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Lyophilization

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To keep medication stable in its delivery device, contract manufacturers may need the capability to perform lyophilization services, better know as freeze-drying, to complete the medical device. Lyophilization equipment types include rotary evaporator freeze-driers, manifold freeze-driers, and tray freeze-driers. For items in vials requiring long-term storage, such as vaccines, the freeze-drier equipment uses a stoppering mechanism to seal the vial before it is exposed to the atmosphere.

Water content is removed to prevent microorganisms from degrading the substance, often in a three-step process. Material is first cooled below the lowest temperature at which point the solid and liquid stages of the materials can coexist, called the triple point, which is usually between -50 to -80 degrees C. Next, during the primary drying, pressure and heat are added to make the water sublimate, or change directly to its gas state, usually in a partial vacuum in a slow, controlled way to keep the structure from being altered. Lastly, A secondary drying at a slightly higher temperature breaks up remaining connections between unevaporated water molecules and the material, and the vacuum is broken with an inert gas, resulting in a product with generally less than 4% residual water.

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