June 6th 2025
ICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products.
Sterility Test Isolators for Aseptic and Toxic Drug Products are Ergonomically Designed
May 24th 2018The sterility test isolator (STISO) for testing aseptically filled drug products and for testing toxic aseptic drugs (STISOtox) from Metall+Plastic, a subsidiary of Optima, are modular and ergonomically designed.
Impact of Agitator Design on Bioreactor Performance
May 15th 2018Aerobic bioprocesses are highly dependent upon the oxygen transfer rate (OTR) from sparged to dissolved gas. The relatively low solubility of oxygen, however, makes the choice of mixer impeller configuration a critical design factor for the bioreactor vessel. This article describes a series of experiments and computational fluid dynamics (CFD) simulations to detail the effect of mixer configuration on the efficiency and effectiveness of a bioreactor vessel with respect to blend time and mass transfer.
Establishing Acceptance Limits for Uniformity of Dosage Units: Part 3
May 2nd 2018The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.