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Large Scale Powder Manufacturing |
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Manufacturing Operations |
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SAFC's
state-of-the-art cGMP manufacturing facility is designed for milling and blending
powdered media on the scale required by the customer. Utilizing Air Classification
Mill and Vertical Ribbon Blender Technology, the validated continuous flow
manufacturing process provides a combination of scalability (40-3500 kilograms),
flexibility, consistency, and quality assurance that is unachievable with other
technologies.
The powder manufacturing area of the cell culture facility is
completely segregated from the liquid production area and includes dedicated
equipment
for weighing, milling, blending and packaging of powder media or buffers.
The
Air Classification Milling (ACM) process features variable-speed impact mill
that reduces a variety of dry bulk material to uniform particle size.
The mill puverizes bulk material fed into the grinding chamber via impactors
that are fixed to a high-speed rotating disc. The resulting powder is drawn
by airflow to an independently driven radial flow separator which allows particles of the desired size to pass through to the blender, while larger particles may pass
through the separator, while
larger particles are returned to the grinding chamber. |
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Air Classification Milling (ACM) for tighter control of particle size and continuous processing |
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Flexible capabilities to effectively handle quantities
ranging from kilograms up to single 3,500 kilogram batches -- and shipping
in bulk containers or filling into smaller pouches or bottle |
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Cell Culture cGMP Manufacturing & Quality Systems (661Kb) |
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Packaging and shipping in bulk containers or filling into smaller pouches or bottle |
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Cell culture products are produced under cGMP conditions in compliance with FDA guidelines |
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All critical systems, equipment and processes are fully validated |
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Clean-inPlace System services all major production equipment, from tanks and lines to mills and blenders |
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