Blow-fill-seal (BFS) provides a sterile solution for aseptic technology by reducing human intervention in the fill/finish process that is expanding very fast and consider to be an advanced aseptic ...

Pharmaceuticals packaged by blow molding, sterile filling, and hermetic sealing, which require minimal operator intervention, are less prone to contamination and can have ergonomic features like ...

The authors propose a process-centric approach for carrying out aseptic-processing and suggest further dialogue. This articles contains bonus online-exclusive material. There's been a steady stream of ...

Aseptic blow-fill-seal (B/F/S) systems for the processing of pharmaceutical liquids have experienced rapid and growing acceptance by the pharmaceutical industry over the past 20 years. This has been ...

Traditionally, vaccine manufacture has accounted for a huge amount of aseptic production. In recent years, there has been a larger focus on novel biologic therapies, of which the majority are ...

This article outlines improvements and changes to non‐viable particle monitoring (NVP), sometimes referred to as total particulate monitoring, which during aseptic processing, is a regulatory ...

This article presents a study of an aseptic environmental monitoring system for surface contamination at critical areas using a robot. Robotic sampling can be applied to the surface sampling of ...

According to the National Cancer Institute, immunotherapies that enlist and strengthen the power of a patient’s immune system are the “fifth pillar” of cancer treatment adding to surgery, chemotherapy ...

To assure patient safety, biologics developers and manufacturers must carefully consider where contaminants could be introduced to the drug substances (DSs) or drug products (DPs) at all stages of the ...