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August 01, 2014
Single use has introduced a level of flexibility into facilities that was either unheard of or very expensive in a stainless-steel environment.
July 02, 2014
The authors look at the cleanability of pharmaceutical soils from a variety of materials of construction to determine the relative ease of cleaning and explore potential grouping strategies as part of a comprehensive cleaning validation program.
May 21, 2014
Gowning practices embody cGMPs and can be a tool to evaluate cGMP compliance.
May 15, 2014
What is a modular system and how are modular systems being used in the biopharmaceutical industry? Pär
April 15, 2014
The authors describe how modular systems can be applied to continuous solid-dosage and nutraceutical manufacturing.
March 13, 2014
Walker Barrier Systems builds eight mobile clean rooms for the Texas A&M Center for Innovation in Advanced Development and Manufacturing.
October 02, 2013
The authors evaluated a variety of materials of construction (MOCs) and found that visible residue limits (VRLs) were higher on some MOCs than on stainless steel. The optimal viewing conditions were dependent on the MOC and the viewing background. The risk of a cleaning failure due to visual failure for different MOCs can be mitigated or eliminated using complementary cleaning validation studies.
September 25, 2013
GE Healthcare Life Sciences announced that it will build a KUBio modular biopharmaceutical factory in China for JHL Biotech.
September 11, 2013
FDA specifies the DUNS UFI system for registration of domestic and foreign drug establishments.
September 09, 2013
Mylan completes expansion of its transdermal patch facility in Vermont.