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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.
June 01, 2003
Sterilizing grade filters are widely used in the biopharmaceutical industry and were once thought of as being perfect. However, these filters have experienced rapid developments and improvements during the last decade, which have resulted in enhanced thermal and mechanical resistance. Moreover, their performance levels have been raised, which has led to significant cost savings within production processes.
December 01, 2002
Ultrafiltration is a pressure-driven membrane filtering process used to separate and/or purify dissolved or suspended particles from water and other liquids. Recent advances in materials and membrane manufacturing techniques have led to ultrafiltration playing a pivotal role in a number of biopharmaceutical processes, including protein concentration and blood for actionation. This article examines the criteria that should be considered when selecting membranes for such applications.
April 01, 2002
In this study, the authors examine the suitability of 0.45 µm–rated filters to be used as sterilizing and bioburden-reduction filters against significant populations of organisms such as B. diminuta in a wide range of differential pressures.
June 02, 2001
Special considerations and cautions must be adhered to when designing virus safety studies and developing appropriate virus contamination control programs.