This article is the first in a three-part series exploring the need and means to achieve improvement in aseptic processing of sterile biopharmaceutical products. Part 1 presents the current state and opportunity for improvement using innovative technology. Part 2 further discusses some of the changes in strategy that might be needed for and result from the use and improvement of technology. Part 3 presents the impact of technology changes.
A collaborative study involving Cardinal Health, Inc. and Air Dispersions Ltd. has been carried out to further the understanding of the extrusion process and its impact upon the quality of Blow/Fill/Seal product.
Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and process that provide critical advantages for sustainable initiatives.
A collaborative study with a new customer with the objective of taking an existing, smaller preclinical E. coli process previously performed in stainless steel vessels and scaling it up quickly using the Thermo Scientific™ HyPerforma™ 300 L Single-Use Fermentor (S.U.F.)
In the processing of ophthalmic solutions, high-shear mixers are utilized for dissolving salts as well as dispersing viscosity enhancers, antioxidants and other additives.
A majority of pharmaceutical gels are shear-thinning semisolids prepared by dispersing hydrophilic polymers into an aqueous vehicle. Proper mixing requires a good balance between agitation and shear.
Dry blending is an indispensable operation in the manufacture of multivitamins, sports supplements, herbal extracts, meal-replacements, green food powders and other nutraceutical products.