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Key Takeaways:
- Evonik implemented the AseptiSafe® Bio Valve and STERIS VHP™ 1000ED unit to enable aseptic, high-throughput powder transfer in Grade A (ISO 5) cleanroom.
- The VHP® 1000ED enabled 45-minute validated cycles, allowing near-continuous operation with minimal downtime.
- The split butterfly valve maintained a sterile, sealed connection—preventing particulate release during container changes.
- Mobile, flexible deployment supports cleanrooms with spatial constraints and varying layouts.
- The system complies with EU GMP Annex 1, improving both operational safety and production efficiency.
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.
