放射性药物
制药
ATMP 细胞和基因治疗
服务
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Customer
PROCOS CBC Group, Italy
Customer Challenge
Build a multi-purpose HP API production facility with containment isolators for QC laboratory with HPLC preparative, wet analysis, dry analysis, particle size and IR analysis processes in Isolator.
Performance Requirements
- OEB 6 – 30 ng/m3 – 8h TWA
- Internal ATEX ZONE 3G/3D IIB/IIC T3 (ZONE 2/22)
- Instruments integration: analytical scale, magnetic and ultrasonic stirrer, coulometer, titration unit, wet digester with vent scrubber, IR spectrum and particle size analyzer
Solution Highlights
Comecer Engineering studied, designed and built 4 isolators with total instruments integration. Project duration: 6 months from study to installation, including 3 months for manufacturing.
- Complete custom isolators design to fit all the laboratory processes
- Push-Push filtration for high containment requirement
- Double continuous liner for material in/out, installable as required for OEB6 products
- Special integration for laboratory instruments, electrical connections, data connections, fluid connections with perfect containment fitting from outside to inside isolators
地点: Cameri
类别: Pharma
