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.

 

Test Code Culture Analysis

(Bioaerosol, Contact/Surface, Gloved Fingertip, Personnel Garment)

Turn-Around Time (days)
BFG Dual Plate Bacteria & Fungi  Counts w/ Genus Identification* 5
BFS Dual Plate Bacteria & Fungi  Counts w/ Species Identification 5
BFC Dual Plate Bacteria & Fungi  Counts only 5
SPG Single Plate Bacteria & Fungi  Counts w/ Genus Identification* 8
SPS Single Plate Bacteria & Fungi  Counts w/ Species Identification 8
SPC Single Plate Bacteria & Fungi  Counts only 8
IDG Pre-incubated plate Bacteria & Fungi  Counts w/ Genus Identification* 2
IDS Pre-incubated plate Bacteria & Fungi  Counts w/ Species Identification 2
BG Single Plate Bacteria only Counts w/ Genus Identification* 3
BS Single Plate Bacteria only Counts w/ Species Identification 3
BC Single Plate Bacteria only Counts only 3
FG Single Plate Fungi only Counts w/ Genus Identification* 5
FC Single Plate Fungi only Counts only 5

* Species identification automatically performed for coagulase-positive staphylococci, gram-negative organisms, and yeast.

Test Code Sterility Analysis Turn-Around Time (days)
SPOR Biological Indicators (Spore Strip Sterility Test) 2
STER Media Fill (low, medium, high risk) 7-14
Test Code Sterility Analysis Turn-Around Time (days)
SPOR Biological Indicators (Spore Strip Sterility Test) 2
STER Media Fill (low, medium, high risk) 7-14

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.