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

Get Started Today

Our team is happy to answer any questions you have. If you're ready to become a customer, complete our Become a Customer form!

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How It Works

1

Become a Customer

Complete our New Customer Application Form.
2

Order Your Test

Complete the Chain of Custody and ship samples.
3

We Do Our Work

Our experienced team analyzes the samples.
4

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

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