USP 797

  • ISO 17025 accredited by AIHA-LAP, LLC
  • Incubation/enumeration/identification of bacteria and fungi, media fill testing, biological indicators
  • Lab open on Saturdays
  • Rapid turn-around-time for reports
  • Rental equipment available (SAS Single and Dual Head)
  • Sampling media available

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.

Culture Analysis

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

Test Code Turn-Around Time (days)
Dual Plate Method
(2 plates = 1 plate for bacteria & 1 plate for fungus)
Bacteria & Fungi Counts w/ Genus Identification* BFG 5
Counts w/ Species Identification BFS
Counts only BFC
Single Plate Method
(1 plate for bacteria & fungus)
Bacteria & Fungi Counts w/ Genus Identification* SPG 8
Counts w/ Species Identification SPS
Counts only SPC
Pre-incubated Plate Bacteria & Fungi Counts w/ Genus Identification* IDG 2
Counts w/ Species Identification IDS
Bacterial Culture Bacteria Only Counts w/ Genus Identification* BG 3
Counts w/ Species Identification BS
Counts only BC
Fungal Culture Fungi Only Counts w/ Genus Identification* FG 5
Counts only FC
Blank Sterility Control Bacteria and/or Fungi Incubation and determination of sterility NEGC As per project
Growth Promotion Bacteria and/or Fungi Plate inoculated with 5 ATCC bacterial and fungal strains GPRM As per project
Media Fill
(incubated by lab)
Bacteria & Fungi Presence/absence of turbidity STER 2
Subculture of positive units w/ species identification growth STER+IDS 14
Media Fill
(pre-incubated by customer)
Bacteria & Fungi Subculture of positive units w/ species identification of growth STER-PRE 5

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

Equipment Rentals

U.S. Micro Solutions is pleased to provide our clients with low-cost rental equipment for field sampling.

Get in Touch

To learn more about our services or to get more information, please contact us
by calling (724) 853-4047 or by using our contact form.