Automated and validated cleaning process
Freeze drying is the removal of ice or other frozen solvents from a material through the process of sublimation and the removal of bound water molecules through the process of desorption.
Lyophilization and freeze drying are terms that are used interchangeably depending on the industry and location where the drying is taking place. Controlled freeze drying keeps the product temperature low enough during the process to avoid changes in the dried product appearance and characteristics. It is an excellent method for preserving a wide variety of heat-sensitive materials such as proteins, microbes, pharmaceuticals, tissues & plasma
LYOPHILIZATION PROCESS OVERVIEW
The steps required to lyophilize a product in a batch process can be summarized as follows:
- Pretreatment / Formulation
- Loading / Container (Bulk, Flask, Vials)
- Freezing (Thermal Treatment) at atmospheric pressure
- Primary Drying (Sublimation) under vacuum
- Secondary Drying (Desorption) under vacuum
- Backfill & Stoppering (for product in vials) under partial vacuum
- Unloading of the Dried Product from Freeze Dryer
Before the freeze drying process takes place, there are other ancillary processed they may be carried out: clean-in-place (CIP), sterilization-in-place (SIP), inlet filter integrity test and leak test.
In addition to providing an extended shelf-life, successful freeze-drying also yield a product that has a short reconstitution time with acceptable potency levels. The process should be repeatable with well defined temperature, pressure and time parameters for each step. Visual and functional characteristics of the dried product.
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Established in 1963, provides global solutions in areas like Life and Sciences, Scientific R&D, and Development and its operations are witnessed in over 100 countries. Based in Terrassa, a town close to the dynamic metropolitan area of Barcelona (Spain), Telstar currently has a team of 850 highly qualified employees.