What is the Purpose of
USP <797> Testing?

USP Chapter <797> Pharmaceutical Compounding Sterile Preparations (CSP) provides minimum practice and quality standards to prevent microbial contamination of CSPs. This chapter applies to all facilities which prepare, store, and/or transport CSPs, such as hospitals and other healthcare institutions, treatment clinics, pharmacies, physician offices, and 503B outsourcing facilities.

Why Choose U.S. Micro-Solutions?

  • Accredited by CDC ELITE, New York ELAP, AIHA-LAP LLC
  • Immediate notification of positive results
  • Lab open on Saturdays
  • Incubation/enumeration/identification of bacteria and fungi, media fill testing, biological indicators
  • Rental equipment available (SAS Single and Dual Head)
  • Sampling media available

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How It Works


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Order Your Test

Complete the Chain of Custody and ship samples.

We Do Our Work

Our experienced team analyzes the samples.

You Get Results

We immediately notify you of positive results & send a final report within 1-2 business days of analysis completion.

USP <797> Testing Information

Culture Analysis

(Bioaerosol, Contact/Surface, Gloved Fingertip, Garbing, Media Fill)

Test CodeTurn-Around Time (days)
Dual Plate Method
(2 plates = 1 plate for bacteria & 1 plate for fungus)
Bacteria & FungiCounts w/ Genus Identification*BFG5
Counts w/ Species IdentificationBFS
Counts onlyBFC
Single Plate Method
(1 plate for bacteria & fungus)
Bacteria & FungiCounts w/ Genus Identification*SPG8
Counts w/ Species IdentificationSPS
Counts onlySPC
Pre-incubated PlateBacteria & FungiCounts w/ Genus Identification*IDG2
Counts w/ Species IdentificationIDS
Bacterial CultureBacteria OnlyCounts w/ Genus Identification*BG3
Counts w/ Species IdentificationBS
Counts onlyBC
Fungal CultureFungi OnlyCounts w/ Genus Identification*FG5
Counts onlyFC
Blank Sterility ControlBacteria and/or FungiIncubation and determination of sterilityNEGCAs per project
Growth PromotionBacteria and/or FungiPlate inoculated with 5 ATCC bacterial and fungal strainsGPRMAs per project
Media Fill
(incubated by lab)
Bacteria & FungiPresence/absence of turbiditySTER2
Subculture of positive units w/ species identification growthSTER+IDS14
Media Fill
(pre-incubated by customer)
Bacteria & FungiSubculture of positive units w/ species identification of growthSTER-PRE5

* Species identification of Gram-negative rods, coagulase-positive staphylococci, and yeast via MALDI-TOF mass spectrometry automatically performed