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Complete stoppering of the vials usually by hydraulic or screw rod stoppering mechanisms installed in the lyophilizers.

Applying a vacuum to the chamber and heating the shelves in order to evaporate the water from the frozen state.

Freezing the solution by placing the partially stoppered containers on cooled shelves in a freeze-drying chamber or pre-freezing in another chamber.

Transporting the partially stoppered containers to the lyophilizer and loading into the chamber under aseptic conditions.

Filling into individual sterile containers and partially stoppering the containers under aseptic conditions.

Sterilizing the bulk solution by passing it through a 0.22 micron bacteria-retentive filter.

Dissolving the drug and excipients in a suitable solvent, generally water for injection (WFI).

The lyophilization process generally includes the following steps:

Need for sterile diluent upon reconstitution Rapid and easy dissolution of reconstituted product Removal of water without excessive heating of the productĮnhanced product stability in a dry state The advantages of lyophilization include:Įase of processing a liquid, which simplifies aseptic handling The process consists of three separate, unique, and interdependent processes freezing, primary drying (sublimation), and secondary drying (desorption). 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.

The document does not bind FDA, and does no confer any rights, privileges, benefits, or immunities for or on any person(s). Note: This document is reference material for investigators and other FDA personnel. GUIDE TO INSPECTIONS OF LYOPHILIZATION OF PARENTERALS