Sterilization and depyrogenation tunnel

Endotoxin, toxic substance bound to the bacterial cell wall and released when the bacterium ruptures or disintegrates. Endotoxins consist of lipopolysaccharide and lipoprotein complexes.

The endotoxin complex contains many cell wall components including, but not limited to, phospholipids, lipoproteins, and lipopolysaccharides. Lipopolysaccharide is the biologically active portion and it is pyrogenic. Bacterial endotoxin is a synonym for lipopolysaccharide

Water for Injection, Sterile Water for Injection and Sterile Water for Irrigation have an allowable endotoxin limit of 0.25 Endotoxin Units (EU)/ml. (EU=Unit of measurement for endotoxin activity)

Endotoxin limit for Bacteriostatic Water for Injection and Sterile Water for Inhalation have a slightly higher bacterial endotoxin limit of 0.5 EU/ml. as per (USP – Supplement 4a – 1984)

Sterilization and depyrogenation tunnel used for depyrogenization process after washing of containers such as ampoules, vials and tunnel utilizes hot air to assure complete sterilization of pharmaceutical vials. The tunnel washed glass vials onto a stainless steel mesh belt and conveys the vials through preheat, hot and cool zones. In each zone, the vials are subject to HEPA filtered air to prepare them for filling.

Validation of vial tunnel ensures the risk-free transfer of the material from less cleanliness area to higher cleanliness area with cleanroom regulations.

Vial Tunnel Validation Test Procedure: There are 5 test procedures to validate Vial Tunnel

• Air Velocity Measurement
• Integrity Test of HEPA Filters
• Particle Count Test
• Recovery Test
• Air Flow Pattern Test

Sterilization is the Validated process used to render a product free of living microorganisms including bacterial endospores

Depyrogenation: Removal or inactivation of bacterial endotoxin.