USP <797>

USP General Chapter <797> sets the minimum standards for any person who compounds a Compounded Sterile Preparation (CSP) — a sterile dosage form prepared in a pharmacy, hospital, infusion suite or 503A compounding facility. It covers the physical environment (air classification, pressure cascade), the people (garbing, hand hygiene, competency), the process (categorisation by complexity and beyond-use date), the materials (sterile vs non-sterile ingredients, source containers), and the verification (environmental monitoring, sterility testing where required).

The 2023 revision (effective 1 November 2023) replaced the previous Category 1 / Category 2 / Category 3 structure with a more risk-stratified scheme, tightened beyond-use-date (BUD) tables, made hand hygiene + garbing more explicit, formalised the Designated Person (DP) role, and removed the long-standing 'Low / Medium / High Risk' language. Sites that did not migrate by November 2023 are operating off an obsolete standard.

The Primary Engineering Control (PEC) is the device that achieves ISO Class 5 air at the point of compounding — a Laminar Airflow Workbench (LAFW), Biological Safety Cabinet (BSC), Compounding Aseptic Isolator (CAI) or Compounding Aseptic Containment Isolator (CACI). The Secondary Engineering Control (SEC) is the room containing the PEC — for Category 2 compounding it must be a cleanroom suite consisting of an ISO 7 buffer room and an ISO 8 (or better) ante-room with a positive pressure cascade from buffer to ante to corridor (negative cascade for hazardous-drug rooms under <800>).

Category 1 compounding (the simpler category, with shorter BUDs) may be done in a Segregated Compounding Area (SCA) — a designated space containing an ISO 5 PEC without the surrounding ISO 7 cleanroom. The BUD trade-off is severe: Category 1 CSPs prepared in an SCA are limited to 12 hours at controlled room temperature or 24 hours refrigerated; Category 2 in a full cleanroom suite can extend to days or weeks depending on sterility testing.

The post-2023 chapter recognises three categories of CSP. Category 1: prepared in an SCA or full cleanroom suite, sterility testing optional, very short BUD. Category 2: prepared in a full cleanroom suite, sterility testing not required if BUD ≤ the limits in Table 11, longer BUDs allowed. Category 3: prepared in a full cleanroom suite under additional controls (sterility testing required per <71>, endotoxin testing where applicable, validated extended garbing) — supports the longest BUDs, intended for batches and complex preparations.

Garbing order matters. The chapter prescribes the sequence: remove outer garments and visible jewellery, don shoe covers, hair cover, beard cover (if applicable), face mask; perform hand hygiene (vigorous wash with soap and water to elbows, dry with low-lint towels); don non-shedding gown; perform sterile-glove-compatible hand sanitisation (alcohol-based, allowed to dry); don sterile gloves; sanitise gloves with sterile 70 % IPA on entry to the PEC and at any point of suspected contamination thereafter.

Competency is verified by Gloved Fingertip and Thumb Sampling (GFS) and Media-Fill Testing (MFT). Initial qualification requires three consecutive successful gloved-fingertip samples after garbing (zero CFU on each hand) before media fill, plus a media fill (a complete simulated compounding run using TSB or another growth medium instead of drug) with zero contaminated units. Requalification: gloved fingertip after each media fill, and media fill every six months for Category 1/2 and every three months for Category 3.

<797> requires a written EM programme: viable air sampling in the PEC and SEC at least every 6 months (every month for Category 3), surface sampling of all classified surfaces at least every month, non-viable particle counts in the PEC and SEC at least every 6 months, and pressure differential monitoring continuously with daily review. Action levels: PEC (ISO 5) >1 CFU viable air or surface triggers investigation; ISO 7 buffer >10 CFU air / >5 CFU surface; ISO 8 ante >100 CFU air / >50 CFU surface.

Identification of recovered organisms to at least genus level is required for any excursion. Recovery of objectionable organisms (Gram-negatives, moulds, spore-formers) at any level triggers immediate investigation, source identification, corrective action and possibly product recall consideration for CSPs made during the affected window.

The 2023 revision formalised the Designated Person (DP) — an individual identified by name in the SOPs as responsible for oversight of the compounding facility, training competency, SOP currency, EM programme, BUD assignment, recall response and corrective action. The DP role can be delegated for specific tasks but the named individual retains accountability. Inspectors ask for the DP by name and review the DP's qualification and training records.

1. BUD assigned beyond the testing-free limit without sterility testing on file.
2. Garbing sequence performed incorrectly — hand hygiene before gowning, or alcohol-glove sanitisation skipped.
3. Gloved fingertip and media-fill competencies expired — operators continued to compound past the requalification date.
4. EM excursion (ISO 5 fingerprint plate recovered 2 CFU) closed without organism ID and without root-cause analysis.
5. Pressure cascade failure (buffer to ante < 0.020 in. wc) not investigated because no one was reviewing daily logs.
6. Sterile 70 % IPA used past its labelled expiry, or stored in a non-sterile container after first opening.
7. SOPs last reviewed > 2 years ago — not updated to the 2023 chapter revision (still using Low/Medium/High Risk language).
8. Designated Person named in SOP but has no documented qualification or oversight activity.

• Each CSP recipe carries its category (1/2/3), the assigned BUD and the sterility-testing rule for that BUD — release is blocked if a CSP claims an extended BUD without a passing <71> result on file.
• Operator competency file holds gloved-fingertip results, media-fill results and expiry dates; an expired competency blocks the kiosk from letting the operator start a CSP.
• EM schedule auto-generates pulls by location (PEC, SEC, ante) at the chapter-mandated frequency; missed pulls open a deviation automatically.
• Garbing checklist is a kiosk-enforced step before PEC entry; sterile-IPA expiry is tracked at the container level.
• Pressure-differential telemetry from the cleanroom BMS streams into V5 — out-of-range opens a deviation, freezes the affected CSP batch and prompts an investigation against the actual chapter limit.
• Designated Person is a named role on the org chart with electronic ownership of EM review, recall response and SOP currency — audits show the named individual's signature, not a queue.