Fabtech recently commissioned a closed loop granulation line project for a leading pharma manufacturer in the Persian Gulf. Our scope included conceptualisation, consultation for the API + OSD formulation facility to the execution of oncology products (NIB type) for Occupational Exposure Level 4 (OEL 4).
The Granulation system is a complete wall flush unit with a common SCADA operation system and single screen operation. It comprises a High Shear Mixer with a charging and sampling Isolator, and a positioning system with Alpha Beta Split butterfly valves manufactured by Fabtech. A Wet Milling Comill leads granules to the Fluid Bed Dryer with a tangential flow sieve thereby enabling spiral motion of fluidisation while ensuring uniform drying. Dried products are discharged into a Vacuum transfer device and the product is milled and sieved within the Isolator and fed to the Blender Bin with passive Split Butterfly Valves. The Blender Bin comes with a manual lifting trolley (worm wheel type) that makes for easy docking in the Blender. The complete system is flame-proof.
The entire system adheres to 21 CFR part 11 as well as cGMP guidelines. Sensors measure process endpoints but also endpoints for cleaning and validation.
- Spiral Tangential Flow Sieve for Fluid Bed discharge into Vacuum Transfer System.
- Leak-proof High Shear mixer and Fluid Bed dryer to maintain the highest levels of containment.
- Specially designed sampling valves as well as cleaning nozzles to ensure the validation of system is perfect.
- All containment equipment filters incorporate the BIBO system for hassle-free filter changing procedures.
We also provided a multi-purpose washing station for bin washing bottles, blender bins and other equipment. The station is designed to incorporate manual half suit entry for flexibility of use. This also helps clean parts that are tough from a validation perspective.
We designed the API section with reactors (with contained charging Isolator), Agitated Nutsche filter dryer, Micronizing Mill with complete containment OEL 4. An IPQC Isolator with instruments like weigh balance, disintegration apparatus, oven friability tester, hardness tester and Karl Fisher apparatus (moisture analysis) completes the system.
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This post originally appeared on the Fabtech blog.