Question

Freeze drying process takes impurities out with water removed

Answer 1

Inspection Guides > Lyophilization of Parenteral (7/93) - FDA Lyophilization or freeze drying is a process in which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase.


Lyophilization, defined as a freeze-drying process that removes water from a product after it is frozen and placed under a vacuum, is often messy, but filled with possibilities for potential applications.

Some of the typical pharmaceutical products that would undergo lyophilization include bulk pharmaceutical/biopharmaceutical ingredient (chemical or biologics found in nature), protein, collagen, peptide, oligonucleotide, chemical API, enzymes, and mAbs.