U-Care Medical
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Sterile API Isolation and Filling System
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 operational areas employ ISPE-recommended RABS (Restricted Access Barrier System) protection, which maximally reduces personnel and material contact probability, effectively lowering the risk of product contamination.
Application Scenarios:
| No. | Item | Parameter |
|---|---|---|
| 1 | Chamber cleanliness | Grade A positive-pressure laminar airflow |
| 2 | Air volume | 85-500m3/h |
| 3 | HEPA filter type | H14 Grade |
| 4 | Air Velocity | 0.45m/s ±20% |
| 5 | VHP Concentration | 0-5000 ppm |
| 6 | Sterilization Time | 20-60min |
| 7 | Leakage Rate | 0.5 % vol/h @100 Pa |
| 8 | Noise Level | ≤65 dBA |
The factory currently boasts over 100 sets of state-of-the-art, automated production and processing equipment. With experienced engineers and a dedicated manufacturing team, our products are trusted by over a thousand pharmaceutical companies globally. Our mission is to "Simplify the Ordinary and Make Material Handling Easier," providing professional support throughout the powder handling lifecycle to help customers build efficient and sustainable production facilities.
