microbiology specialists inc.
Pharm Micro Assurance

Pharm Micro Assurance

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>

Anti-microbial effectiveness testing
Chapter <61>

Microbial examination of nonsterile products
Chapter <62>

Microbiological examination of nonsterile products:
Tests for specified microorganisms.

Chapter <85>

Endotoxin Testing
Chapter <797>

Media Fill Testing
Air monitoring of Clean room and IV prep areas
Gloved fingertip testing
End product sterility testing

 

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