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Email ：PharmaSources@imsinoexpo.com
Whatsapp ：+86-13621645194
Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East
Contract Manufacturing: CRO,CMO
Delivery Lead Time: 2 months
Sample Provided: no
Payment Terms: T/T
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.
The high-efficiency filter uses a negative pressure sealing method to prevent the sealing material from falling off and generating dust under high temperatures.
The cooling section uses water cooling and a flow equalizing device to adjust the airflow, ensuring uniform wind speed and good temperature uniformity within the chamber.
The air pressure balance structure ensures the pressure difference between the preheating section, heating section, cooling section, and the washing area, maintaining a stable pressure gradient in each section of the oven and ensuring an FH value of ≥1365.
The heating section uses PID control to avoid thermal overshoot effects, ensuring uniform temperature distribution.
The oven has production mode (day mode) and standby mode (night mode), allowing intelligent selection based on production status.
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
Audited Supplier
Pharma Sources Insight June 2024: Globalization on the Go
