Industry Challenge

BioPharm GmbH, a leading biopharmaceutical manufacturer in Germany, faced critical challenges with their aging freeze-drying vacuum system. The existing oil-sealed rotary vane pumps were causing contamination concerns in their sterile manufacturing environment.

Critical Requirements

The facility produces high-value biologics and vaccines requiring absolute contamination-free environments. Any oil vapor backstreaming could compromise entire production batches worth millions of euros. Additionally, strict EU GMP regulations demanded validated, reliable vacuum systems with comprehensive documentation.

Operational Constraints

The upgrade had to be completed during a planned shutdown window of just 10 days. The new system needed to integrate seamlessly with existing freeze-dryers and maintain validated temperature profiles critical for product stability.

Technical Solution

We designed and implemented a comprehensive oil-free vacuum solution featuring three SDHV-120 dry screw vacuum pumps configured in a 2+1 redundant arrangement. This configuration ensures continuous operation even during maintenance of one unit.

System Integration

Each pump is equipped with advanced PLC integration allowing real-time monitoring of critical parameters including vacuum level, motor temperature, and vibration. The system communicates via PROFIBUS protocol with the existing facility management system.

Safety & Compliance

All equipment was supplied with comprehensive Factory Acceptance Testing (FAT) documentation, followed by on-site Installation Qualification (IQ) and Operational Qualification (OQ). Performance Qualification (PQ) was executed in collaboration with the client’s quality assurance team.

Installation Process

Our engineering team completed the installation during the scheduled 10-day shutdown. Pre-fabricated piping assemblies and detailed installation drawings enabled efficient execution. The system was commissioned and validated within the planned timeframe, allowing production to resume on schedule.