Category:
Sterilizing installation
Composed of a conveyor system, preheating section, heating section, cooling section, air pressure balance system, and control system, the hot air circulation sterilization oven is used for drying, sterilizing, and depyrogenating vials.
Machine Parameters:
Serial No. | Item | Parameter Description |
---|---|---|
1 | Machine Dimensions (L×W×H) | ≈2400×2150×2400mm |
2 | Weight | ≈2300kg |
3 | Power Supply | 3P/AC380V/50HZ, 50kW |
4 | Machine Structure | Modular monolithic |
5 | Applicable Specifications | 10ml vials |
6 | Production Capacity | 50 vials/min (based on national standard 10ml vials) |
7 | Vial Output Height | 950mm±20mm |
8 | Container Range | Height 30-120mm |
9 | Manufacturing Standards | cGMP |
10 | Electrical Standards | IEC 60204-1 Safety of machinery – Electrical equipment of machines, GB/T 4728 Graphical symbols for electrical diagrams |
11 | No-load Thermal Distribution | ±8℃ |
12 | Vial Output Temperature | Not higher than room temperature by 10°C |
13 | Biological Indicator Challenge Test | Endotoxin reduction by 3 logs |
14 | Thermal Penetration Test | FH value ≥1365 |
15 | Pressure Differential Requirements | The functional sections inside the tunnel maintain a slight positive pressure relative to the washing and drying area, with the internal pressure gradient being preheating section < high-temperature section > cooling section |
16 | Inter-functional Pressure Differential | Pressure differential between the washing and drying area and the filling area: 15-30Pa, with instantaneous pressure fluctuation not exceeding 8Pa |