USP <797> SAMPLE ANALYSIS
Built for the 2023 USP <797> Revision.
Sample culture and analysis that helps compounding pharmacies, hospitals, and healthcare providers maintain USP <797> compliance and protect patient safety. You collect the samples; our ISO/IEC 17025:2017 lab handles the analysis and reporting.
What Is USP <797>?
USP <797> is the chapter of the United States Pharmacopeia that defines the standards for safely preparing compounded sterile preparations (CSPs). The chapter covers personnel training, environmental monitoring, quality control, documentation, and beyond-use date (BUD) determinations, covering every touch-point that affects whether a CSP reaches the patient contamination-free.
Healthcare facilities that adhere to USP <797> reduce the risk of microbial contamination, protect patient safety, and preserve the potency of compounded medications. The latest revision became official on November 1, 2023 and further tightens the requirements for environmental monitoring frequency, viable sampling locations, and personnel competency.
Our lab supports your facility's monitoring program with the analysis pieces of the puzzle. Your team performs the sampling on-site; we incubate, identify, count, and report, with results aligned to the action levels your QA program expects.
Sample Types We Analyze
Click each sample type to expand its details.
Bacterial and fungal counts identified to genus level using TSA and SabDex contact plates. Risk-based sampling of classified areas, ISO Class 5 PEC chambers, and pass-through connections, at minimum monthly for Category 1 and 2 CSP entities.
Bacterial and fungal air analysis using TSA and SabDex petri plates. The 2023 revision increases the number of sampling locations and requires fungal incubation with cooling-capable equipment, both of which we support in our lab workflow.
Direct assessment of garbing effectiveness. Personnel press gloved fingertips and thumbs onto sterile TSA plates; we incubate and report bacterial and fungal counts to verify aseptic technique.
Process simulation analysis using microbial growth medium in place of actual drug ingredients. Verifies aseptic technique and surfaces process concerns. Complete kits available with sterile bags, vials, tryptic soy broth, and syringes.
Combined evaluation of surface, air, gloved fingertip, and media fill components for personnel. Required for initial qualification and at the cadence USP <797> specifies for each CSP category.
Analysis services that support cleanroom certification programs and facility qualification, including biosafety cabinets, fume hoods, laminar flow hoods, and compounding isolators.
Environmental verification analysis to validate cleanroom performance and ongoing USP <797> compliance.
USP <797> Action Levels at a Glance
Our reports compare your sample results against the published action levels so your QA team can act quickly when a result drifts out of range.
Viable Air (cfu/m³ per 1000 L per device)
- ISO Class 5: > 1
- ISO Class 7: > 10
- ISO Class 8: > 100
Viable Surface (cfu per media device)
- ISO Class 5: > 3
- ISO Class 7: > 5
- ISO Class 8: > 50
Gloved Fingertip (cfu, total from both hands)
- After garbing: > 0
- After media-fill: > 3
Sample Matrix and Supplies
| Matrix | Lab Analysis | Sampling Media / Supplies |
|---|---|---|
| Air | Bacterial & fungal recovery, identified to genus level | TSA petri or contact plates; SabDex petri or contact plates |
| Surface | Bacterial & fungal recovery, identified to genus level | TSA contact plates, 15x65mm; SabDex contact plates, 15x65mm |
| Gloved Fingertip | Bacterial & fungal recovery with CFU counts | TSA petri plates, 15x100mm |
| Media Fill | Sterility readout for process simulation units | Empty sterile bags & vials, sterile tryptic soy broth, syringes |
How Often Do You Need to Sample?
The 2023 revision of USP <797> increased frequency requirements for both environmental sampling and personnel evaluation. The right cadence depends on your CSP category and your facility's standard operating procedures, but the baseline expectations are:
- Categories 1 & 2: All classified areas sampled at least monthly; aseptic competency re-evaluated at least every six months.
- Category 3: Aseptic competency re-evaluated at least every three months.
- All categories: Personnel overseeing compounding require annual competency evaluation.
Why Choose Air Allergen for USP <797> Lab Services?
- ISO/IEC 17025:2017 accredited laboratory with consistent, defensible reporting
- Quick turnaround on every sample type so QA can act inside the response window
- Configurable subscription kits with all media and supplies for surface, gloved fingertip, and media-fill sampling
- Competitive per-sample pricing with no minimums
- Reports referenced against USP <797> action levels so out-of-range results surface immediately
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