounding — Sterile Preparations was revised with an official date of 1 November 2023. It applies to anyone preparing compounded sterile preparations (CSPs) — 503A pharmacies, hospital pharmacies, physician offices and, as a floor beneath cGMP, 503B outsourcing facilities. The chapter is enforced through state boards of pharmacy, accreditation bodies and, for 503Bs, through FDA's cGMP expectations. Its main sections cover personnel training and competency, personal hygiene and garbing, facilities and engineering controls, certification and recertification of the cleanroom, environmental monitoring (air and surface sampling), cleaning and disinfection, component handling and sterilisation, master formulation and compounding records, release inspection and testing, labeling, BUDs, quality assurance and quality control, and documentation.

The revised chapter replaced low/medium/high risk levels with three categories defined by where and how the CSP is made and whether it is sterility tested. The maximum BUDs are set by category, sterilisation method, sterility testing and storage condition. The figures below are the chapter's maxima; a shorter BUD applies if any component's expiry or stability data demands it.

In Pharmacy Flow the formulation carries the BUD you have assigned under the chapter and your stability data. Each finished lot then receives that BUD or the earliest expiry among the raw-material lots consumed, whichever is sooner. The minimum is computed in the database when the batch is created, so a lot cannot be labeled with a BUD that outlives one of its components.

The chapter sets minimum frequencies for viable air sampling, surface sampling, pressure-differential monitoring, and temperature and humidity monitoring in classified areas, and requires action levels with an investigation when they are exceeded. Pharmacy Flow's environmental monitoring module records each reading against its room and ISO class with the metric (viable particulate, non-viable at ≥ 0.5 µm and ≥ 5.0 µm, temperature, humidity, differential pressure), the value, the unit and the action limit. Status is derived, not chosen: a reading over its action limit is Action, within 10% of it is Alert, otherwise Pass. The list filters by room, metric, status and period and exports, which is what "trended" means in practice — and an Action reading links directly to the environmental deviation category so the investigation opens against the reading that triggered it.

A sterile batch is planned from an approved formulation, consumes named raw-material lots in recorded quantities, and produces a finished lot in Quarantine. The QC tests your procedure specifies — sterility, bacterial endotoxin, potency, visual inspection, pH, whatever the formulation lists — are created as Pending on the lot. The lot's transition to Available is rejected by the database unless every test is recorded as Pass and a release signature is on record; the signature itself requires the pharmacist or QA user to re-enter their password at the moment of signing. Every status change is written to the lot's history with actor and time. The mechanics are the same for a 503A pharmacy and a 503B facility; the difference is which tests your category and regulatory status require.

A BUD that is correct on the lot but ignored at the bench is worth little. Each dispensed unit carries its serial and the lot's BUD as its expiry. At the line, scanning a unit against an order checks four things before the fill is accepted: the serial exists, it belongs to this order, the unit is not under recall, and it is not past its BUD. Any failure refuses the fill with the reason. Inventory lists show lots by expiry band so short-dated lots are used first, and the putaway rule sends refrigerated lots to cold storage and frozen lots to frozen storage on receipt.

Deviations carry a category — temperature excursion, OOS result, label error, fill discrepancy, equipment, documentation, process, environmental — a severity of Critical, Major or Minor, a linked lot where relevant, and a status of Open, Investigating or Closed. A CAPA can be opened from the deviation and runs Open, In Progress, Verification, Closed, so effectiveness verification is a distinct step. Change controls cover formulation, supplier, process, equipment and document changes, each with review and approval signatures. Signature meanings are fixed (Reviewed, Approved, Released, Verified, Witnessed, Rejected) and the approvals table is append-only for application users. The Part 11 explainer describes the signature ceremony; security and compliance describes the data controls.

Where a sterile product is also hazardous under the NIOSH list — antineoplastics and a number of hormones among them — USP <800> applies on top of <797>. Materials flagged hazardous in the master data are routed to a segregated hazmat location by the putaway rule, and a hazardous packout option carries the segregation through fulfilment. The physical containment — negative-pressure C-SEC, externally vented C-PEC, closed-system transfer devices — is a facility matter; the platform's job is to make sure the hazardous lot never lands in the general bin and the record shows where it went. Our USP <800> checklist covers the programme end to end. For hormone products specifically, see hormone therapy software.

Cold-chain distribution of CSPs is its own discipline; read the cold-chain guide. For sourcing sterile components and APIs, the supplier directory and RFQ marketplace are open. For unit identifiers and trace, see serialization and DSCSA. The broader compounding platform and inventory module pages cover the rest.