Author Archives: Julie Sperry

Automated Rapid Microbial Methods: Taking Environmental Monitoring Testing Out of the QC Labs

Environmental monitoring of clean rooms is an integral part of a pharmaceutical company’s quality control testing program. Analyzing the air, surface, and personnel within cleanrooms helps ensure the manufacturing environment meets mandated standards and that any variations can be addressed. Unfortunately, the traditional method for environmental monitoring is manual, inefficient, and time consuming. Laboratory technicians must travel, sometimes across large campuses, to collect samples in manufacturing suites. Technicians have to gown, take the samples, and travel back across the campus…

Automated, Nondestructive, Rapid Microbial Testing

Automated, nondestructive, rapid sterility and environmental monitoring () Rapid microbial testing methods continue to gain acceptance in pharmaceutical manufacturing, but experience shows that most companies still use traditional methods for their testing. The ability to deliver results in less time than traditional methods provides compelling benefits to manufacturers. Two key areas of microbial testing where these benefits can be realized include environmental monitoring and sterility testing. Microbial testing must be completed throughout the manufacture of pharmaceuticals, including the raw materials…