DRY POWDER INJECTABLES

Surge has dedicated self contained facility of Sterile Cephalosporin Injectable Glass Container washing is carried out under HEPA filtered air. Further area is protected with LFH, filtered distilled water and compressed air through 0.2m filters (30 to 50psi ) to protect the vials (during washing) from foreign particles. Filling, Rubber Stoppering and sealing of Vials LFH with 60 ft/min. +20% (vertical) air velocity and air changes (60/min) in filling room are designed while Positive pressure in all aseptic areas for 24 hours. Dehumidifier (Sweden) is provided in Dry Powder Injectable area to control the relative humidity NMT 30%. Packing Operations are performed under verification of QA. Quality Risk Management Principles are implemented effectively for Product Quality, Safety, Purity & Efficacy.

Separate Air handling units for each area to avoid cross contamination & contamination. HVAC based on Federal standard 209 E. Air-Handling Units are provided with Terminal HEPA filter at 99.97% efficiency and critical processes are further protected by LFH.