Personalized medicine is an evolving field — offering targeted solutions that benefit patients by minimizing side effects and increasing effectiveness. This introduces a need for specialized fill-finish equipment that can efficiently route product into final packaging in an aseptic manner.
Parenteral medications are often packaged in one of two forms: an aqueous solution or a dry powder that is dissolved in a solvent prior to administration. While both forms present unique challenges, powder products are particularly difficult to fill in an aseptic environment.
One of the key requirements for a Grade A level (ISO 5) environment is low particulates. Handling a powder product, which inherently generates particulates, requires precise control.
This case study examines how Evonik, a leading global contract development and manufacturing organization (CDMO), improved its powder transfer process for parenteral drug products without compromising efficiency or safety.
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