Trial Medical
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| Model NO. | FDNPI03 | Machine Material | Stainless Steel |
|---|---|---|---|
| Packaging Material | Aluminum, Glass, PVC | Warranty | 24 Months |
| Transport Package | Wooden Package | Production Capacity | 1000 Pieces/Year |
| Features | Batch Coding, Print Registration Control, Sterilization Capability, Tamper-Evident Packaging, Temperature Control, Vacuum Packaging | ||
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 system's key operational areas employ ISPE-recommended RABS (Restricted Access Barrier System) protection, which effectively lowers the risk of product contamination by particles and microorganisms.
Application Scenarios & Functional Equipment:
| Item | Parameter |
|---|---|
| Chamber Cleanliness | Grade A positive-pressure laminar airflow |
| Air Volume | 85-500m³/h |
| HEPA Filter Type | H14 Grade |
| Air Velocity | 0.45m/s ±20% |
| VHP Concentration | 0-5000 ppm |
| Biological Indicator | 6 log Including VHP Sterilization |
| Sterilization Time | 20-60 min |
| Leakage Rate | 0.5 % vol/h @100 Pa |
| Illumination / Noise | ≥500 Lux / ≤65 dBA |
The facility boasts over 100 sets of state-of-the-art, automated production equipment. With experienced engineers and highly skilled technicians, the team provides comprehensive support throughout the powder handling lifecycle—helping customers solve complex challenges and build efficient, flexible, and sustainable production facilities. Solutions are Engineered-to-Order (ETO) to provide enclosed, automated, and intelligent powder and solids handling.
