Remel, a leading manufacturer of high quality microbiology
products, today announced new data demonstrating consistent CFU counts over an 8 hour time
period for reconstituted Quanti-Cult® Plus quality control organisms (when refrigerated).
Pharmaceutical and biotech companies can perform daily quality control testing using the same
vial of reconstituted microorganisms, saving valuable time and money. When refrigerated after
reconstitution, Quanti-Cult® Plus organisms maintain consistent CFU counts (<100 CFUs), in
agreement with testing guidelines cited in the United States Pharmacopoeia (USP). Consistent
CFU counts were confirmed over an 8 hour time period for the bacteria, yeast, and fungi species
which are recommended for Microbial Limits Testing and Sterility Testing in the United States
Pharmacopoeia (USP) Chapters 61, 62, and 71.
Pharmaceutical companies monitor their manufacturing environments for contaminating
microorganisms to ensure they are meeting regulatory guidelines for cleanliness and/or sterility.
In order to perform these tests, USP guidelines recommend the use of ATCC® strains of control
microorganisms for microbiological testing. These microorganisms must deliver <100 CFUs per
inoculum and meet stringent testing requirements. Remel Quanti-Cult® and Quanti-Cult® Plus
products meet these guidelines; are manufactured in an ISO 9001:2000 certified facility and meet
stringent guidelines for consistent results. By verifying CFU consistency over 8 hours, Remel has maximized the benefit Quanti-Cult® Plus products offer parmaceutical customers needing microbiology testing products, helping to ensure the safety and quality of pharmaceutical and
biotechnology products.