Equipment

Aseptic Formulation and Filling Using Isolator Technology

August 01, 2003

Isolator technology can be used in clinical product formulation and filling facilities to ensure environmental control and reduce contamination risk in aseptic processing.

The Clarification of Bioreactor Cell Cultures for Biopharmaceuticals

March 02, 2003

Clarification processes are critical steps in production of biological products because they directly affect yield, product consistency, and reproducibility.

Calibration of Lyophilization Pressure Gauges

June 01, 2002

Measurements of lyophilization pressure are accurate only if the gauges that are used have been properly calibrated.

PDA Task Force Issues Guidelines to Aid Isolator Users

March 01, 2002

When FDA reviewed PDA's Technical Report No. 34 about isolator systems, significant differences of opinion between the organizations came to light.