The project was developed for a state-of-the-art production site dedicated to the manufacture of solid oncology drugs. The plant operates with high-potency active pharmaceutical ingredients (HPAPI) in OEB5 class, where dust control is a critical requirement for operator safety and compliance with international regulations. The challenge was to implement a centralized dust containment system for 3 tablet presses (flow rate 450 m³/h) in an ATEX Zone 22-classified environment.
The pharmaceutical powders handled include high-potency APIs and critical excipients. The main technical challenges included:
- Safety: handling of toxic powders in OEB5 risk class.
- Classification: operation in an ATEX Zone 22environment.
- Containment: need to ensure OEB5 dust containment during production and OEB4 during maintenance and unloading.
- Integration: simultaneously serving 3 tablet presses while maintaining system integrity.
- Monitoring: constant monitoring of filter integrity via DOP ports.
SOLUTION: PHARMA40.40DCZ22 SPECIAL CONFIGURATION
Delfin has designed a PHARMA40.40DCZ22 unit in a special configuration for oncology applications:
- Power and Containment: 4 kW system tested to OEB5 (operation) and OEB4 (maintenance) standards.
- Integrated Technology: WIP (Wash-In-Place) system, stainless steel clamps, and Photohelic ATEX instrumentation with visual/audible alarms.
- Automation: electrical panel with integrated inverter and interface with electro-pneumatic butterfly valves.
- Smart design: a single compact machine serves three tablet presses simultaneously, eliminating the need for three separate units.
The project successfully passed the rigorous Factory Acceptance Test (FAT).
Benefits: efficiency and safety
- Energy Savings: reduced consumption thanks to centralized extraction in a single machine.
- Lean Production: maximum optimization of space in sterile and production areas.
- Complete certification: Full ATEX compliance for the extraction of combustible dusts in an ATEX Zone 22 area.
- Total Protection: Achievement of the highest level of operator protection (OEB5) against toxic dusts.
- Competitive Advantage: A technically advanced and more efficient solution compared to standard configurations available on the market.
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