API Manufacturing

Pharmaceutical Manufacturing Services Aligned to Support the Entire Lifecycle.

Alcami’s US API manufacturing center is housed in a state-of-the-art cGMP facility with 70 cubic meters of capacity. The site has all of the capabilities required to provide API clinical and commercial manufacturing services, including high-potency API manufacturing. The facility has a wide range of technologies including plant scale hydrogenation and cryogenics (-90C).

Alcami’s Germantown, Wisconsin Facility Features:

• Reactors:
• 4 x 2000 Gal GLS
• 2 x 1500 Gal 316 SS
• 4 x 1000 Gal GLS
• 2 x 1000 Gal 316 SS
• 1 x 500 Gal GLS
• 2 x 500 Gal 316 SS
• Cryogenic Vessel:
• 1 x 500 Gal 316 SS
• 1x 1000 Gal SS work up
• Hydrogenation Vessels:
• 1 x 500 Gal Hastelloy
• 1 x 1000 Gal
• Solvent Tank Farm
• 5 x 8000 Gal Solvents
• 4 x 8000 Gal Waste

• Separation Equipment:
• 2 x 800 mm Kraus Maffei Horizontal Peeler Centrifuges
• Drying Equipment:
• 2 x 800 Liter Kraus Maffei  Agitated Cone Dryers
• Stokes 438 Tray dryer
• 3 x 4 m2 SS 316 AFD with glove box
• 1.4 m2 Hastelloy AFD with glove box
  
• Therminol Single Fluid System (-30 to 150^oC)
• Cryo to -100^oC
• <20 mm Hg Vacuum
• PLC control with data acquisition
• Fully validated

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