USP <797> Environmental Monitoring Lab Analysis
Comprehensive laboratory analysis services that help compounding pharmacies, hospitals, and healthcare providers maintain USP <797> compliance and protect patient safety. We analyze the samples you collect — your facility stays in control of the sampling process.
What Is USP <797>?
USP <797> is a chapter of the United States Pharmacopeia that establishes minimum standards for the preparation, handling, and storage of compounded sterile preparations (CSPs). It covers personnel training, garbing, environmental monitoring, equipment qualification, quality assurance, and documentation — every link in the chain that keeps a CSP free of microbial, chemical, and physical contamination.
The revised chapter became official on November 1, 2023, introducing tighter expectations around environmental monitoring frequency, sampling locations, fungal incubation, and personnel competency. Facilities that adhere to these standards reduce contamination risk, preserve drug potency, and protect the patients who receive compounded medications.
Our role is on the laboratory side. Your facility (or your certifier) collects the samples; our ISO/IEC 17025:2017 accredited lab incubates, identifies, and reports the organisms recovered, so you have defensible data for your compliance file.
Sample Types We Analyze
Viable Surface Samples
Bacterial and fungal recovery to genus level from TSA and SabDex contact plates collected across each classified area, ISO Class 5 PEC chambers, and pass-through chambers.
Viable Air Samples
Bacterial and fungal recovery from TSA and SabDex impaction plates used to characterize the air inside cleanrooms, buffer rooms, and ante-areas.
Gloved Fingertip Samples
Bacterial and fungal counts from TSA plates pressed by gloved fingertips — a direct readout of garbing technique and aseptic discipline.
Media Fill Samples
Sterility readout for media-fill (process simulation) units, evaluating whether your aseptic compounding workflow can produce a sterile product.
Aseptic Competency Samples
Laboratory analysis supporting personnel competency programs, with results referenced against USP <797> action levels for each ISO class.
Cleanroom Qualification Support
Microbial analysis that supports cleanroom certifications, biosafety cabinet qualifications, laminar flow hood reviews, and compounding isolator commissioning conducted by your certifier.
USP <797> Action Levels by ISO Class
Action levels published in the revised USP <797> chapter guide how facilities respond to recovered colony-forming units (CFU). Our reports cite the matrix, the ISO class context you provide, and the recovered organisms so you can apply these thresholds directly.
Viable Air
| ISO Class | Action Level |
|---|---|
| ISO Class 5 | > 1 CFU per 1,000 L of air |
| ISO Class 7 | > 10 CFU per 1,000 L of air |
| ISO Class 8 | > 100 CFU per 1,000 L of air |
Viable Surface
| ISO Class | Action Level |
|---|---|
| ISO Class 5 | > 3 CFU per media device |
| ISO Class 7 | > 5 CFU per media device |
| ISO Class 8 | > 50 CFU per media device |
Gloved Fingertip
| Scenario | Action Level |
|---|---|
| After garbing | > 0 CFU |
| After media-fill procedure | > 3 CFU total from both hands combined |
Competency Frequency Under the Revised Chapter
Personnel involved in compounding must complete an initial competency evaluation before working unsupervised. Ongoing evaluation cadence depends on the CSP category your facility prepares:
- Categories 1 & 2: at least every six months
- Category 3: at least every three months
- Designated personnel overseeing the program: annual evaluation
Sample Matrices & Recommended Media
| 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 |
Configurable Sampling Kits
We ship configurable subscription kits that bundle everything your facility needs to collect a defensible sample set — pre-poured TSA and SabDex media, gloved-fingertip plates, and media-fill components — packaged for safe transit back to the lab. Choose the cadence and matrices that match your CSP category, and we'll keep the supplies arriving on schedule.
- Surface, air, gloved fingertip, and media-fill components in a single shipment
- Insulated, return-ready packaging with chain-of-custody documentation
- Adjustable cadence — monthly, quarterly, or aligned to your facility's sampling plan
Why Choose Air Allergen for USP <797> Lab Analysis?
- ISO/IEC 17025:2017 accredited laboratory with AI-assisted reporting for faster, more consistent results
- Same-day intake for samples received by 12pm EST
- Bacterial and fungal identification to genus level, reported against USP <797> action levels
- Configurable kit subscriptions with competitive per-sample pricing
- Guidance on interpreting recovered organisms and aligning results with your environmental monitoring plan
Get Started with USP <797> Lab Analysis
Talk to our team about your facility's environmental monitoring program and receive a kit and analysis plan tailored to your CSP categories.