Elements of the design included provisions for the powder micronization, conditioning, milling, blending, capsule filling, blister packaging, case packing, and palletizing of a lactose/level3
compound product with special environmental conditioning requirements.
The production areas were designed to Classes 10,000 and 100,000 per FDA and EU requirements. A unique element of the operation was raw materials, work in progress (WIP), and
finished goods staging occurred in GMP spaces via an automated storage and retrieval system (ASRS).
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