How Is Lyophilized Powder Produced?

Lyophilized solution filling capping machineLyophilization Process for Vial Powder Injections

The sterile lyophilization process involves freezing the moisture in drugs or biological products at low temperatures under sterile conditions, followed by sublimation of ice crystals under vacuum to achieve drying. This process preserves the product's activity and stability, avoids thermal decomposition and deterioration, and offers good reconstitution properties with minimal contamination risk. The entire procedure must be conducted under strictly controlled temperature, freezing rate, and vacuum conditions. Next, we will examine the working principles of the equipment used in this process alongside the video.

Lyophilized Powder Production Equipment:

• Cleaning and Sterilization System:

• One horizontal stopper washing machine

• One vertical aluminum cap washing machine

• One sterilization cabinet with an integrated isolator

• Solution Preparation System:

• Consists of a feeding isolator, a high-concentration mixing tank, a low-concentration mixing tank, a storage tank, a CIP (Clean-in-Place) station, and an automated control system.

• Production Line Configuration:

• One vial washing-drying-filling-capping integrated line

• Two lyophilizers with a fixed automatic loading/unloading system

• One external vial washing machine

• Supporting ISOLATOR aseptic isolators

  
  

• Inspection and Packaging Equipment:

• One automatic visual inspection machine

• One labeling machine

• One fully automatic cartoning machine

• One 3D wrapping machine

• One fully integrated system for automatic case opening, boxing, sealing, strapping, and palletizing.