Project Requirements

A major pharmaceutical manufacturer planned a significant expansion of their European production capabilities, designing one of the continent’s most advanced high-containment facilities for solid dosage manufacturing. The new plant would produce billions of tablets and capsules annually for oncology, cardiovascular, and specialty therapeutics— handling potent compounds requiring occupational exposure limits below 1 µg/m³. During the planning phase,

Andocksysteme worked closely with the customer’s engineering team to identify the optimal containment solution for each critical powder transfer point. At the roller compactor inlet, where powder blends are charged into the dry granulation process, the project team identified several key requirements:

• Closed transfer capability to prevent operator exposure during IBC connection and powder discharge, where fine
  particles are most likely to become airborne
• Validated containment performance for materials with OEL <1 µg/m³, meeting modern containment philosophy
  requirements from the project’s inception
• Multi-product campaign flexibility with validated cleaning procedures and reliable cross-contamination prevention between product changeovers
• Documentation supporting the customer’s GMP qualification activities
• Long-term reliability for a major capital investment requiring proven technology over decades of continuous
  operation
• Mechanical robustness to handle real-world docking conditions with mobile IBCs in a high-volume production
  environment

Based on more than 30 years of successful partnership and proven performance across the customer’s manufacturing
network, Andocksysteme was engaged early in the facility design process to specify containment interfaces for all highpotency powder handling points.