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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USP <797> Testing Information
(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|
|Single Plate Method|
(1 plate for bacteria & fungus)
|Bacteria & Fungi||Counts w/ Genus Identification*||SPG||8|
|Counts w/ Species Identification||SPS|
|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|
|Fungal Culture||Fungi Only||Counts w/ Genus Identification*||FG||5|
|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|
(incubated by lab)
|Bacteria & Fungi||Presence/absence of turbidity||STER||2|
|Subculture of positive units w/ species identification growth||STER+IDS||14|
(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
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