The process of freeze drying sterile pharmaceutical products normally is defined as the set of actvites that start with
- Cleaning In Place
- System Sterilization and Cool Down
- Loading of product manually or automatcally
- Primary drying
- Secondary drying
- Stoppering vials either Pre Aerated with inert gas, or under vacuum
- Unloading manually or automatically
- Ready for the next cycle starting with CIP.
The process of drying non sterile products may eliminate many of these steps such as automated cleaning, elimination of sterilization, cool down after sterilization, and perhaps even stopperng of vials after dryng is completed. Stoppering may not be needed because products can also be dried in pans, and not require stopperiing at all. Some products that are dried in bulk are sponges used as sutures, medical devices such as diagnostcs, capacitor ink, food, finely milled precious metals, intricate molded shapes, oral medicines, and many others that are routinely freeze dried. Many of these products are automatically loaded and unloaded in trays or pans. If freeze drying in a flask on the port of a research freeze dryer, one may also eliminate the actiivities associated with fostering the completion of the drying process including primary and secondary drying although these phases actually occurr as sublimation and desorption phases, without one’s active partcipation.
The commonality is freezing by some means prior to loadng, followed by priimary and secondary drying, and unloading.
Call upon Applewood Scientific if you are in need of guidance in choosing the set of activities necessary to plan a project that may include freeze-drying [lyophilization] as a unit operation for any of your new products. Applewood Scientfic can help you to choose the optional freeze drying steps required for FDA and non cGMP products. We look forward to your inquiries.