CarniTe Machinery
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System Overview: This system is a fully integrated solution developed in strict compliance with the new GMP requirements, applicable to sterile powder production processes such as sterile lyophilization, crystalline drying, spray drying, and sterile powder injections. It utilizes automation and containment measures to minimize and isolate manual interventions, thereby ensuring aseptic process integrity.
The key aseptic processes include vacuum discharge into the powder mixing tank, manual sealed transfer of the mixing tank, sterile powder milling and granulation, automated lifting and mixing, automatic filling, automatic capping, automated nitrogen purging, and automated heat sealing.
| No. | Performance Item | Parameter Details |
|---|---|---|
| 1 | Chamber Cleanliness | Grade A positive-pressure laminar airflow |
| 2 | Air Volume | 85-500m³/h |
| 3 | HEPA Filter Type | H14 Grade High-Efficiency Particulate Air Filter |
| 4 | Air Velocity | 0.45m/s ±20% |
| 5 | Leakage Rate | 0.5 % vol/h @100 Pa |
| 6 | Pressure Differential | 0-85pa ±5pa |
| 7 | VHP Sterilization | 6 log Biological Indicator reduction |
The factory boasts over 100 sets of state-of-the-art, automated production and processing equipment, integrated throughout all manufacturing processes. With experienced engineers and highly skilled technicians, the company provides comprehensive support throughout the powder handling lifecycle—helping customers solve complex challenges and build efficient, flexible, and sustainable production facilities.
