microbiology specialists inc.
Pharmaceutical (USP) Compliance Testing

Pharmaceutical (USP) Compliance Testing

Compounding pharmacies, Stem Cell Facilities and Core Blood Facilities

The United States Pharmacopeia (USP) reference standard was established to assist the Food and Drug Administration (FDA) in publishing standards by which laboratories could help to ensure sterility of products. In recent years these products have included compounded sterile preparations (CSP’s), as well as stem cell and core blood facilities.

msi offers testing to the following Chapters:

Chapter <51>

Antimicrobial effectiveness testing
Chapter <61>

Microbiological Examination of Nonsterile Products: Microbial Environmental Test
Chapter <62>

Microbiological examination of nonsterile products:
Tests for specified microorganisms.

Chapter <71>

Sterility Tests

Chapter <85>

Endotoxin Testing
Chapter <797>

Pharmaceutical Compounding – sterile preparations

Chapter <1116>

Microbiological Control and Monitoring of
Aseptic Processing Environments

 

Other services offered by msi include consultative services regarding pharmacy design, training and certifying pharmacy personnel in sterile technique, and environmental monitoring.